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Prospective Randomized Clinical Trial (prospective + randomized_clinical_trial)
Selected AbstractsIntermittent and Continuous Enteral Nutrition in Critically Ill Dogs: A Prospective Randomized TrialJOURNAL OF VETERINARY INTERNAL MEDICINE, Issue 3 2010M. Holahan Background: Malnutrition is a common problem in critically ill dogs and is associated with increased morbidity and mortality in human medicine. Enteral nutrition (EN) delivery methods have been evaluated in humans to determine which is most effective in achieving caloric goals. Objectives: To compare continuous infusion and intermittent bolus feeding of EN in dogs admitted to a critical care unit. Animals: Fifty-four dogs admitted to the critical care unit and requiring nutritional support with a nasoenteric feeding tube. Methods: Prospective randomized clinical trial. Dogs were randomized to receive either continuous infusion (Group C) or intermittent bolus feeding (Group I) of liquid EN. The percentage of prescribed nutrition delivered (PPND) was calculated every 24 hours. Frequencies of gastrointestinal (GI), mechanical, and technical complications were recorded and gastric residual volumes (GRVs) were measured. Results: PPND was significantly lower in Group C (98.4%) than Group I (100%). There was no significant difference in GI or mechanical complications, although Group C had a significantly higher rate of technical complications. GRVs did not differ significantly between Group C (3.1 mL/kg) and Group I (6.3 mL/kg) and were not correlated with the incidence of vomiting or regurgitation. Conclusions and Clinical Importance: There was a statistically significant difference in the PPND between continuously and intermittently fed dogs, but this difference is unlikely to be clinically relevant. Critically ill dogs can be successfully supported with either continuous infusion or intermittent bolus feeding of EN with few complications. Increased GRVs may not warrant termination of enteral feeding. [source] Effectiveness of two conservative modes of physical therapy in women with urinary stress incontinenceNEUROUROLOGY AND URODYNAMICS, Issue 5 2001Tiina Arvonen Abstract Stress incontinence is the most prevalent form of female urinary incontinence and it affects approximately 5% of younger women to nearly 50% of elderly women. Women have traditionally been treated with pelvic floor muscle exercises alone or with the use of vaginal cones. A new treatment mode, vaginal balls, has been developed. The aim of this study was to compare pelvic floor muscle training with and without vaginal balls and to collect information on women's subjective feelings about the two training modes. The study was carried out as a prospective randomized clinical trial. Thirty-seven women aged 25,65 were assigned either to a pelvic floor muscle training program or to a training program using weighted vaginal balls for 4 months. Treatment outcomes were assessed by a pad-test with a standardized bladder volume, vaginal palpation, and by women's self-reported perceptions. The sense of coherence score was compared with the score for a normal population. Ninety-three percent of the women completed the study. Both training modes were effective in reducing urinary leakage: with vaginal balls (P,<,0.0001) and without (P,<,0.019); and increasing pelvic floor muscle strength: with vaginal balls (P,<,0.0039) and without (P,<,0.0002). However, the reduction of urinary leakage after four months of exercise in the training group with vaginal balls was significantly better (P,<,0.03) than the results in the group training with pelvic floor muscle exercises alone. The study found the weighted vaginal balls to be a good alternative for training pelvic floor muscles in women with stress urinary incontinence. Neurourol. Urodynam. 20:591,599, 2001. © 2001 Wiley-Liss, Inc. [source] Anesthesia for removal of inhaled foreign bodies in childrenPEDIATRIC ANESTHESIA, Issue 11 2004Amit Soodan MD Summary Background:, Foreign body aspiration may be a life-threatening emergency in children requiring immediate bronchoscopy under general anesthesia. Both controlled and spontaneous ventilation techniques have been used during anesthesia for bronchoscopic foreign body removal. There is no prospective study in the literature comparing these two techniques. This prospective randomized clinical trial was undertaken to compare spontaneous and controlled ventilation during anesthesia for removal of inhaled foreign bodies in children. Methods:, Thirty-six children posted for rigid bronchoscopy for removal of airway foreign bodies over a period of 2 years and 2 months in our institution were studied. After induction with sleep dose of thiopentone or halothane, they were randomly allocated to one of the two groups. In group I, 17 children were ventilated after obtaining paralysis with suxamethonium. In group II, 19 children were breathing halothane spontaneously in 100% oxygen. Results:, All the patients in the spontaneous ventilation group had to be converted to assisted ventilation because of either desaturation or inadequate depth of anesthesia. There was a significantly higher incidence of coughing and bucking in the spontaneous ventilation group compared with the controlled ventilation group (P = 0.0012). Conclusion:, Use of controlled ventilation with muscle relaxants and inhalation anesthesia provides an even and adequate depth of anesthesia for rigid bronchoscopy. [source] Oral versus Intravenous Opioid Dosing for the Initial Treatment of Acute Musculoskeletal Pain in the Emergency DepartmentACADEMIC EMERGENCY MEDICINE, Issue 12 2008James R. Miner MD Abstract Objectives:, The objective was to compare the time to medication administration, the side effects, and the analgesic effect at sequential time points after medication administration of an oral treatment strategy using oxycodone solution with an intravenous (IV) treatment strategy using morphine sulfate for the initial treatment of musculoskeletal pain in emergency department (ED) patients. Methods:, This was a prospective randomized clinical trial of patients >6 years old who were going to receive IV morphine sulfate for the treatment of musculoskeletal pain but did not yet have an IV. Consenting patients were randomized to have the treating physician order either 0.1 mg/kg morphine sulfate IV or 0.125 mg/kg oxycodone orally in a 5 mg/5 mL suspension as their initial treatment for pain. The time from the placement of the order to the administration of the medication was recorded. Pain was measured using a 100-mm visual analog scale (VAS) and recorded at 0, 10, 20, 30 and 40 minutes after drug administration. Results:, A total of 405 eligible patients were identified during the study period; 328 (81.0%) patients consented to be in the study. A total of 158 patients were randomized to the IV morphine sulfate treatment group, and 162 were randomized to the oral oxycodone treatment group. Of the patients who were randomized to IV therapy, 34 were withdrawn from the study prior to drug administration; leaving 125 patients in the IV group for analysis. Of the patients who randomized to oral therapy, 22 were withdrawn from the study prior to drug administration, leaving 140 patients for analysis. No serious adverse events were detected. There was a 12-minute difference between the median time of the order and the administration of oral oxycodone (8.5 minutes) and IV morphine (20.5 minutes). The mean percent change in VAS score was larger for patients in the IV therapy group than those in the oral therapy group at 10 and 20 minutes. At 30 and 40 minutes, the authors could no longer detect a difference. The satisfaction scale score was higher after treatment for the morphine group (median = 4; interquartile range [IQR] = 4 to 5) than for the oxycodone group (median = 4; IQR = 2 to 5; p = 0.008). Conclusions:, The oral loading strategy was associated with delayed onset of analgesia and decreased patient satisfaction, but a shorter time to administration. The oral loading strategy using an oxycodone solution provided similar pain relief to the IV strategy using morphine 30 minutes after administration of the drug. Oral 0.125 mg/kg oxycodone represents a feasible alternative to 0.1 mg/kg IV morphine in the treatment of severe acute musculoskeletal pain when difficult or delayed IV placement greater than 30 minutes presents a barrier to treatment. [source] Routine versus Selective Abdominal Computed Tomography Scan in the Evaluation of Right Lower Quadrant Pain: A Randomized Controlled TrialACADEMIC EMERGENCY MEDICINE, Issue 2 2007Christopher C. Lee MD Objectives To determine the role of abdominal computed tomography (CT) imaging in patients with right lower quadrant (RLQ) pain. The authors hypothesized that selective use of abdominal CT would reduce imaging without increasing the rates of negative appendectomy and perforated appendicitis. Methods A prospective randomized clinical trial was conducted in a community teaching emergency department. Adult patients with acute RLQ abdominal pain with suspected acute appendicitis were included. Patients were randomized to mandatory (all patients) or selective (based on clinical evaluation) abdominal CT imaging. The primary outcome was the negative appendectomy rate. Results A total of 152 patients were randomized to selective (n= 80) and mandatory (n= 72) intervention groups. The mean (±SD) age was 34.1 (±3.5) years, and 48% were female. CT imaging was performed in 54 of 80 patients (68%; 95% confidence interval [CI] = 56% to 78%) in the selective group and in 70 of 72 patients (97%; 95% CI = 90% to 100%) in the mandatory group. There was a trend to a decreased rate of negative appendectomy in the mandatory group (1/39 [2.6%]; 95% CI = 0.5% to 13.2%) as compared with the selective group (6/43 [13.9%]; 95% CI = 6.6% to 27.3%), with a difference in prevalence rates of 11.3% (95% CI =,3.5% to 26.3%). There was also a trend to a decreased perforated appendix rate in the mandatory group (4/39 [10.3%]) as compared with the selective group (7/38 [18.4%]), with a difference in prevalence rates of 8.2% (95% CI =,8.0% to 24.4%). Conclusions In this small sample of adult patients with RLQ abdominal pain and suspected acute appendicitis, CT imaging was performed less frequently in the selective group and there was a trend with mandatory CT imaging to reduced rates of negative appendectomy and perforated appendices. [source] Clinical and radiographic characteristics of single-tooth replacements preceded by local ridge augmentation: a prospective randomized clinical trialCLINICAL ORAL IMPLANTS RESEARCH, Issue 12 2008L. Meijndert Abstract Objectives: To assess in a randomized-clinical trial the influence of three augmentation techniques (chinbone with or without a Bio-Gide® membrane and Bio-Oss® with a Bio-Gide® membrane) on the clinical and radiographic characteristics of hard and soft tissues around implants and adjacent teeth in the reconstructed maxillary anterior region, up to 1 year after functional loading. Materials and methods: Ninety-three patients requesting single-tooth replacement and presenting with a horizontal (bucco-palatinal) bone deficiency were included. After augmentation, 93 ITI-EstheticPlus implants were placed. Clinical variables, standardized photographs and radiographs were analysed to assess the impact on the levels of the marginal gingiva (MGL) and marginal bone (MBL) around implants and adjacent teeth, viz at pre-augmentation, pre-implantation (TPI) and 1 (T1) and 12 (T12) months after final crown placement. Results: Implant survival was 97.8%. No significant differences were observed in the treatment outcomes of the three augmentation modalities. Combining the three modalities, a slight but significant increase in the implants approximal pocket depth was found between T1 and T12. Approximal bone loss at the implant between T1 and T12 was 0.14 ± 0.76 mm (mesial) and 0.14 ± 0.47 mm (distal); the approximal MGL slightly increased (mesial: 0.24 ± 0.46 mm, distal: 0.25 ± 0.66 mm), and the buccal MGL decreased (0.11 ± 0.61 mm). Bone loss at the adjacent teeth, although minor, was significant between TPI and T1. No correlations were observed in changes of MBL and MGL. Conclusions: None of the three applied augmentation technique procedures influenced the characteristics of the MGL and MBL or the implant survival of single-tooth replacements. Peri-implant hard and soft tissues were very stable in the first year after loading. [source] | ||||||||||