Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture

Phase 3 Completed 60 enrolled Assistance Publique - Hôpitaux de Paris URC-CIC Paris Descartes Necker Cochin · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

It is a randomized simple-blind monocentric study; the group A will receive oral morphine with placebo and the group B will receive oral morphine with sublingual midazolam. The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo.

Timeline

Start: 2007-01
Primary completion: 2008-11
Completion: 2009-02

Publications

Background 21480984
Results Wille-Ledon C, Chappuy H, Giraud C, Treluyer JM, Cheron G. Comparison of a morphine and midazolam combination with morphine alone for paediatric displaced fractures: a randomized study. Acta Paediatr. 2011 Nov;100(11):e203-7. doi: 10.1111/j.1651-2227.2011.02311.x. Epub 2011 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	0.2 mg/kg	Other
Background	Morphine	Other / unclassified	0.5 mg/kg	Oral

Indications

No indication recorded.