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Blind Design (blind + design)
Selected AbstractsDouble-Blind, Randomized, Placebo-Controlled, Dose-Response Study of the Safety and Efficacy of Botulinum Toxin Type A in Subjects with Crow's FeetDERMATOLOGIC SURGERY, Issue 3 2005Nicholas J. Lowe MD Background Published evidence suggests that botulinum toxin type A (BTX-A) is an effective treatment for crow's feet. However, few dose-ranging studies have been performed. Objectives To assess the safety and efficacy of a single treatment with one of four doses of BTX-A (Botox/Vistabel, Allergan Inc) compared with placebo for the improvement of crow's feet. Methods Subjects received a single bilateral treatment of 18, 12, 6, or 3 U of BTX-A or placebo injected into the lateral aspect of the orbicularis oculi muscle (parallel-group, double,blind design). Investigators and subjects rated crow's feet severity at maximum smile on day 7 and at 30-day intervals from days 30 to 180. Results As observed by both investigators and subjects, all doses of BTX-A resulted in improvements in crow's feet severity when compared with placebo. A dose-dependent treatment effect for efficacy was observed, with higher doses having an increased magnitude and duration of effect. However, a clear differentiation between the 18 U and 12 U doses was not apparent. Few adverse events were reported, with no statistically significant differences between BTX-A and placebo in the incidence of subjects experiencing adverse events. Conclusion BTX-A is safe and effective in decreasing the severity of crow's feet, with 12 U per side suggested as the most appropriate dose. THIS STUDY WAS FUNDED BY ALLERGAN, WHICH WAS ALSO INVOLVED IN THE DESIGN AND CONDUCT OF THE STUDY; COLLECTION, MANAGEMENT, ANALYSIS, AND INTERPRETATION OF THE DATA; AND PREPARATION, REVIEW, AND APPROVAL OF THE MANUSCRIPT. DRS. LOWE AND FRACZEK ARE PAID CONSULTANTS FOR ALLERGAN, DRS. KUMAR AND EADIE ARE EMPLOYEES OF ALLERGAN, AND DRS. LOWE AND KUMAR HOLD STOCK OPTIONS. [source] Prevalence of cervical spinal pain in craniomandibular pain patientsEUROPEAN JOURNAL OF ORAL SCIENCES, Issue 2 2001Corine M. Visscher It has often been suggested that patients with a craniomandibular disorder (CMD) more often suffer from a cervical spine disorder (CSD) than persons without a CMD. However, in most studies no controlled, blind design was used, and conclusions were based on differing signs and symptoms. In this study, the recognition of CMD and CSD was based upon the presence of pain. The aim of this study was to determine the prevalence of cervical spinal pain in persons with or without craniomandibular pain, using a controlled, single-blind design. From 250 persons, a standardised oral history was taken, and a physical examination of the masticatory system and the neck was performed. Three classification models were used: one based on symptoms only; a second on signs only; and a third one based on a combination of symptoms and signs. The CMD patients were also subdivided in three subgroups: patients with mainly myogenous pain; mainly arthrogenous pain; and both myogenous and arthrogenous pain. Craniomandibular pain patients more often showed cervical spinal pain than persons without craniomandibular pain, independent of the classification model used. No difference in the prevalence of cervical spinal pain was found between the three subgroups of craniomandibular pain patients. [source] Clinical tests in distinguishing between persons with or without craniomandibular or cervical spinal pain complaintsEUROPEAN JOURNAL OF ORAL SCIENCES, Issue 6 2000Corine M. Visscher The recognition of a craniomandibular or cervical spinal pain is usually based upon the pain complaint of the patient, reported during an oral history, and the pain responses provoked in a clinical examination. Often used clinical tests are palpation, and function tests like dynamic/static tests or active movements. The relative importance of these tests for the recognition of the musculoskeletal pain is important. Therefore, it was the aim of the present study to determine which test, or combination of tests, best discriminates between persons with or without craniomandibular and/or cervical spinal pain complaints. Two hundred and fifty persons participated. From each person, a standardized oral history was taken. Then, in a randomized order and using a blind design, physical examinations of the craniomandibular system and of the neck were performed. Forward stepwise logistic regression analyses showed that the dynamic/static tests discriminated better between persons with and without pain complaints than the other tests did. In conclusion, in studies to the coexistence of craniomandibular and cervical spinal pain, it may be a good choice to base the recognition of these disorders on the pain complaints reported in the oral history which are verified by the pain response of the dynamic/static tests. [source] Continuous incisional infusion of local anesthetic in pediatric patients following open heart surgeryPEDIATRIC ANESTHESIA, Issue 6 2009CHRISTOPHER F. TIROTTA MD MBA Summary Aim:, To determine the efficacy and safety of a continuous subcutaneous local anesthetic (LA) infusion in pediatric patients following open heart surgery. Background:, The use of a continuous LA infusion has been shown to be beneficial following adult cardiac surgery. To date there are no studies in the pediatric population. Methods/Materials:, Using a prospective, randomized, and double blind design, we compared LA, either 0.25% levobupivacaine or bupivacaine (Treatment Group) to saline (Placebo Group) delivered subcutaneously via a continuous infusion for 72 h after open heart surgery in 72 patients. Requirements for postoperative analgesics and pain scores were recorded for 72 h and plasma levels of local anesthetic were measured. Secondary outcomes measures included time to first oral intake, time to first bowel movement, time to urinary catheter removal, length of stay, requirements for antiemetics and additional sedation. Results:, Total morphine requirements over the first 24 h were less in the Treatment Group than the Placebo Group (0.05 mg·kg,1 vs 0.2 mg·kg,1, P = 0.007); this was true for all patient groups except those patients weighing less than 6.3 kg. The number of patients requiring no morphine was greater in the Treatment Group (7/35 vs 1/37, P = 0.02). The Treatment Group also received less midazolam, lorazepam, and ketorolac than the Placebo Group over 72 h due to the reduced clinical need for these agents in patients weighing less than 31 kg. There were no differences in secondary outcomes. Conclusions:, A continuous incisional infusion of LA reduced postoperative analgesic requirement and sedative use in pediatric patients undergoing a median sternotomy incision. Dosed at a maximum rate of 0.4 mg·kg,1·h,1, a continuous incisional infusion of LA is effective and safe for up to 72 h, with plasma levels of local anesthetic well below the toxic threshold. [source] Time dependent pharmacokinetics of albendazole in humanBIOPHARMACEUTICS AND DRUG DISPOSITION, Issue 5 2003A. Mirfazaelian Abstract The pharmacokinetics of the main metabolites of albendazole (albendazole sulphoxide (ABZ-SO) and albendazole sulphone (ABZ-SO2)) were studied in 12 healthy human volunteers in a double blind design on the first and last days of oral administration of 800 mg albendazole daily for 15 days. No significant differences were observed in Cmax, Tmax and Vd/F of ABZ-SO, whereas the AUC, AUMC and T1/2 of this metabolite were significantly reduced and Cl/F was significantly increased in multiple dosing. There were also no significant differences in the Cmax, Tmax, Vd/F and T1/2 of ABZ-SO2, whereas the AUC and AUMC of this metabolite were significantly reduced and Cl/F was significantly increased in multiple dosing. These observations suggest time dependent pharmacokinetics of albendazole (observed for ABZ-SO and ABZ-SO2), which was explained on the basis of the induction of enzymes involved in the metabolism of ABZ-SO (albendazole sulphoxide) to metabolites other than albendazole sulphone in multiple dosing. Copyright © 2003 John Wiley & Sons, Ltd. [source] | ||||||||||