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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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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

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Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Midazolam and morphine

Group Type EXPERIMENTAL

Midazolam

Intervention Type DRUG

0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine

2

placebo, Nacl 0.9 %, morphine 0.5 mg/kg

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo at 0.2 mg/kg and morphine 0.5 mg/kg

Interventions

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Midazolam

0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine

Intervention Type DRUG

Placebo

placebo at 0.2 mg/kg and morphine 0.5 mg/kg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No