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Tramadol
Kinds of Tramadol Selected AbstractsCOMPARATIVE EFFECTS OF TRAMADOL ON VASCULAR REACTIVITY IN NORMOTENSIVE AND SPONTANEOUSLY HYPERTENSIVE RATSCLINICAL AND EXPERIMENTAL PHARMACOLOGY AND PHYSIOLOGY, Issue 10 2008Juliana M Raimundo SUMMARY 1The aim of the present study was to determine the effects of tramadol on vascular reactivity in aortic rings from Wistar-Kyoto (WKY) rats and spontaneously hypertensive rats (SHR). 2Aortic rings, with or without endothelium, were obtained from male WKY rats and SHR (15,20 weeks old) and prepared for isometric tension recording. Aortic rings were precontracted with phenylephrine (10 µmol/L) or 40 mmol/L KCl and then exposed to cumulative concentrations of tramadol (0.1,1 mmol/L). 3Tramadol produced a concentration-dependent relaxation of precontracted aortic rings from WKY rats and SHR, which was not dependent on functional endothelium. Vascular relaxation was significantly greater in rings from SHR than WKY rats. 4The concentration of tramadol necessary to produce a 50% reduction of the maximal contraction to phenylephrine (IC50) in rings with and without endothelium from SHR was 0.47 ± 0.08 and 0.44 ± 0.03 mmol/L, respectively (P = 0.76). 5Tramadol attenuated the contracture elicited by Ca2+ in depolarized tissue, suggesting that it may inhibit L-type Ca2+ channels. However, pretreatment with nicardipine (1 µmol/L) prevented the relaxation induced by tramadol in aortic rings from WKY rats and partially reduced its inhibitory effect in aortic rings from SHR. 6Pretreatment of endothelium-denuded aorta with glybenclamide (3 µmol/L), 4-aminopyridine (3 mmol/L), tetraethylammonium (3 mmol/L) and naloxone (100 µmol/L) did not affect tramadol-induced vasodilation of aortic rings from either WKY rats or SHR. 7Intravenous administration of tramadol (10 mg/kg) to conscious SHR significantly reduced both systolic and diastolic blood pressure from 171.4 ± 5.3 to 129.3 ± 5.3 (P = 0.002) and from 125.0 ± 6.5 to 57.8 ± 8.9 mmHg (P = 0.003), respectively. [source] Basic pharmacology relevant to drug abuse assessment: tramadol as exampleJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 2 2008R. B. Raffa PhD Summary Tramadol is a centrally acting analgesic in widespread use throughout the world. Although there is extensive preclinical, clinical, post-marketing and epidemiological data indicating relatively low , but not zero , abuse/dependence, questions continue to arise about its abuse potential and appropriate regulatory classification. This article considers these questions from the point of view of the basic pharmacology of tramadol. There is nothing unique about tramadol in this regard, but its multimodal mechanism of action, pharmacologically active enantiomers, and active metabolite make it a particularly instructive and relevant example. [source] Women with Pain due to Osteoarthritis: The Efficacy and Safety of a Once-Daily Formulation of TramadolPAIN MEDICINE, Issue 6 2009FRCP, Walter F. Kean MB ChB ABSTRACT Objective., This analysis assesses the efficacy and safety of treatment with a once-daily oral formulation of tramadol for up to 12 weeks compared with placebo in women with moderate-to-severe pain due to osteoarthritis of the knee. Design., Two parallel, placebo-controlled phase III clinical trials were analyzed; patients were randomized to a fixed dosage of Tramadol Contramid® once a day (OAD) 100, 200, and 300 mg daily, or placebo. Outcome Measures., The primary efficacy end points were the percentage difference from baseline of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscale scores for pain and physical function, and the patient global rating of pain relief after 12 weeks of maintenance therapy. Results., The analysis included 405 women receiving tramadol and 280 receiving placebo. At week 12, 179 of 204 women (87.7%) receiving tramadol rated their overall pain relief as effective or very effective compared with 134 of 177 (75.7%) receiving placebo. A time-weighted analysis revealed statistically significant improvements over placebo for all the WOMAC subscale scores across all three dosages. The percentage improvements from baseline of the WOMAC pain scores were significantly better than placebo for the 100-mg (58.8 ± 37.1%, P = 0.018) and 300-mg (58.9 ± 38.8%, P = 0.023) treatment arms; however, the 200-mg dosage was not significant (53.0 ± 38.5%, P = 0.175). The WOMAC physical function scores showed significant improvement for the 100 (56.9 ± 36.4%, P = 0.009), 200 (54.0 ± 33.8%, P = 0.034), and 300 mg (53.4 ± 41.4%, P = 0.043) daily dosages. Conclusion., For moderate-to-severe pain due to osteoarthritis of the knee, women experience significant analgesia and improvement of physical function over time with treatment with Tramadol Contramid® OAD. [source] Improved Cancer Pain Treatment Using Combined Fentanyl-TTS and TramadolPAIN PRACTICE, Issue 4 2007Franco Marinangeli MD ,,Abstract: The aim of the study was to facilitate dose escalation of strong opioids. In this randomized open-label study the influence of tramadol on dose adjustment of transdermal fentanyl in advanced cancer pain control was prospectively evaluated. Seventy patients affected by intractable cancer disease with visual analog scale (VAS) score >3 were enrolled. Thirty-five patients were treated conventionally with increasing transdermal fentanyl dosage as required (group F) and 35 patients received oral tramadol added to their transdermal fentanyl before each increment of the transdermal opioid dosage (group T). Pain control was equally satisfactory in the two groups. VAS scores at baseline (T: 4.36 ± 1.53; F: 4.51 ± 1.36; n.s.) and at the end of the study (T: 1.8 ± 1.6; F: 1.6 ± 1.5; n.s.) did not differ. However, in the tramadol group this level of pain control was achieved with much slower dose escalation of fentanyl. The mean application time of the fentanyl-Transdermal Therapeutic System patch for each dosage (25, 50, 75 ,g/hour) was significantly greater in patients receiving tramadol. No patient in group T escalated to the 100 ,g/hour patch, while in 12 patients of group F the 100 ,g/hour patch was applied after a 75 ,g/hour patch mean application period of 18.6 ± 4.7 days. The number of fentanyl-TTS dosage changes was significantly lower in group T (1.2 ± 0.4 vs. 2.3 ± 0.5; P < 0.05). The mean total duration of treatment in group T, was 37.1 ± 11.6 days. The amount of fentanyl used at study end was 56.6 ± 11.2 ,g/hour plus 141.1 ± 151.9 mg tramadol per day (median: 200 mg/day) in group T patients compared with 84.1 ± 12.2 ,g/hour in group F patients (P < 0.05). The combination of a strong opioid with a weak opioid to treat severe cancer pain allowed a more gradual increase of analgesic delivery than was possible using fentanyl-TTS alone, minimizing periods of under- and overdosing. In addition, it considerably slowed the pace of fentanyl dose escalation. In conclusion, this TTS fentanyl-tramadol analgesic protocol provides a useful alternative to the usual treatment of cancer pain with fentanyl-TTS alone, especially in case of quick progression of disease and pain.,, [source] Tramadol for pain relief in children undergoing herniotomy: a comparison with ilioinguinal and iliohypogastric blocksPEDIATRIC ANESTHESIA, Issue 1 2006MOHAMMAD BAGHER KHOSRAVI MD Summary Background:, Prevention of postoperative pain in children is one of the most important objectives of the anesthesiologist. Preoperative ilioinguinal and iliohypogastric nerve blocks have been widely used to provide analgesia in children undergoing herniorrhaphy. Tramadol is an analgesic with micro-opioid and nonopioid activity. In this study we compared the usage of intravenous tramadol with ilioinguinal and iliohypogastric nerve blocks for control of postherniorrhaphy pain in children aged 2,7 years. Methods:, Sixty patients were randomly allocated to two groups of thirty. One group received tramadol 1.5 mg·kg,1 i.v. before induction of general anesthesia and the other had an ilioinguinal and iliohypogastric nerve block with 0.5% bupivacaine (0.25 ml·kg,1) before skin incision. We assessed pain using the Children's Hospital of Eastern Ontario Pain Scale and the Categorical Pain Scale. Results:, At 1, 4 and 24 h after surgery the two groups had identical pain scores. At 2 and 3 h after surgery the tramadol group experienced significantly less pain (P < 0.05). The rescue drug for residual pain, was used equally in the two groups. None of the 60 patients had respiratory depression but the tramadol group patients were found to have more episodes of nausea and vomiting (P < 0.05). Conclusions:, We concluded that tramadol can have at least the same analgesic effect as that of ilioinguinal and iliohypogastric nerve blocks for postherniorrhaphy pain in children, with even a superior effect at the time of maximal analgesia. We also highlight the troublesome side-effect of nausea and vomiting which brings into question the benefits of using this opioid that seems to lack respiratory depression. [source] Tramadol for pain relief in children undergoing tonsillectomy: a comparison with morphinePEDIATRIC ANESTHESIA, Issue 3 2003Thomas Engelhardt MD SummaryBackground: Pain control for paediatric patients undergoing tonsillectomy remains problematic. Tramadol is reported to be an effective analgesic and to have a side-effect profile similar to morphine, but is currently not licensed for paediatric use in the UK. Methods: We conducted a prospective, double-blind, randomized controlled trial in children who were scheduled for elective tonsillectomy or adenotonsillectomy at the Royal Aberdeen Children Hospital. Following local ethics committee approval and after obtaining a drug exemption certificate from the Medicines Licensing Agency for an unlicensed drug, we recruited 20 patients each into morphine (0.1 mg·kg,1), tramadol (1 mg·kg,1) and tramadol (2 mg·kg,1) groups. These drugs were given as a single injection following induction of anaesthesia. In addition, all patients received diclofenac (1 mg·kg,1) rectally. The postoperative pain scores, analgesic requirements, sedation scores, signs of respiratory depression and nausea and vomiting, as well as antiemetic requirements, were noted at 4-h intervals until discharge. Results: There were no statistically significant differences in age, weight, type of operation or induction of anaesthesia, 4-h sedation and pain scores and further analgesic requirements. There were no episodes of respiratory depression. Morphine was associated with a significantly higher incidence of vomiting following discharge to the wards (75% versus 40%, P=0.03) compared with both tramadol groups. Conclusions: Tramadol has similar analgesic properties, when compared with morphine. The various pharmaceutical presentations and the availability as a noncontrolled substance may make it a useful addition to paediatric anaesthesia if it becomes licensed for paediatric anaesthesia in the UK. [source] New guideline for tramadol usage following adverse drug reactions reported to the Iranian pharmacovigilance center,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 2 2007K. Gholami Pharm D Abstract Background Tramadol was introduced as injection and oral form to Iranian Pharmaceutical Market in 2002. Shortly after, the injection form of the drug was observed at the top of suspected drug list of Adverse Drug Reactions (ADRs) received monthly by Iranian Pharmacovigilance Center (IPC). Objectives To detect, assess and report total number of Tramadol-induced ADRs received by IPC. To assess the frequency of reported Tramadol-induced ADRs before and after interventions. To design a guideline for prevention of probable ADRs due to Tramadol injection. Methods A descriptive study was conducted on spontaneous reporting received by IPC from April 2002 to February 2005. All ADRs suspected to be induced by Tramadol registered in the database during mentioned period were analysed. To assess the effect of different interventions based on Spontaneous Reporting System, the trend of reporting frequency of Tramadol-induced ADRs was evaluated before and after interventions. Results There were 337 cases of Tramadol-induced ADRs describing 939 reactions, reported to IPC during the study period. Although causal relationship had not been established, three cases of deaths appeared among the reports. The severity of reactions led to implementation of limitations on injectable Tramadol distribution to community pharmacies and the restriction of its use to hospitals only. Since most adverse reactions were dose-dependent, the drug potency of injectable Tramadol available in the country changed from 100,mg to 50,mg. The assessment of ADR reports received by IPC showed that the frequency of adverse reactions registered in the centre was reduced considerably following these interventions. Conclusion Designing a detailed programme by Pharmacovigilance Centres and closely monitoring of newly marketed pharmaceutical products is highly recommended. Copyright © 2006 John Wiley & Sons, Ltd. [source] Evaluation of tramadol and its main metabolites in horse plasma by high-performance liquid chromatography/fluorescence and liquid chromatography/electrospray ionization tandem mass spectrometry techniquesRAPID COMMUNICATIONS IN MASS SPECTROMETRY, Issue 2 2009Marinella De Leo Tramadol is a centrally acting analgesic drug that has been used clinically for the last two decades to treat pain in humans. The clinical response of tramadol is strictly correlated to its metabolism, because of the different analgesic activity of its metabolites. O -Desmethyltramadol (M1), its major active metabolite, is 200 times more potent at the µ -receptor than the parent drug. In recent years tramadol has been widely introduced in veterinary medicine but its use has been questioned in some species. The aim of the present study was to develop a new sensible method to detect the whole metabolic profile of the drug in horses, through plasma analyses by high-performance liquid chromatography (HPLC) coupled with fluorimetric (FL) and photodiode array electrospray ionization mass spectrometric (PDA-ESI-MS) detection, after its sustained release by oral administration (5,mg/kg). In HPLC/FL experiments the comparison of the horse plasma chromatogram profile with that of a standard mixture suggested the identification of the major peaks as tramadol and its metabolites M1 and N,O -desmethyltramadol (M5). LC/PDA-ESI-MS/MS analysis confirmed the results obtained by HPLC/FL and also provided the identification of two more metabolites, N -desmethyltramadol (M2), and N,N -didesmethyltramadol (M3). Another metabolite, M6, was also detected and identified. The present findings demonstrate the usefulness and the advantage of LC/ESI-MS/MS techniques in a search for tramadol metabolites in horse plasma samples. Copyright © 2008 John Wiley & Sons, Ltd. [source] Tramadol versus Buprenorphine for the Management of Acute Heroin Withdrawal: A Retrospective Matched Cohort Controlled StudyTHE AMERICAN JOURNAL ON ADDICTIONS, Issue 2 2006Threlkeld Threlkeld MD Many medications have been used over the past thirty years for the treatment of opioid withdrawal, including propoxyphene, methadone, clonidine, parenteral buprenorphine, and, more recently, sublingual buprenorphine. Each has been found to have clinical strengths and limitations. Tramadol is a centrally acting synthetic analgesic with opiate activity primarily due to the binding ofa metabolite to the , receptor. Despite this , receptor activity, tramadol appears to have low abuse potential and is a non-scheduled analgesic. The pharmacologic profile of tramadol makes it a candidate for opiate withdrawal treatment. A chart review was undertaken to retrospectively compare treatment outcomes of heroin-dependent patients when detoxified with parenteral buprenorphine (1996,1997) versus tramadol (1999,2000). Inclusion criteria for this study were heroin as drug of choice, current opioid physical dependence (ie, withdrawal symptoms), no current abuse of oral opioid analgesics, and no alcohol or benzodiazepine withdrawal symptoms. Patient cases that met inclusion criteria were group-matched between buprenorphine and tramadol on the basis of age, sex, and amount of heroin used (bags/ day). Charts were audited for patient demographics, daily heroin use at admission, withdrawal symptoms, and discharge status. In total, 129 patient charts were reviewed, and 115 met all inclusion criteria and were group-matched (45 patients in the buprenorphine group, seventy in the tramadol group). There were no differences in demographics between the two groups of patients. Fifty-six percent of the buprenorphine group and 71% of the tramadol group completed detoxification; tramadol-treated patients had significantly higher average withdrawal symptoms when compared to the buprenorphine group and a greater reduction in withdrawal symptoms over time. Finally, the number of side effects was small and did not differ between the groups. The results of this study are consistent with previous pilot reports that indicated few clinical differences between parenteral buprenorphine and oral tramadol protocols when used in the management of acute heroin withdrawal. As a consequence, tramadol shows some promise as an opioid withdrawal management medication. [source] ORIGINAL RESEARCH,EJACULATORY DISORDERS: Evaluation of Tramadol on Demand Vs.THE JOURNAL OF SEXUAL MEDICINE, Issue 8 2010Daily Paroxetine as a Long-Term Treatment of Lifelong Premature Ejaculation ABSTRACT Introduction., Premature ejaculation (PE) is the most common male sexual dysfunction with many lines of treatment that show conflicting results. Paroxetine and tramadol were both reported to be effective in treatment of PE. Aim., To investigate the effectiveness of long-term daily paroxetine vs. on-demand tramadol HCl in treatment of PE. Main Outcome Measures., Intravaginal ejaculatory latency time (IELT) and Arabic Index of PE (AIPE) were used to assess the efficacy of investigated drugs. Methods., Thirty-five cases with lifelong PE were enrolled in this study. Baseline recording of IELT using a stop watch and AIPE was done. Patients were randomized to take tramadol HCl on-demand or daily paroxetine. Reassessment was done after 6 and 12 weeks. A wash-out period for 2 weeks was given before cross-over to the other medication. Assessment of the effect of the second medication after 6 and 12 weeks was done. Results., Tramadol and paroxetine increased IELT significantly after 6 weeks by seven- and 11-folds, respectively, compared with baseline. After 12 weeks, a decline of IELT to fivefolds was recorded with tramadol whereas further increase of IELT to 22-folds was recorded with paroxetine compared with baseline (P < 0.05). Tramadol improved AIPE score significantly after 6 weeks but not after 12 weeks vs. baseline, whereas paroxetine increased the AIPE score after 6 and 12 weeks vs. baseline (P < 0.05). Conclusions., Daily paroxetine is more effective than on-demand tramadol for treatment of lifelong PE. Tramadol is not recommended as a long-term treatment of lifelong PE. Alghobary M, El-Bayoumy Y, Mostafa Y, E-HM Mahmoud, and Amr M. Evaluation of tramadol on demand vs. daily paroxetine as a long-term treatment of lifelong premature ejaculation. J Sex Med 2010;7:2860,2867. [source] Tramadol for prevention of postanaesthetic shivering: a randomised double-blind comparison with pethidineANAESTHESIA, Issue 2 2009M. Mohta Summary The present study was conducted with the aims of comparing intravenous tramadol 1, 2 and 3 mg.kg,1 with pethidine 0.5 mg.kg,1 for prophylaxis of postanaesthetic shivering and to find a dose of tramadol that could provide the dual advantage of antishivering and analgesic effect in the postoperative period. The study included 165 patients, randomly allocated to five groups of 33 each. Tramadol in doses of 1, 2 and 3 mg.kg,1, pethidine 0.5 mg.kg,1 or normal saline were administered at the time of wound closure. All three doses of tramadol were effective and comparable to pethidine in preventing postanaesthetic shivering. Tramadol 2 mg.kg,1 had the best combination of antishivering and analgesic efficacy without excessive sedation and thus appeared to be a good choice to be administered at the time of wound closure to provide antishivering effect and analgesia without significant side effects in the postoperative period. [source] A comparison of tramadol and pethidine analgesia on the duration of labour: A randomised clinical trialAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 1 2009Maryam KHOOSHIDEH Background: The ideal obstetric analgesia should provide analgesic efficacy without attenuation of uterine contractions. Aims: To compare the outcome of intramuscular administration of pethidine and tramadol in labour analgesia. Methods: One hundred and sixty full-term parturients were randomly assigned to two equal groups in active labour. Group P received 50 mg pethidine; and group T, 100 mg tramadol intramuscularly. Primary outcome measure was the duration of the labour. The analgesic efficacy, maternal side-effects, mode of delivery, maternal satisfaction and Apgar score as the secondary outcome were assessed. Results: The duration of labour was shorter in group T, for first stage (190 vs 140 min; P < 0.0001) and for second stage (33 vs 25 min; P = 0.001). There were no differences in Groups P and T with respect to median (7 vs 8) and maximum (7.5 vs 8) visual analog scores (VAS) for pain at 10 min and one hour after drug administration. Women in group P had lower VAS pain scores than those in group T in the second stage of labour (8 vs 9; P = 0/009). There was a significantly higher incidence of nausea and vomiting (35% vs 15%; P = 0.003) and drowsiness (80% vs 29%; P < 0.0001) in group P. Conclusion: Both 100 mg tramadol and 50 mg pethidine provide moderate analgesia in first stage of labour. Tramadol seems to cause a shorter duration of labour and lower incidence of maternal side-effects. However, its analgesic efficacy was not found to be as effective as pethidine, especially in the second stage of labour. [source] Stereoselective pharmacokinetic analysis of tramadol and its main phase I metabolites in healthy subjects after intravenous and oral administration of racemic tramadolBIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 1 2007Emilio Garcķa Quetglas Abstract The kinetics of tramadol enantiomers are stereoselective when doses of the racemic drug are given orally. To document whether the route of administration determines the stereoselective kinetics of tramadol enantiomers, healthy volunteers received 100 mg oral or intravenous doses of racemic tramadol, and serial blood samples were obtained to assay tramadol enantiomers and their main phase I metabolites, O -demethyltramadol and N -demethyltramadol. To assess accurately the involvement of their metabolites in the pharmacokinetics of tramadol, it is essential to determine the rate and extent of the formation of the enantiomers of these metabolites. A simultaneous pharmacokinetic model describing the plasma concentration-curves of the generated metabolites and the parent compounds after intravenous and oral drug administration is developed and presented. Tramadol and O -demethyltramadol were the major compounds detected in plasma after intravenous administration. Nevertheless, the N -demethylation of tramadol showed a significant increase when the oral route was used. After both oral and intravenous doses, the kinetics of the tramadol enantiomers were stereoselective. The AUC for (R )-(+)-tramadol was greater than the AUC for (S)-(,)-tramadol. The formation of N -demethyltramadol also was enantioselective after oral administration of racemic tramadol, with a greater AUC for (R)-(+)- N -demethyltramadol than for (S)-(,)- N -demethyltramadol. In the opposite form, (S)-(,)- O -demethyltramadol was formed faster than (R)-(+)- O -demethyltramadol. The metabolism of tramadol was also route-dependent with a different enantiomeric ratio for tramadol and its main phase I metabolites after intravenous and oral administration. The disposition of N -demethyltramadol was concentration-dependent. Copyright © 2006 John Wiley & Sons, Ltd. [source] Safety and efficacy of tramadol in the treatment of idiopathic detrusor overactivity: a double-blind, placebo-controlled, randomized studyBRITISH JOURNAL OF CLINICAL PHARMACOLOGY, Issue 4 2006M. R. Safarinejad Aim To evaluate the efficacy and safety of tramadol in patients with idiopathic detrusor overactivity (IDO). Methods A total of 76 patients 18 years or older with IDO were randomly assigned to receive 100 mg tramadol sustained release (group 1, n = 38) or placebo (group 2, n = 38) every 12 h for 12 weeks. Clinical evaluation was performed at baseline and every 2 weeks during treatment. All patients underwent urodynamics and ice water test at baseline and 12-week treatment. Main outcome measures were number of voids per 24 h, urine volume per void and episodes of urge incontinence per 24 h on a frequency volume chart and detailed recording of adverse effect. Results After 12 weeks of treatment mean number of voids per 24 h ± SD decreased from 9.3 ± 3.2 to 5.1 ± 2.1 (P < 0.001 vs. placebo) [95% confidence interval (CI) ,5.1-,0.4]. At that time mean urine volume per void increased from 158 ± 32 to 198 ± 76 ml (P < 0.001 vs. placebo) (95% CI 8-22), while mean number of incontinence episodes per 24 h decreased from 3.2 ± 3.3 to 1.6 ± 2.8 (P < 0.001 vs. placebo) (95% CI ,2-0.3). Tramadol induced significant improvements in urodynamic parameters. More adverse effects were associated with tramadol treatment than with placebo (P < 0.05). The main adverse event with tramadol was nausea. Conclusions In patients with non-neurogenic IDO tramadol provided beneficial clinical and urodynamic results. Further studies are required to draw final conclusions on the efficacy of this drug in IDO. [source] Critical review of oral drug treatments for diabetic neuropathic pain,clinical outcomes based on efficacy and safety data from placebo-controlled and direct comparative studiesDIABETES/METABOLISM: RESEARCH AND REVIEWS, Issue 3 2005Hugo Adriaensen Abstract The present review aims to evaluate the efficacy and safety of a selection of oral treatments for the management of painful diabetic neuropathy. A literature review was conducted retrieving placebo-controlled and direct comparative studies with a selection of oral treatments for painful diabetic neuropathy. All studies were analyzed with regard to efficacy and tolerability. Efficacy was evaluated as the percentage improvement in pain intensity between baseline and endpoint. Tolerability was evaluated by means of study discontinuations due to adverse events and by incidence of drug-related adverse events. The analyzed trials enrolled different patient populations with mostly small numbers of patients. The great variability in dosages and dose titration schemes, cross-over designs with variable wash-out periods, and other design schemes made comparison between the different studies difficult. Gabapentin, lamotrigine, tramadol, oxycodone, mexiletine, and acetyl-L-carnitine were the only treatments studied in large (at least 100 patients), placebo-controlled parallel group trials. It is concluded that standardization in design and reporting for comparison of treatments is needed. Validated questionnaires for evaluation of the efficacy and safety should be further developed. Based on the reviewed randomised controlled trials, gabapentin shows good efficacy, a favourable side-effect profile with lack of drug interactions and therefore it may be a first choice treatment in painful diabetic neuropathy, especially in the elderly. However, head to head trials of current treatments are lacking and therefore randomized controlled trials are required to address this issue. Copyright © 2005 John Wiley & Sons, Ltd. [source] Options in Prehospital analgesiaEMERGENCY MEDICINE AUSTRALASIA, Issue 1 2002Meredith L Borland Abstract Background: Prehospital analgesia options for paramedics have been limited due to the difficulty in achieving safe and effective pain relief without compromising transportation to hospital. The present paper identifies the analgesia methods currently available in the prehospital setting so as to evaluate the various options and highlight areas for future research. Methods: A literature review of Medline and Embase databases from 1966 until the present was undertaken. Further hand searching of all the references identified in these papers was also performed. All current literature was analysed and categorized according to one of four levels of evidence using National Health and Medical Research Council of Australia guidelines (1999). Results: There is a paucity of randomized control trials relating to prehospital analgesia. All published literature was level III or IV prospective or retrospective studies. Drug options used included nitrous oxide/oxygen mixtures, intravenous/intramuscular nalbuphine, intravenous tramadol and intravenous pure opiate agonists. Conclusions: The evidence supporting analgesic options in the prehospital setting is limited. There are few published data in this area despite the inadequacy of pain relief being recognized as a weakness in prehospital care. Prehospital analgesia is an area worthy of innovative methods for the administration of safe and effective analgesics without significant impact on transport times. Such methods should be prospectively evaluated in well-constructed trials. [source] Dextropropoxyphene withdrawal from a French university hospital: impact on analgesic drug consumptionFUNDAMENTAL & CLINICAL PHARMACOLOGY, Issue 2 2009Sabine Gaubert Abstract Dextropropoxyphene is a weak opioid analgesic, widely used as a step 2 analgesic (according to WHO classification) in combination with peripheral analgesics, mainly paracetamol. Recent data have underlined its poor analgesic efficacy (in comparison with paracetamol), risks of serious adverse drug reactions (i.e. hepatic reactions, hallucinations, abuse, withdrawal symptoms, hypoglycaemia), possible lethality after overdose, its risk of accumulation in patients with renal failure or in elderly people and some pharmacokinetic insufficiencies (i.e. different half-lives for dextropropoxyphene and paracetamol). Taking into account these data, the drug committee of the Toulouse University Hospital (France) decided to withdraw dextropropoxyphene from the hospital formulary since 1 June 2005. The aim of our study was to investigate the consequences of this withdrawal by comparing use of analgesic drugs in Toulouse University Hospital before (2004) and after (2006) dextropropoxyphene withdrawal (using defined daily dose for 1000 hospitalization-days as the unit measure). Before withdrawal, dextropropoxyphene (in combination with paracetamol) was the second most used analgesic drug after paracetamol alone. After dextropropoxyphene withdrawal, total consumption of analgesic drugs decreased by 4.6% (2006 vs. 2004). There was a 28% decrease in consumption of step 2 analgesics [with an increase in oral tramadol and a slight decrease in codeine (in combination with paracetamol)]. During the same period, step 1 analgesic consumption increased by 11% (mainly paracetamol) and that of step 3 analgesics slightly decreased (,8%). These results show that dextropropoxyphene withdrawal was not associated with a marked switch in prescriptions towards other analgesic drugs. This paper underlines the interest of a hospital-based drug committee to promote rational drug use. Finally, the present data allow us to discuss putative misuse of dextropropoxyphene. [source] Persistent Nonmalignant Pain and Analgesic Prescribing Patterns in Elderly Nursing Home ResidentsJOURNAL OF AMERICAN GERIATRICS SOCIETY, Issue 6 2004(See editorial comments by Dr. Debra Weiner on pp 1020, 1022) Objectives: To determine the prevalence of analgesics used, their prescribing patterns, and associations with particular diagnoses and medications in patients with persistent pain. Design: Cross-sectional study. Setting: Nursing homes from 10 U.S. states. Participants: A total of 21,380 nursing home residents aged 65 and older with persistent pain. Measurements: Minimum Data Set (MDS) assessments on pain, analgesics, cognitive, functional, and emotional status were summarized. Logistic regression models identified diagnoses associated with different analgesic classes. Results: Persistent pain as determined using the MDS was identified in 49% of residents with an average age of 83; 83% were female. Persistent pain was prevalent in patients with a history of fractures (62.9%) or surgery (63.6%) in the past 6 months. One-quarter received no analgesics. The most common analgesics were acetaminophen (37.2%), propoxyphene (18.2%), hydrocodone (6.8%), and tramadol (5.4%). Only 46.9% of all analgesics were given as standing doses. Acetaminophen was usually prescribed as needed (65.6%), at doses less than 1,300 mg per day. Nonsteroidal antiinflammatory drugs (NSAIDs) were prescribed as a standing dose more than 70% of the time, and one-third of NSAIDs were prescribed at high doses. Conclusion: In nursing home residents, persistent pain is highly prevalent, there is suboptimal compliance with geriatric prescribing recommendations, and acute pain may be an important contributing source of persistent pain. More effective provider education and research is needed to determine whether treatment of acute pain could prevent persistent pain. [source] Basic pharmacology relevant to drug abuse assessment: tramadol as exampleJOURNAL OF CLINICAL PHARMACY & THERAPEUTICS, Issue 2 2008R. B. Raffa PhD Summary Tramadol is a centrally acting analgesic in widespread use throughout the world. Although there is extensive preclinical, clinical, post-marketing and epidemiological data indicating relatively low , but not zero , abuse/dependence, questions continue to arise about its abuse potential and appropriate regulatory classification. This article considers these questions from the point of view of the basic pharmacology of tramadol. There is nothing unique about tramadol in this regard, but its multimodal mechanism of action, pharmacologically active enantiomers, and active metabolite make it a particularly instructive and relevant example. [source] A Multi-Drug Intoxication Fatality Involving Xyrem® (GHB)JOURNAL OF FORENSIC SCIENCES, Issue 2 2009Brianne E. Akins M.S. Abstract:, Gamma-hydroxybutyrate (GHB) is best known as a recreational depressant drug, whose use has also been implicated in drug facilitated sexual assault cases. It is also available as a therapeutic agent (Xyrem®) used for the treatment of daytime sleepiness or cataplexy associated with narcolepsy. This is a report of a case of a 53-year-old woman undergoing treatment with Xyrem® for narcolepsy. The decedent was also prescribed tramadol, gabapentin, cetirizine, modafinil, carisoprodol, and Xyrem®. Toxicological analysis of the blood revealed GHB 165.6 mg/L, and 90.7 mg/L in the urine. Blood GHB concentrations in the range 156,260 mg/L have been reported to induce moderately sound sleep. The combined use of central nervous system depressant drugs, together with her problematic sleep apnea, and snoring (both contraindications for GHB use) were determined to have caused this subject's death. The manner of death was determined to be accidental. [source] Wound infiltration with magnesium sulphate and ropivacaine mixture reduces postoperative tramadol requirements after radical prostatectomyACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 4 2009P. TAUZIN-FIN Purpose: This prospective, randomized, double-dummy study was undertaken to compare the effects of magnesium sulphate (MgSO4) administered by the intravenous vs. the infiltration route on postoperative pain and analgesic requirements. Methods: Forty ASA I or II men scheduled for radical retropubic prostatectomy under general anaesthesia were randomized into two groups (n=20 each). Two medication sets A and B were prepared at the pharmacy. Each set contained a minibag of 50 ml solution for IV infusion and a syringe of 45 ml for wound infiltration. Group MgSO4.IV patients received set A with 50 mg/kg MgSO4 in the minibag and 190 mg of ropivacaine in the syringe. Group MgSO4/L received set B with isotonic saline in the minibag and 190 mg of ropivacaine +750 mg of MgSO4 in the syringe. The IV infusion was performed over 30 min at induction of anaesthesia and the surgical wound infiltration was performed during closure. Pain was assessed every 4 h, using a 100-point visual analogue scale (VAS). Postoperative analgesia was standardized using IV paracetamol (1 g/6 h) and tramadol was administered via a patient-controlled analgesia system. The follow-up period was 24 h. Results: The total cumulative tramadol consumption was 221 ± 64.1 mg in group MgSO4.IV and 134 ± 74.9 mg in group MgSO4.L (P<0.01). VAS pain scores were equivalent in the two groups throughout the study. No side-effects, due to systemic or local MgSO4 administration, were observed. Conclusion: Co-administration of MgSO4 with ropivacaine for postoperative infiltration analgesia after radical retropubic prostatectomy produces a significant reduction in tramadol requirements. [source] Fracture risk associated with the use of morphine and opiatesJOURNAL OF INTERNAL MEDICINE, Issue 1 2006P. VESTERGAARD Abstract. Objectives., To study the effect of morphine and opiates on fracture risk. Design., Case,control study. Setting., Nationwide register-based study. Subjects., Cases were all subjects with any fracture sustained during the year 2000 (n = 124 655). For each case, three controls (n = 373 962) matched on age and gender were randomly drawn from the background population. The primary exposure variables were use of morphine and opiates. Morphine and other opiates had been used by 10 015 (8.0%) of the case subjects and 12 108 (3.2%) of the controls. Adjustments were made for several confounders including prior fracture, and use of weak analgesics [nonsteroidal anti-inflammatory drugs, acetylsalicylic acid (ASA) and acetaminophene]. The effect of dose was examined by stratifying for cumulated dose (defined daily dose). Main outcome measure., Fracture. Results., Morphine (1.47, 95% CI 1.37,1.58), fentanyl (2.23, 95% CI 1.89,2.64), methadone (1.39, 95% CI 1.05,1.83), oxycodone (1.36, 95% CI 1.08,1.69), nicomorphine (1.57, 95% CI 1.38,1.78), ketobemidone (1.07, 95% CI 1.02,1.13), tramadol (1.54, 95% CI 1.49,1.58) and codeine (1.16, 95% CI 1.12,1.20) were all associated with an increase in overall fracture risk. No increase was present for buprenorphine (0.86, 95% CI 0.79,0.95), pethidine (0.98, 95% CI 0.89,1.08), dextropropoxiphene (1.02, 95% CI 0.90,1.16), and combinations of ASA and codeine (0.94, 95% CI 0.88,1.01). Conclusions., An increased fracture risk is seen in users of morphine and opiates. The reason for this may be related to the risk of falls due to central nervous system effects such as dizziness. [source] Stimulating or conventional perineural catheters after hallux valgus repair: a double-blind, pharmaco-economic evaluationACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 10 2006A. Casati Background:, We prospectively evaluated direct analgesia-related costs of continuous sciatic nerve block using either a stimulating or conventional catheter after hallux valgus repair. Methods:, The perineural catheter was inserted through a stimulating introducer either blindly (group Conventional, n= 38) or while stimulating via the catheter (group Stimulating, n= 38). Nerve block was induced with 25 ml of mepivacaine 15 mg/ml, and was followed 3 h later by a patient-controlled infusion of ropivacaine 2 mg/ml (basal infusion: 3 ml/h; incremental dose: 5 ml; lock-out time: 30 min). Rescue tramadol [100 mg intravenous (i.v.)] was given if required. Local anesthetic consumption, need for rescue tramadol and post-operative nausea and vomiting (PONV) treatment, and patient's satisfaction were recorded during first 24-h infusion. Cost calculations were based on the acquisition cost of drugs and devices. Results:, Both techniques were similarly effective, but local anesthetic consumption and need for rescue analgesics were lower in the Stimulating group [respectively, 120 vs. 153 ml (P= 0.004) and 21% vs. 60% (P= 0.001)]. The analgesia-related costs for 24 h were similar when 100-ml bags of ropivacaine 2 mg/ml were used (66 , vs. 67 ,; P= 0.26). When 200-ml bags of ropivacaine were used, the analgesia-related costs were higher in the Stimulating group than the Conventional group (75 , vs. 55 ,; P= 0.0005). Conclusions:, Direct costs of continuous sciatic nerve block ranged from 55 to 75 ,. Stimulating catheters reduced local anesthetic consumption and need for rescue analgesics. This was only cost effective when 100-ml bags of 2 mg/ml ropivacaine were used, while the cheapest combination was the use of conventional catheters and 200-ml bags of ropivacaine. [source] Treatment of restless legs syndrome: An evidence-based review and implications for clinical practice,,MOVEMENT DISORDERS, Issue 16 2008Claudia Trenkwalder MD Abstract Only in the last three decades, the restless legs syndrome (RLS) has been examined in randomized controlled trials. The Movement Disorder Society (MDS) commissioned a task force to perform an evidence-based review of the medical literature on treatment modalities used to manage patients with RLS. The task force performed a search of the published literature using electronic databases. The therapeutic efficacy of each drug was classified as being either efficacious, likely efficacious, investigational, nonefficacious, or lacking sufficient evidence to classify. Implications for clinical practice were generated based on the levels of evidence and particular features of each modality, such as adverse events. All studies were classed according to three levels of evidence. All Level-I trials were included in the efficacy tables; if no Level-I trials were available then Level-II trials were included or, in the absence of Level-II trials, Level-III studies or case series were included. Only studies published in print or online before December 31, 2006 were included. All studies published after 1996, which attempted to assess RLS augmentation, were reviewed in a separate section. The following drugs are considered efficacious for the treatment of RLS: levodopa, ropinirole, pramipexole, cabergoline, pergolide, and gabapentin. Drugs considered likely efficacious are rotigotine, bromocriptine, oxycodone, carbamazepine, valproic acid, and clonidine. Drugs that are considered investigational are dihydroergocriptine, lisuride, methadone, tramadol, clonazepam, zolpidem, amantadine, and topiramate. Magnesium, folic acid, and exercise are also considered to be investigational. Sumanirole is nonefficacious. Intravenous iron dextran is likely efficacious for the treatment of RLS secondary to end-stage renal disease and investigational in RLS subjects with normal renal function. The efficacy of oral iron is considered investigational; however, its efficacy appears to depend on the iron status of subjects. Cabergoline and pergolide (and possibly lisuride) require special monitoring due to fibrotic complications including cardiac valvulopathy. Special monitoring is required for several other medications based on clinical concerns: opioids (including, but not limited to, oxycodone, methadone and tramadol), due to possible addiction and respiratory depression, and some anticonvulsants (particularly, carbamazepine and valproic acid), due to systemic toxicities. © 2008 Movement Disorder Society [source] Effect of lumbar-epidural administration of tramadol on lower urinary tract function,,NEUROUROLOGY AND URODYNAMICS, Issue 1 2008S.K. Singh Abstract Aims Intrathecal and epidural administration of µ-agonist opioids is associated with urinary retention, a potentially serious adverse-event. In animal studies tramadol has been found not to affect voiding function. We evaluated urodynamic effects of epidural tramadol in humans. Methods Fifteen adults planned for cystoscopy under local-anesthesia underwent urodynamics (UDS) at baseline and 30 min after administration of 100 mg tramadol in lumbar-epidural space. UDS consisted of filling cystometry, pressure-flow study and pelvic floor electromyography (EMG). Subsequently, all underwent cystoscopy and were observed for 6 hr. Results After injection of tramadol, a significant rise was observed in bladder capacity (391.8,±,179.6 ml vs. 432.7,±,208.8 ml; P,=,0.019) and compliance (60.1,±,51.5 ml/cm H2O vs. 83.0,±,63.0 ml/cm H2O; P,=,0.011) without a significant change in filling pressure (22.5,±,13.2 cm H2O vs. 24.1,±,15.1 cm H2O; P,=,0.576). Filling sensations were delayed significantly (P,,,0.05). EMG during filling phase showed a significant fall (P,=,0.027). Peak flow-rate (Qmax), average flow-rate, postvoid residue and detrusor pressure-at-Qmax did not show significant change from baseline (P,>,0.05). Three patients had bladder outlet obstruction which did not worsen after the injection. Guarding reflex was inhibited in seven out of 12 patients who had it at baseline (P,=,0.016). Conclusions Epidural tramadol increases the bladder capacity and compliance and delays filling-sensations, without ill effect on voiding. This seems true even for patients with obstructed outflow; however, due to small number of patients a definite conclusion cannot be derived. These results will guide clinician to avoid catheterization in cases where epidural tramadol is used for postoperative pain. The inhibitory effects of tramadol on EMG activity are intriguing and need further studies. Neurourol. Urodynam. © 2007 Wiley-Liss, Inc. [source] Women with Pain due to Osteoarthritis: The Efficacy and Safety of a Once-Daily Formulation of TramadolPAIN MEDICINE, Issue 6 2009FRCP, Walter F. Kean MB ChB ABSTRACT Objective., This analysis assesses the efficacy and safety of treatment with a once-daily oral formulation of tramadol for up to 12 weeks compared with placebo in women with moderate-to-severe pain due to osteoarthritis of the knee. Design., Two parallel, placebo-controlled phase III clinical trials were analyzed; patients were randomized to a fixed dosage of Tramadol Contramid® once a day (OAD) 100, 200, and 300 mg daily, or placebo. Outcome Measures., The primary efficacy end points were the percentage difference from baseline of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscale scores for pain and physical function, and the patient global rating of pain relief after 12 weeks of maintenance therapy. Results., The analysis included 405 women receiving tramadol and 280 receiving placebo. At week 12, 179 of 204 women (87.7%) receiving tramadol rated their overall pain relief as effective or very effective compared with 134 of 177 (75.7%) receiving placebo. A time-weighted analysis revealed statistically significant improvements over placebo for all the WOMAC subscale scores across all three dosages. The percentage improvements from baseline of the WOMAC pain scores were significantly better than placebo for the 100-mg (58.8 ± 37.1%, P = 0.018) and 300-mg (58.9 ± 38.8%, P = 0.023) treatment arms; however, the 200-mg dosage was not significant (53.0 ± 38.5%, P = 0.175). The WOMAC physical function scores showed significant improvement for the 100 (56.9 ± 36.4%, P = 0.009), 200 (54.0 ± 33.8%, P = 0.034), and 300 mg (53.4 ± 41.4%, P = 0.043) daily dosages. Conclusion., For moderate-to-severe pain due to osteoarthritis of the knee, women experience significant analgesia and improvement of physical function over time with treatment with Tramadol Contramid® OAD. [source] Facial Pain: A Possible Therapy with Stellate Ganglion BlockPAIN MEDICINE, Issue 7 2008Ilaria Salvaggio MD ABSTRACT Objective., The goal of the present study is to verify the efficacy of stellate ganglion block (SGB) in the treatment of facial pain that can be found in different pathological syndromes, and also to examine whether the efficacy is dependent upon when this therapy is administered. Patients., Fifty patients (divided into two randomized groups) with facial pain caused by traumas, iatrogenic issues, herpes zoster, or neurological pathologies participated in this study. Design and Interventions., The first group (N = 25) was treated with SGB produced by 10 administrations of 10 mg of levobupivacaine given every other day, followed by one administration per month for 6 months thereafter. The second group was treated with the drugs tramadol 100 mg/day and gabapentin 1800 mg/day orally for 6 months; during the 7th month they were given SGB therapy using the same methodology as that described for the first group. Results., Before treatment, the mean visual analog scale (VAS) pain score for the first group was 8.89; after the 10th block treatment it was just 0.2, and it remained at that reduced level for the 6th and 12th months. Before treatment, the mean VAS pain score for the second group was 8.83; after the 20th day on medication it was reduced to 4.1, after 6 months it was 5.7 and after 12 months it was 4.9. Conclusions., Our results indicate that patients must be treated with SGB therapy precociously to receive its full benefits. [source] Improved Cancer Pain Treatment Using Combined Fentanyl-TTS and TramadolPAIN PRACTICE, Issue 4 2007Franco Marinangeli MD ,,Abstract: The aim of the study was to facilitate dose escalation of strong opioids. In this randomized open-label study the influence of tramadol on dose adjustment of transdermal fentanyl in advanced cancer pain control was prospectively evaluated. Seventy patients affected by intractable cancer disease with visual analog scale (VAS) score >3 were enrolled. Thirty-five patients were treated conventionally with increasing transdermal fentanyl dosage as required (group F) and 35 patients received oral tramadol added to their transdermal fentanyl before each increment of the transdermal opioid dosage (group T). Pain control was equally satisfactory in the two groups. VAS scores at baseline (T: 4.36 ± 1.53; F: 4.51 ± 1.36; n.s.) and at the end of the study (T: 1.8 ± 1.6; F: 1.6 ± 1.5; n.s.) did not differ. However, in the tramadol group this level of pain control was achieved with much slower dose escalation of fentanyl. The mean application time of the fentanyl-Transdermal Therapeutic System patch for each dosage (25, 50, 75 ,g/hour) was significantly greater in patients receiving tramadol. No patient in group T escalated to the 100 ,g/hour patch, while in 12 patients of group F the 100 ,g/hour patch was applied after a 75 ,g/hour patch mean application period of 18.6 ± 4.7 days. The number of fentanyl-TTS dosage changes was significantly lower in group T (1.2 ± 0.4 vs. 2.3 ± 0.5; P < 0.05). The mean total duration of treatment in group T, was 37.1 ± 11.6 days. The amount of fentanyl used at study end was 56.6 ± 11.2 ,g/hour plus 141.1 ± 151.9 mg tramadol per day (median: 200 mg/day) in group T patients compared with 84.1 ± 12.2 ,g/hour in group F patients (P < 0.05). The combination of a strong opioid with a weak opioid to treat severe cancer pain allowed a more gradual increase of analgesic delivery than was possible using fentanyl-TTS alone, minimizing periods of under- and overdosing. In addition, it considerably slowed the pace of fentanyl dose escalation. In conclusion, this TTS fentanyl-tramadol analgesic protocol provides a useful alternative to the usual treatment of cancer pain with fentanyl-TTS alone, especially in case of quick progression of disease and pain.,, [source] Intraoperative loading attenuates nausea and vomiting of tramadol patient-controlled analgesia. (Show-Chwan Memorial Hospital, Changhua, Taiwan) Can J Anaesth 2000;47:968,973.PAIN PRACTICE, Issue 2 2001Wei-Wu Pang Sixty adult patients scheduled for elective abdominal surgery were enrolled into this prospective, randomized, double-blinded study. The patients were anesthetized in a similar manner. At the beginning of wound closure, the patients were randomly allocated to receive tramadol (Group 1) or normal saline (Group 2). Pain control and adverse effect assessments were done in the PACU and every 6 h for 48 h post drug by an independent observer. The loading dose was 290 ± 45 mg in Group 1 and 315 ± 148 mg in Group 2. In PACU, more nausea and vomiting both in terms of incidence and severity were observed in patients with postoperative loading than in those with intraoperative loading of tramadol. Conclude that administering the loading dose of tramadol during surgery decreases the nausea and vomiting associated with a high dose of tramadol and improves the quality of tramadol PCA in the relief of postoperative pain. Comment by Lian-Kah Ti, M.D. The clinical application and conclusions of this study have to be questioned. It was not surprising that a loading dose of tramadol could effectively be given intraoperatively. What was surprising was that the authors chose not to give any analgesics either preoperatively or intraoperatively for relatively major surgery in an older population, potentially risking morbidity. Indeed, analgesics were withheld in the control group until the patients were extubated, awake, responsive, and complained of pain. Another source of concern was the large loading dose used. Based on their own experience, the authors gave doses of 300 mg of tramadol, which far exceeded the maximum recommended single dose of 100 mg as stated in the manufacturer's instruction for use. The authors did not report any intraoperative hemodynamic consequences from the loading dose, although they noted that the amount of isoflurane required was decreased. The authors concluded that the decreased nausea and vomiting seen in the patients receiving tramadol intraoperatively resulted from the patients being anesthetized at the point when peak plasma levels were achieved. An alternative explanation could be that the patients in the control group had greater postoperative pain (initial VAS of 5.9), and that pain itself resulted in the increased nausea and vomiting. Therefore, the value of this study is doubtful. [source] Efficacy of bupivacaine-neostigmine and bupivacaine-tramadol in caudal block in pediatric inguinal herniorrhaphyPEDIATRIC ANESTHESIA, Issue 9 2010REZA TAHERI MD Summary Background:, Limited duration of analgesia is among the limitations of single caudal injection with local anesthetics. Therefore, the purpose of this study was to evaluate the effectiveness and safety of bupivacaine in combination with either neostigmine or tramadol for caudal block in children undergoing inguinal herniorrhaphy. Methods:, In a double-blinded randomized trial, sixty children undergoing inguinal herniorrhaphy were enrolled to receive a caudal block with either 0.25% bupivacaine (1 ml·kg,1) with neostigmine (2 ,g·kg,1) (group BN) or tramadol (1 mg·kg,1) (group BT). Hemodynamic variables, pain and sedation scores, additional analgesic requirements, and side effects were compared between two groups. Results:, Duration of analgesia was longer in group BT (17.30 ± 8.24 h) compared with group BN (13.98 ± 10.03 h) (P = 0.03). Total consumption of rescue analgesic was significantly lower in group BT compared with group BN (P = 0.04). There were no significant differences in heart rate, mean arterial pressure, and oxygen saturation between groups. Adverse effects excluding the vomiting were not observed in any patients. Conclusion:, In conclusion, tramadol (1 mg·kg,1) compared with neostigmine (2 ,g·kg,1) might provide both prolonged duration of analgesia and extended time to first analgesic in caudal block. [source] | ||||||||||||||||||||||||||||||||||