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  • Original Article
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Methadone versus morphine for treatment of neonatal abstinence syndrome: A prospective randomized clinical trial

Abstract

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 350/7 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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Acknowledgements

We thank the infants and their families who participated in this trial, providers of EMMC NICU Professional Services (Ann Boomer NNP, Janice Gilbert NNP, Dave M. Roberts NNP, Deonne Thibodeau NNP, and Drs Kumar Akilesh, Mary Connolly, Jay Hagerty, and Alison Faulkingham) for their help with enrollment and conducting this trial, the EMMC Nursing Staff of NICU and Pediatrics for caring for these infants and families, and Ms. Sharon LaBrie for assistance with data collection. No external funding was secured for this study.

Author Contributions

Mark S. Brown: Dr Brown conceptualized and designed the study, carried out the initial analysis, drafted the initial manuscript and approved the final manuscript as submitted.

Marie J. Hayes: Dr Hayes’ work in the past has been funded by the NIH. She reviewed the design of the study and the analysis, critically reviewed the manuscript and approved the final manuscript as submitted.

Lynn M. Thornton: Dr Thornton handled the randomization processes, supervised the study assignments and medication preparation, collected data, reviewed and revised the manuscript, and approved the final manuscript as submitted.

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Correspondence to M S Brown.

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The authors declare no conflict of interest.

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Brown, M., Hayes, M. & Thornton, L. Methadone versus morphine for treatment of neonatal abstinence syndrome: A prospective randomized clinical trial. J Perinatol 35, 278–283 (2015). https://doi.org/10.1038/jp.2014.194

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