TY - JOUR
T1 - Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial
AU - Peltz, Gary
AU - Jansson, Lauren M.
AU - Adeniyi-Jones, Susan
AU - Cohane, Carol
AU - Drover, David
AU - Shafer, Steven
AU - Wang, Meiyue
AU - Wu, Manhong
AU - Govindaswami, Balaji
AU - Jegatheesan, Priya
AU - Argani, Cynthia
AU - Khan, Salwa
AU - Kraft, Walter K.
N1 - Publisher Copyright:
© 2022, The Author(s), under exclusive licence to Springer Nature America, Inc.
PY - 2023/3
Y1 - 2023/3
N2 - 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
AB - 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
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U2 - 10.1038/s41372-022-01487-2
DO - 10.1038/s41372-022-01487-2
M3 - Article
C2 - 36030327
AN - SCOPUS:85137062042
SN - 0743-8346
VL - 43
SP - 271
EP - 276
JO - Journal of Perinatology
JF - Journal of Perinatology
IS - 3
ER -