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

Assistance Publique - Hôpitaux de Paris

Status and phase

Completed

Phase 3

Conditions

Fractures

Treatments

Drug: Placebo

Drug: Midazolam

Study type

Interventional

Funder types

Other

Identifiers

NCT00416039

P051033

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

5 to 16 years old

Volunteers

No Healthy Volunteers

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