How to Treat Opiate Withdrawal in Neonates

Phase 3 Completed 120 enrolled University of Zurich

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Three different drugs are used in a randomised, double blind, clinical multi-centre trial with three arms. Major objective is to investigate the duration of drug treatment based on the Finnegan score. Secondary objectives are to document weight gain, the need for adding a second drug when the first drug is not effective enough and possible side effects such as convulsions.

Timeline

Start: 2001-06
Primary completion: 2007-12
Completion: 2007-12

Publications

Results Zimmermann U, Rudin C, Duo A, Held L, Bucher HU; Swiss neonatal abstinence syndrome study group. Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial. Eur J Pediatr. 2020 Jan;179(1):141-149. doi: 10.1007/s00431-019-03486-6. Epub 2019 Nov 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Chlorpromazine	Small molecule	0.25 mg/kg	Oral
Comparator	Morphine	Other / unclassified	0.25 mg/kg	Oral
Subject	Phenobarbital	Unknown	0.83 mg/kg	Oral

How to Treat Opiate Withdrawal in Neonates

Summary

Timeline

Publications

Drugs

Indications