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Safety and Efficacy of Flumazenil in Reversing Conscious Sedation in the Emergency Department
Author(s) -
Chudnofsky Carl R.
Publication year - 1997
Publication title -
academic emergency medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.221
H-Index - 124
eISSN - 1553-2712
pISSN - 1069-6563
DOI - 10.1111/j.1553-2712.1997.tb03657.x
Subject(s) - medicine , flumazenil , sedation , midazolam , anesthesia , placebo , fentanyl , regimen , randomized controlled trial , alertness , emergency department , surgery , benzodiazepine , receptor , alternative medicine , pathology , psychiatry , pharmacology
Objectives : To evaluate the safety and efficacy of flumazenil vs placebo in reversing fentanyl and midazolam‐induced conscious sedation in ED patients undergoing a short, painful procedure. Methods : This was a multicenter, randomized, parallel, double‐blind, placebo‐controlled study conducted at 9 university‐affiliated teaching hospitals. Patients >18 years of age requiring conscious sedation for a painful procedure expected to last <20 minutes were eligible for inclusion in the study. Patients received 2 μg/kg of fentanyl, followed by midazolam titrated to the desired level of sedation. Patients were then randomized to receive either flumazenil or placebo in a 3:1 ratio (flumazenihplacebo). Vital signs, O 2 saturation, and alertness were recorded at regular intervals. Prior to ED release, patients were asked to rate the amount of discomfort they experienced and the level of relaxation achieved on a 10‐cm visual analog scale (VAS). They also were questioned about their recall for the procedure and satisfaction with the drug regimen. Physicians also rated their satisfaction with the drug regimen on a 10‐cm VAS. Results : Overall, 133 patients received flumazenil and 46 patients received placebo. Patients in the 2 groups received similar doses of midazolam. The patients who received flumazenil returned to baseline alertness earlier (11.1 min vs 24.8 min, p < 0.001) and at a faster rate than did the patients given placebo. Actual intervals from procedure completion until release from the ED did not differ between the 2 groups (98.2 ± 3.6 min flumazenil vs 96.9 ± 5.8 min placebo; p = 0.89). The amounts of discomfort experienced, levels of relaxation achieved, recalls for the procedure, and both patient and physician satisfactions were also similar for the 2 groups. There were no serious adverse effects related to the study drug, and minor adverse effects were similar for the 2 groups. Conclusion : Flumazenil is safe and efficacious in reversing midazolam‐induced sedation in ED patients given a combination of fentanyl and midazolam to facilitate the performance of a short, painful procedure. The patients given flumazenil returned to baseline alertness earlier and at a faster rate than did the patients given placebo. However, flumazenil did not alter the actual interval from procedure completion until ED release.