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Sedation Scores (sedation + score)
Selected AbstractsEffect of midazolam on memory: a study of process dissociation procedure and functional magnetic resonance imagingANAESTHESIA, Issue 6 2010S. Y. Tian Summary To assess the effects of midazolam on explicit and implicit memories, 12 volunteers were randomly divided into the two groups: one with an Observer's Assessment of Alertness/Sedation score of 3 (mild sedation) and one with a score of 1 (deep sedation). Blood oxygen-level-dependent functional magnetic resonance imaging was measured before and during an auditory stimulus, then with midazolam sedation, and then during a second auditory stimulus with continuous midazolam sedation. After 4 h, explicit and implicit memories were assessed. There was no evidence of explicit memory at the two levels of midazolam sedation. Implicit memory was retained at a mild level of midazolam sedation but absent at a deep level of midazolam sedation. At a mild level of midazolam sedation, activation of all brain areas by auditory stimulus (as measured by functional magnetic resonance imaging) was uninhibited. However, a deep level of midazolam sedation depressed activation of the superior temporal gyrus by auditory stimulus. We conclude that midazolam does not abolish implicit memory at a mild sedation level, but can abolish both explicit and implicit memories at a deep sedation level. The superior temporal gyrus may be one of the target areas. [source] A comparison of dexmedetomidine and midazolam for sedation in third molar surgery,ANAESTHESIA, Issue 11 2007C. W. Cheung Summary This randomised, double-blind study compared dexmedetomidine and midazolam for intravenous sedation during third molar surgery under local anaesthesia. Sixty patients received either dexmedetomidine (up to 1 ,g.kg,1) or midazolam (up to 5 mg), which was infused until the Ramsay Sedation Score was four or the maximum dose limit was reached. Intra-operative vital signs, postoperative pain scores and analgesic consumption, amnesia, and satisfaction scores for patients and surgeons, were recorded. Sedation was achieved by median (IQR (range)) doses of 47 ,g (39,52 (25,76)) or 0.88 ,g.kg,1 (0.75,1.0 (0.6,1.0)) dexmedetomidine, and 3.6 mg (3.3,4.4 (1.9,5.0)) or 0.07 mg.kg,1 (0.055,0.085 (0.017,0.12)) midazolam. Heart rate and blood pressure during surgery were lower in dexmedetomidine group. There was no significant difference in satisfaction or pain scores. Midazolam was associated with greater amnesia. Dexmedetomidine produces comparable sedation to midazolam. [source] Does pethidine affect the cardiovascular and sedative effects of dexmedetomidine in dogs?JOURNAL OF SMALL ANIMAL PRACTICE, Issue 2 2009N. J. Grint Objectives: To investigate pethidine's effects on sedation and cardiovascular variables in dogs premedicated with dexmedetomidine. Methods: Sixty American Society of Anesthesiologists (ASA) I dogs were presented for routine neutering. Heart rate was measured at admission. Dogs were randomly assigned to one of the five groups to decide premedication; group D5+P (dexmedetomidine 5 ,g/kg plus pethidine 5 mg/kg), D10+P (dexmedetomidine 10 ,g/kg plus pethidine 5 mg/kg) with three control groups, D5 (dexmedetomidine 5 ,g/kg), D10 (dexmedetomidine 10 ,g/kg) or P (pethidine 5 mg/kg). Heart rate was measured at 3, 5, 10 and 20 minutes after preanaesthetic medication. Simple descriptive scores for sedation were assigned after 20 minutes. Anaesthesia was induced using propofol and maintained using isoflurane in oxygen. Heart rate was recorded throughout anaesthesia. Results: Sedation scores after preanaesthetic medication were significantly higher (P<0·001) in groups D5+P and D10+P compared with the other three groups. D5+P and D10+P groups tended to have lower heart rates in dogs at all time points after premedication compared with groups containing only pethidine or dexmedetomidine at the relevant dose. Clinical Significance: Greater sedation is achieved using combinations of dexmedetomidine and pethidine compared with each drug alone. Pethidine does not attenuate the alpha-2 adrenergic-induced bradycardia. [source] An acute pain service improves postoperative pain management for children undergoing selective dorsal rhizotomyPEDIATRIC ANESTHESIA, Issue 12 2009CHANTAL FRIGON MSC MD Summary Background:, A continuous epidural infusion of morphine is the pain treatment modality for children undergoing selective dorsal rhizotomy (SDR) in our institution. The aim of the study was to evaluate the impact of having an organized acute pain service (APS) on postoperative pain management of these children. Methods:, We conducted a retrospective cohort study using anesthetic records and the APS database to compare the postoperative pain management of children undergoing SDR before and after the introduction of the APS at the Montreal Children's Hospital in April 2001. Ninety-two consecutive children who had their surgery between January 1997 and July 2006 were included. We collected data regarding postoperative pain, opioid-induced side effects, complications (sedation, desaturations < 92%), and hospital length of stay. Results:, Pain scores were documented more frequently after the implementation of the APS (61% vs 48.5%). Sedation scores were documented only after the implementation of the APS. Postoperative desaturation was significantly more frequent in the pre-APS group compared to the APS group (45.5% vs 6.8%, P < 0.001). Despite the fact that the epidural catheter was in place for the same duration for both groups [median of 3 days (3,3 25,75%ile)], the duration of hospitalization was 1 day shorter in the APS group compared to the pre-APS group [median of 5 (5,5 25,75%ile) vs 6 (5,6 25,75%ile) days, P < 0.001]. Conclusions:, Although we recognize that it is possible that there were changes in care not related specifically to the introduction of a dedicated APS that occurred in our institution that resulted in improvements in general postoperative care and in length of stay, our study did show that having an organized APS allowed to significantly decrease the incidence of postoperative oxygen desaturation and to decrease the hospital length of stay by 1 day. [source] Does propofol and alfentanil-induced sedation cause periodic apnoea in chronic renal failure patients?INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 1 2010S. M. Lee Summary Aims:, There is evidence suggesting that the respiratory response to sedation is different in patients with sleep apnoea, which is common in patients with chronic renal failure (CRF). This study examined the respiratory response of sedation with propofol and alfentanil, whose pharmacokinetics are not affected by the renal function, in CRF patients. Methods:, Chronic renal failure patients who underwent arteriovenous-fistular surgery (CRF group) and patients who underwent chemoport insertion (control group) were enrolled in this study. Sedation was induced by infusing propofol 1.5 ,/ml and alfentanil 0.2 ,/kg/min continuously in both groups. In the desaturation study, the respiratory rate and peripheral oxygen saturation in room air were checked. In the apnoea,hypopnoea study, the patient's sedation (Observer's Assessment of Alertness/Sedation) score, apnoea,hypopnoea index (AHI) was recorded using a portable ventilation effort recorder (microMesam) while applying 5 l/min of oxygen through a facial mask. Results:, The desaturation event was more common (21.5/h vs. 2/h, p = 0.001) in the CRF patients. Apnoea and hypopnoea (AHI: 13.0 vs. 1.6, p = 0.012, per cent of patients with an AHI > 5: 53.3% vs. 7.1%, p = 0.014) occurred more frequently in the CRF patients but the sedation score was not different. Conclusion:, Chronic renal failure patients have a higher risk of developing apnoea and hypopnoea during sedation, which highlights the need for careful monitoring and management in these patients. [source] Effect of dexmedetomidine on the characteristics of bupivacaine in a caudal block in pediatricsACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 2 2009I. SAADAWY Background: Dexmedetomidine (DEX) is a highly selective ,2 -adrenoceptor agonist that has been used increasingly in children. However, the effect of caudal DEX has not been evaluated before in children. This prospective randomized double-blinded study was designed to evaluate the analgesic efficacy of caudal DEX with bupivacaine in providing pain relief over a 24-h period. Methods: Sixty children (ASA status I) aged 1,6 years undergoing unilateral inguinal hernia repair/orchidopexy were allocated randomly to two groups (n=30 each). Group B received a caudal injection of bupivacaine 2.5 mg/ml, 1 ml/kg; Group BD received the same dose of bupivacaine mixed with DEX 1 ,g/kg during sevoflurane anesthesia. Processed electroencephalogram (bispectral index score), heart rate, blood pressure, pulse oximetry and end-tidal sevoflurane were recorded every 5 min. The characteristics of emergence, objective pain score, sedation score and quality of sleep were recorded post-operatively. Duration of analgesia and requirement for additional analgesics were noted. Results: The end-tidal sevoflurane concentration and the incidence of agitation were significantly lower in the BD group (P<0.05). The duration of analgesia was significantly longer (P<0.001) and the total consumption of rescue analgesic was significantly lower in Group BD compared with Group B (P<0.01). There was no statistically significant difference in hemodynamics between both groups. However, group BD had better quality of sleep and a prolonged duration of sedation (P<0.05). Conclusion: Caudal DEX seems to be a promising adjunct to provide excellent analgesia without side effects over a 24-h period. It has the advantage of keeping the patients calm for a prolonged time. Implications statement: Caudally administered DEX (1 ,g/kg), combined with bupivacaine, was associated with an extended duration of post-operative pain relief. [source] Midazolam as a sole sedative for computed tomography imaging in pediatric patientsPEDIATRIC ANESTHESIA, Issue 9 2009RANJU SINGH MD Summary Objective:, To evaluate the efficacy and adverse effects of i.v. midazolam as a sole agent for sedation in children for computed tomography (CT) imaging. Materials and Methods:, Prospective clinical trial in which 516 children under ASA classification II,IV (273 boys and 243 girls) in the age group of 6 months to 6 years for elective CT scan were enrolled over a 17-month period. Patients were administered i.v. midazolam 0.2 mg·kg,1 and further boluses of 0.1 mg·kg,1 (total 0.5 mg·kg,1) if required. Measurements included induction time, efficacy, side effects, complications, and degree of sedation. Sedation was graded on the basis of Ramsay sedation score (RSS) as over sedated (RSS 5,6), adequately sedated (AS, RSS 3,4), under sedated (RSS 1,2), or failed if the procedure could not be completed or another agent had to be administered. Results:, Of the 516 procedures, 483 brains, 16 chests, and 17 abdomens were scanned with a mean duration of 4.75 ± 1.75 min with a mean dose of 0.212 mg·kg,1 of i.v. midazolam. Four hundred and sixty-five (90.12%) patients were AS in 5.9 ± 0.7 min while 40 (7.75%) patients required additional boluses. Of these 40 patients, 24 (4.65%) required a single bolus, 12 (2.32%) required two boluses, whereas the remaining four (0.78%) required three boluses. In 11 (2.13%; P < 0.0001) patients, the scan could not be completed satisfactorily. Side effects were seen in 46 (9.11%) patients in the form of desaturation, hiccups (seven patients, 1.38%), and agitation (four patients, 0.79%). Desaturation (SpO2 90,95%) was seen in 35 (6.93%) patients, which was corrected by topical application of oxygen. None of the patients exhibited any complications such as pulmonary aspiration or need to maintain airway. The patients were kept under observation for 1 h after the procedure. Conclusion:, The level of sedation achieved in children with midazolam 0.2 mg·kg,1 is adequate for imaging with minimal side effects, no airway complications, and fast recovery. It can be recommended as the sole agent for sedation in pediatric patients for CT imaging. [source] The efficacy of intravenous or peritonsillar infiltration of ketamine for postoperative pain relief in children following adenotonsillectomy,PEDIATRIC ANESTHESIA, Issue 3 2007DIDEM DAL MD Summary Background :,A few previous studies have suggested the efficacy of i.v. ketamine for postoperative pain relief in children after adenotonsillectomy, but none has investigated the efficacy of peritonsillar infiltration of ketamine in these children. Methods :,This randomized, placebo-controlled study evaluated the effects of peritonsillar infiltration of ketamine in children undergoing adenotonsillectomy. Ninety ASA I-II children were randomized three groups of 30 each. Group I received: 2 ml i.v. saline, group II received i.v. ketamine (0.5 mg·kg,1) and group III received a local peritonsillar infiltration of ketamine (0.5 mg·kg,1). All medications were 2 ml in volume which was applied 1 ml per tonsil 3 min prior to tonsillectomy. Modified Hannallah pain scale [observational pain scores (OPS)], nausea, vomiting, bleeding, rescue analgesia, sedation and Aldrete scores were recorded at first, 15th, 30th and 60th min postoperatively. Patients were interviewed on the day after surgery to assess the postoperative pain, nightmares, hallucinations, vomiting and bleeding. Results :,Group I had higher OPS scores than group II and group III. Group II and group III had comparable scores, which were not statistically significant (P > 0.05). Group II had higher sedation score at 15th min (P = 0.015). Thirty-two children, 19 of whom were in group I had rescue analgesia in postanesthesia care unit (P < 0.05) and the time to first analgesic requirement was significantly shorter in group I than the other groups (P = 0.006). Group II and group III also had less pain than group I at home (P = 0.023). Conclusions :,Low dose ketamine given i.v. or by peritonsillar infiltration perioperatively provides efficient pain relief without side-effects in children undergoing adenotonsillectomy. [source] Comparison of effects and plasma concentrations of opioids between elderly and middle-aged patients after cardiac surgeryACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 1 2009A. PESONEN Background: In elderly patients, opioids may cause prominent postoperative sedation and respiratory depression. We evaluated the influence of age on the effects of opioids and plasma concentrations of fentanyl and oxycodone in cardiac surgery patients. Methods: Thirty (,75 years, gender M9/F21) and 20 (,60 years, gender M20/F0) patients scheduled to undergo cardiac surgery. A standard anesthesia with fentanyl as an opioid was used. Fentanyl plasma concentrations were measured at the end of surgery and 2 h later. After tracheal extubation, when the pain intensity was at least moderate, blood samples for fentanyl and oxycodone plasma concentration measurements were taken. Thereafter, oxycodone hydrochloride 0.05 mg/kg i.v. was administered. After 15 and 45 min, pain intensity, sedation and oxycodone plasma concentration were determined. This test protocol was repeated twice. Results: The elderly had a higher plasma concentration of fentanyl at the end of surgery than younger patients (5.7±2.2 vs. 3.8±1.2 ng/ml, P=0.001). The plasma concentrations of oxycodone were comparable between the groups. The interval between the second and the third oxycodone dose was longer in the elderly patients (P=0.036). Pain intensity on the verbal rating scale was lower at the 45-min assessment point after all three oxycodone test doses (P=0.008) and sedation scores were significantly higher after the third dose in the elderly patients (P=0.035). Conclusions: In elderly patients, the plasma concentration of fentanyl was higher but plasma levels of oxycodone were at a similar level compared with middle-aged patients. However, the elderly patients had less pain and were more sedated after doses of oxycodone. [source] Pharmacokinetic profile and behavioral effects of gabapentin in the horseJOURNAL OF VETERINARY PHARMACOLOGY & THERAPEUTICS, Issue 5 2010R. L. TERRY Terry, R. L., McDonnell, S. M., van Eps, A. W., Soma, L. R., Liu, Y., Uboh, C. E., Moate, P. J., Driessen, B. Pharmacokinetic profile and behavioral effects of gabapentin in the horse. J. vet. Pharmacol. Therap. 33, 485,494. Gabapentin is being used in horses although its pharmacokinetic (PK) profile, pharmacodynamic (PD) effects and safety in the equine are not fully investigated. Therefore, we characterized PKs and cardiovascular and behavioral effects of gabapentin in horses. Gabapentin (20 mg/kg) was administered i.v. or p.o. to six horses using a randomized crossover design. Plasma gabapentin concentrations were measured in samples collected 0,48 h postadministration employing liquid chromatography-tandem mass spectrometry. Blood pressures, ECG, and sedation scores were recorded before and for 12 h after gabapentin dosage. Nineteen quantitative measures of behaviors were evaluated. After i.v. gabapentin, the decline in plasma drug concentration over time was best described by a 3-compartment mammillary model. Terminal elimination half-life (t1/2,) was 8.5 (7.1,13.3) h. After p.o. gabapentin terminal elimination half-life () was 7.7 (6.7,11.9) h. The mean oral bioavailability of gabapentin (±SD) was 16.2 ± 2.8% indicating relatively poor absorption of gabapentin following oral administration in horses. Gabapentin caused a significant increase in sedation scores for 1 h after i.v. dose only (P < 0.05). Among behaviors, drinking frequency was greater and standing rest duration was lower with i.v. gabapentin (P < 0.05). Horses tolerated both i.v. and p.o. gabapentin doses well. There were no significant differences in and . Oral administration yielded much lower plasma concentrations because of low bioavailability. [source] Auditing sedation scores: what is the best way to present the data?ACTA ANAESTHESIOLOGICA SCANDINAVICA, Issue 10 2005S. Mohan No abstract is available for this article. [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] Propofol,ketamine vs propofol,fentanyl combinations for deep sedation and analgesia in pediatric patients undergoing burn dressing changes,PEDIATRIC ANESTHESIA, Issue 1 2008ZEYNEP TOSUN MD Summary Background:, The aim of this study was to compare propofol,ketamine (PK) and propofol,fentanyl (PF) combinations for deep sedation and analgesia in pediatric burn wound dressing changes. Methods:, Thirty-two ASA physical status II and III inpatients with a second degree total burn surface area ranging from 5% to 25% were studied in a randomized, double blind fashion. Heart rate, systolic arterial pressure, peripheral oxygen saturation, respiratory rate and Ramsey sedation scores of all patients were recorded perioperatively. Patients were randomly assigned to receive either PK or PF: PK group (n = 17) received 1 mg·kg,1 ketamine + 1.2 mg·kg,1 propofol, and PF group (n = 15) received 1 ,g·kg,1 fentanyl + 1.2 mg·kg,1 propofol for induction. Additional propofol (0.5,1 mg·kg,1) was administered when the patients showed discomfort in both groups. If the patient showed discomfort and/or increase in heart rate or systolic arterial pressure, despite additional propofol dose, additional bolus of 0.5,1 mg·kg,1 ketamine or 0.5,1 ,g·kg,1 fentanyl was administered. Results:, There were no significant differences in heart rate, systolic arterial pressure, peripheral oxygen saturation, respiratory rate and sedation scores during the procedure between the groups. Restlessness during the procedure was seen in seven (47%) patients in Group PF and one (5.9%) patient in Group PK (P = 0.013). Conclusions:, Both propofol,ketamine and propofol,fentanyl combinations provided effective sedation and analgesia during dressing changes in pediatric burn patients. But propofol,ketamine combination was superior to propofol,fentanyl combination because of more restlessness in patients given propofol,fentanyl. [source] Pentobarbital vs chloral hydrate for sedation of children undergoing MRI: efficacy and recovery characteristicsPEDIATRIC ANESTHESIA, Issue 7 2004Shobha Malviya MD Summary Background :,Chloral hydrate (CH) sedation for magnetic resonance imaging (MRI) is associated with significant failure rates, adverse events and delayed recovery. Pentobarbital (PB), reportedly produces successful sedation in 98% of children undergoing diagnostic imaging. This study compared the efficacy, adverse events and recovery characteristics of CH vs PB in children undergoing MRI. Methods :,With Institutional Review Board approval and written consent, children were randomly assigned to receive intravenous (i.v.) PB (maximum 5 mg·kg,1 in incremental doses) or oral CH (75 mg·kg,1) prior to MRI. Sedation was augmented with 0.05 mg·kg,1 doses of i.v. midazolam (maximum 0.1 mg·kg,1) as necessary. Adverse effects, including hypoxaemia, failed sedation, paradoxical reactions and behavioural changes, the return of baseline activity, and parental satisfaction were documented. The quality of MRI scans was evaluated by a radiologist blinded to the sedation technique. Results :,PB facilitated an earlier onset of sedation (P = 0.001), higher sedation scores (P = 0.01), and less need for supplemental midazolam compared with CH. Severe hypoxaemia occurred in two children (6%) in the PB group. Fourteen per cent of the PB group experienced a paradoxical reaction, 9% sedation failure and 11% major motion artefact, compared with 0% (P = 0.05), 3 and 2% (P = NS), respectively, in the CH group. CH and PB were both associated with a high incidence of motor imbalance, and agitation. However, children who received PB had a slower return to baseline activity (P = 0.04). Conclusions :,Although PB facilitated a quicker sedation onset and reduced the requirement for supplemental sedation, it produced a higher incidence of paradoxical reaction and prolonged recovery with a similar failure rate compared with CH. [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] Evaluation of a new method of assessing depth of sedation using two-choice visual reaction time testing on a mobile phone,ANAESTHESIA, Issue 1 2009A. J. Thomson Summary The utility of two-choice visual reaction time testing using a specially programmed mobile telephone as a measure of sedation level was investigated in 20 healthy patients sedated with target controlled infusions of propofol. At gradually increasing target concentrations visual reaction time was compared with patient-assessed visual analogue scale sedation scores and an observer-rated scale. Propofol sedation caused dose-dependent increases in visual reaction time and visual analogue scale scores that were statistically significant when the calculated effect-site concentration reached 0.9 ,g.ml,1 (p < 0.05) and 0.5 ,g.ml,1 (p < 0.01) respectively. While visual analogue scale scores were more sensitive at lower levels of sedation than visual reaction time, the latter demonstrated marked increase in values at higher levels of sedation. Visual reaction time may be useful for identifying impending over-sedation. [source] Ondansetron versus Promethazine to Treat Acute Undifferentiated Nausea in the Emergency Department: A Randomized, Double-blind, Noninferiority TrialACADEMIC EMERGENCY MEDICINE, Issue 3 2008Darren Braude MD Abstract Objectives:, The authors sought to compare ondansetron and promethazine among emergency department (ED) patients with undifferentiated nausea. The hypothesis was that ondansetron was not inferior to promethazine and that rates of adverse effects were similar. Methods:, This was a randomized double-blind noninferiority clinical trial conducted in an urban academic ED. A convenience sample of nonpregnant adults with at least 40 mm of self-reported nausea measured on a 100-mm visual analog scale (VAS) were enrolled. Patients who had already received more than 1 L of intravenous fluid or an antiemetic agent were excluded. Subjects were block-randomized in groups of 10 to either 4 mg of ondansetron or 25 mg of promethazine delivered intravenously. The primary outcome was change in nausea over 30 minutes. The authors used a 15-mm margin of noninferiority. Secondary endpoints included changes in anxiety, sedation, and other adverse effects. Analyses included t-tests, tests for proportions, and 95% confidence intervals (CIs). Results:, A total of 120 subjects completed the study, 60 in each arm. Baseline nausea, anxiety, and sedation scores were similar. Ondansetron and promethazine reduced nausea similarly (ondansetron ,34 mm, promethazine ,36 mm; difference ,2 mm; 95% CI = ,13 to 8 mm). The reduction in anxiety was similar (ondansetron ,13 mm, promethazine ,14 mm; difference ,1 mm; 95% CI = ,10 to 10 mm). Promethazine was associated with significantly more sedation than ondansetron (ondansetron 5 mm, promethazine 19 mm; difference 14 mm; 95% CI = 5 to 24 mm). There were no cases of akathisia in the ondansetron group and 2 cases in the promethazine group. Conclusions:, Promethazine and ondansetron have similar efficacy in reducing nausea among ED patients. Change in anxiety was similar, but promethazine was associated with greater sedation. [source] | ||||||||||