D Shende1, N Bharti, S Kathirvel, R Madan. 1. Department of Anaesthesia, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, A.I.I.M.S., Ansari Nagar, New Delhi, India.
Abstract
BACKGROUND:Pediatric strabismus surgery is associated with a very high incidence of postoperative nausea and vomiting [(PONV) 44-88%]. Droperidol (10-75 microg kg(-1)) and ondansetron (50-150 microg kg(-1)) have shown variable success in reducing the incidence and severity of PONV. Combination of these two drugs has shown promising results. This randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of the combination of these two drugs in reducing the incidence and severity of PONV in pediatric strabismus surgery. METHODS: After institutional approval and parental informed consent, 240 children of ASA physical status I and II of either sex, aged 1-15 years were included in this study. None of the children received any premedication and a standardized anesthesia technique was used for all the children. They were prospectively randomized to one of the four treatment groups. Group PP received normal saline placebo intravenously after induction and at the end of the procedure. Group DP received droperidol 25 microg kg(-1) after induction and normal saline at the end. Group OP received ondansetron 150 microg kg(-1) after induction and saline at the end. Group DO received droperidol 15 microg kg(-1) after induction and ondansetron 100 microg kg(-1) at the end. RESULTS: Combination prophylaxis resulted in a lower incidence of PONV (13%) as compared to placebo (62.5%, P<0.001), ondansetron (37%, P<0.001), or droperidol (32%, P<0.01). CONCLUSION:Droperidol 15 microg kg(-1) in combination with ondansetron 100 microg kg(-1), administered at the induction and end of the operative procedure respectively, is more effective than either drug given individually in reducing the incidence of PONV after strabismus surgery.
RCT Entities:
BACKGROUND: Pediatric strabismus surgery is associated with a very high incidence of postoperative nausea and vomiting [(PONV) 44-88%]. Droperidol (10-75 microg kg(-1)) and ondansetron (50-150 microg kg(-1)) have shown variable success in reducing the incidence and severity of PONV. Combination of these two drugs has shown promising results. This randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy and safety of the combination of these two drugs in reducing the incidence and severity of PONV in pediatric strabismus surgery. METHODS: After institutional approval and parental informed consent, 240 children of ASA physical status I and II of either sex, aged 1-15 years were included in this study. None of the children received any premedication and a standardized anesthesia technique was used for all the children. They were prospectively randomized to one of the four treatment groups. Group PP received normal saline placebo intravenously after induction and at the end of the procedure. Group DP received droperidol 25 microg kg(-1) after induction and normal saline at the end. Group OP received ondansetron 150 microg kg(-1) after induction and saline at the end. Group DO received droperidol 15 microg kg(-1) after induction and ondansetron 100 microg kg(-1) at the end. RESULTS: Combination prophylaxis resulted in a lower incidence of PONV (13%) as compared to placebo (62.5%, P<0.001), ondansetron (37%, P<0.001), or droperidol (32%, P<0.01). CONCLUSION:Droperidol 15 microg kg(-1) in combination with ondansetron 100 microg kg(-1), administered at the induction and end of the operative procedure respectively, is more effective than either drug given individually in reducing the incidence of PONV after strabismus surgery.
Authors: Fabian Heuser; Christian M Schulz; Alexander Hapfelmeier; Nadine Lehnen; Eberhard F Kochs; Klaus J Wagner Journal: BMC Anesthesiol Date: 2016-10-10 Impact factor: 2.217