NCT00416039

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

Clinical Randomized Study of Sublingual Midazolam in Association With Morphine by Oral Route in Arm Fracture in Children at the Emergency Children Care

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 5 Years – 16 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Fracture is often responsible of pain in the paediatric emergency department (ED). This pain is very severe and needs effective drugs. During a study made at the ED of Necker Enfants Malades Hospital, it has been shown that the oral morphine had a limited action on this kind of pain. Therefore it is interesting to increase the analgesia by making a drug association, for example with the midazolam witch is a benzodiazepine with a sedative and anxiolytic action, and which has got the MMA for the intravenous and the intra rectal forms for children older than 6 months. The intravenous form has some disadvantages like an extra work and an increase of risk of side effects. That is why the sublingual form seems to be interesting in this context. Even if some studies have shown the benefit of midazolam as a preanesthetic medication given to children scheduled for a surgical procedure, none has shown the interest of sublingual midazolam associated with oral morphine to relieve the pain due to a displaced fracture. The aim of this study is to show a more important pain decrease in the group taking midazolam versus placebo. 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 pain will be quantified thanks to the visual analogical scale (VAS)before and 30 minutes after the drugs administration, and we will try to show a difference of 15 points(on 100) of the VAS at 30 minutes between the two groups. 60 patients aged from 5 to 16 years old and having a displaced fracture will be enrolled in this study which will last 1 year. Patients having a contra-indication for morphine and midazolam won't be enrolled as patients with femoral fracture which needs a local anaesthesia.

Conditions

• Fractures

Interventions

Type	Name	Description
DRUG	Midazolam	0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
DRUG	Placebo	placebo at 0.2 mg/kg and morphine 0.5 mg/kg

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-11-01
• Completion: 2009-02-01
• First posted: 2006-12-27
• Last updated: 2025-11-20

Locations

1 site across 1 country: France