Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial.

OBJECTIVE

To determine if treatment with a 5-HT3 antagonist (ondansetron) reduces need for opioid therapy in infants at risk for neonatal opioid withdrawal syndrome (NOWS).

STUDY

DESIGN

A multicenter, randomized, placebo controlled, double blind clinical trial of ninety (90) infants. The intervention arms were intravenous ondansetron or placebo during labor followed by a daily dose of ondansetron or placebo in infants for five days.

RESULTS

Twenty-two (49%) ondansetron-treated and 26 (63%) placebo-treated infants required pharmacologic treatment (p > 0.05). The Finnegan score was lower in the ondansetron-treated group (4.6 vs. 5.6, p = 0.02). A non-significant trend was noted for the duration of hospitalization. There was no difference in need for phenobarbital or clonidine therapy, or total dose of morphine in the first 15 days of NOWS treatment.

CONCLUSIONS

Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay.

CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT01965704.