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

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Midazolam; Morphine

Criteria

Inclusion Criteria:

• children between 5 and 16 years old

• children with a disjoined bone fracture

• children needed oral morphine analgesia

• written informed consent from one or the two parents or legal pad

Exclusion Criteria:

• ASA score > 2

• concomitant administration of oral analgesia (level II WHO classification) less than 6 hours

• concomitant administration of benzodiazepine less than 24 hours