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Adjunctive therapy for neonatal opioid dependence: Do we really know what’s best?

Journal of Perinatology volume 34, page 574 (2014)Cite this article

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I applaud Surran et al.1 in their effort to better understand optimal treatment strategies for neonatal opioid dependence. I am however surprised by their conclusions, based on their submitted data. An interim analysis of their data supported early termination because clinical significance was reached demonstrating a reduction in morphine treatment time for the phenobarbital-treated group, a finding opposite to their hypothesis. Given the low conditional power of their hypothesis, there was no justification to continue enrollment. Despite these findings, the authors argued that clonidine was superior to phenobarbital as an adjunctive therapy in this population, since the reduction in inpatient days was not felt to be clinically significant (4.6 days). However, when calculating sample size, the authors noted that a 5-day difference in morphine duration was ‘considered clinically meaningful.’

The justification provided by Surran et al. for claiming the superiority of clonidine was the ‘robust emerging evidence establishing the negative consequences of medications as phenobarbital on developing brain growth.’ The authors do not provide any relevant data in their study, nor is there any robust follow-up data in the literature addressing the specific population of opiate-exposed newborns treated with phenobarbital.

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References

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Authors and Affiliations

  1. Department of Pediatrics, The Warren Alpert Medical School of Brown University, Providence, RI, USA

    M G Coyle

  2. Department of Neonatology, Women & Infants Hospital, Providence, RI, USA,

    M G Coyle

  3. Department of Pediatrics, St Luke’s Hospital, New Bedford, MA, USA,

    M G Coyle

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  1. M G Coyle
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Correspondence to M G Coyle.

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Coyle, M. Adjunctive therapy for neonatal opioid dependence: Do we really know what’s best?. J Perinatol 34, 574 (2014). https://doi.org/10.1038/jp.2014.95

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