B Surran1, P Visintainer, S Chamberlain, K Kopcza, B Shah, R Singh. 1. 1] Division of Newborn Medicine, Baystate Children's Hospital, Springfield, MA, USA [2] Department of Neurology, Boston Medical Center, Boston, MA, USA.
Abstract
OBJECTIVE: To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). STUDY DESIGN: Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. RESULTS: A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. CONCLUSION:Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.
RCT Entities:
OBJECTIVE: To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). STUDY DESIGN: Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatientphenobarbital days, adverse events and treatment failures. RESULTS: A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. CONCLUSION:Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.
Authors: Irma Convertino; Alice Capogrosso Sansone; Alessandra Marino; Maria T Galiulo; Stefania Mantarro; Luca Antonioli; Matteo Fornai; Corrado Blandizzi; Marco Tuccori Journal: Drug Saf Date: 2016-10 Impact factor: 5.606
Authors: Jason R Pryor; Faouzi I Maalouf; Elizabeth E Krans; Robert E Schumacher; William O Cooper; Stephen W Patrick Journal: Arch Dis Child Fetal Neonatal Ed Date: 2017-01-10 Impact factor: 5.747
Authors: Jonathan M Davis; Jeffrey Shenberger; Norma Terrin; Janis L Breeze; Mark Hudak; Elisha M Wachman; Peter Marro; Erica L Oliveira; Karen Harvey-Wilkes; Adam Czynski; Barbara Engelhardt; Karen D'Apolito; Debra Bogen; Barry Lester Journal: JAMA Pediatr Date: 2018-08-01 Impact factor: 16.193