Ondansetron to reduce neonatal opioid withdrawal severity a randomized clinical trial.
Journal
Journal of perinatology : official journal of the California Perinatal Association
ISSN: 1476-5543
Titre abrégé: J Perinatol
Pays: United States
ID NLM: 8501884
Informations de publication
Date de publication:
03 2023
03 2023
Historique:
received:
24
05
2022
accepted:
29
07
2022
revised:
26
07
2022
pubmed:
28
8
2022
medline:
10
3
2023
entrez:
27
8
2022
Statut:
ppublish
Résumé
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). 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. 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. Ondansetron treatment reduced the severity of NOWS symptoms; and there was an indication that it could reduce the length of stay. Clinicaltrials.gov NCT01965704.
Identifiants
pubmed: 36030327
doi: 10.1038/s41372-022-01487-2
pii: 10.1038/s41372-022-01487-2
pmc: PMC9968817
mid: NIHMS1833058
doi:
Substances chimiques
Analgesics, Opioid
0
Ondansetron
4AF302ESOS
Morphine
76I7G6D29C
Phenobarbital
YQE403BP4D
Banques de données
ClinicalTrials.gov
['NCT01965704']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
271-276Subventions
Organisme : NICHD NIH HHS
ID : R01 HD070795
Pays : United States
Organisme : NIH HHS
ID : 5RO1HD070795-06A1
Pays : United States
Organisme : NIDA NIH HHS
ID : 5U01DA04439902
Pays : United States
Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Nature America, Inc.
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