Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial

Abstract

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.

Figure 1.

Study design

Figure 2.

Patient flow CONSORT diagram

Figure 3.

These graphs compare the secondary outcomes of total dose of morphine administered and the average modified Finnegan score in the placebo and ondansetron-treated groups.

Figure 4.

This bar graph shows the number subjects in the placebo and ondansetron-treated groups with a duration of hospitalization for each indicated time. It is noteworthy that the number of ondansetron-treated subjects with a duration of hospitalization that was less than ≤5 days or 6-10 days was increased but was decreased among those whose hospital stays was ≥16 days (vs. placebo).