Methadone versus morphine for treatment of neonatal abstinence syndrome: a prospective randomized clinical trial.

Document Type


Publication Date



Pediatrics, Pharmacy

Journal Title

Journal of perinatology : official journal of the California Perinatal Association

MeSH Headings

Analgesics, Opioid, Birth Weight, Buprenorphine, Double-Blind Method, Female, Gestational Age, Humans, Infant, Newborn, Length of Stay, Male, Methadone, Morphine, Neonatal Abstinence Syndrome, Prospective Studies, Treatment Outcome


OBJECTIVE: Compare duration of treatment of neonatal abstinence syndrome between methadone and morphine.

STUDY DESIGN: A prospective, double-masked, randomized trial at a single site. Randomization of methadone or morphine was stratified for maternal treatment with methadone or buprenorphine. Inclusion criteria were (i) maternal treatment with prescribed methadone or buprenorphine, (ii) withdrawal treatment criteria, (iii) adjusted gestational age ⩾35(0/7) weeks and (iv) medically stable. Primary outcome was length of opioid treatment.

RESULT: From January 2011 through October 2012, 78 infants were eligible for the study: 41 methadone-exposed and 37 buprenorphine-exposed. Consent was obtained from 31 mothers, 13/41 (32%) methadone-treated and 18/37 (49%) buprenorphine-treated. Length of opioid treatment was significantly shorter for methadone than morphine treatment, median 14 versus 21 days (P=0.008).

CONCLUSION: Methadone had a shorter length of neonatal withdrawal treatment compared with morphine. Owing to the smaller sample size and single site, a larger randomized study is needed.



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