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

Study Overview
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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.

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.

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

Conditions
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Fractures

Intervention / Treatment
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* Drug: Midazolam
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Midazolam and morphine | Drug: Midazolam<br>* 0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine<br>|
| Placebo Comparator: 2<br>placebo, Nacl 0.9 %, morphine 0.5 mg/kg | Drug: Placebo<br>* placebo at 0.2 mg/kg and morphine 0.5 mg/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the measurement of pain analogical scale values at 30 minutes between the two groups |  | after administration until 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours. |  | after administration until 120 minutes | 
| Pain Analogical scale Values after the treatment of the fracture |  | after administration until 120 minutes | 
| Respiratory rate, Oxymetry |  | after administration until 120 minutes | 
| Conscience (lethargy or irritability) |  | after administration until 120 minutes | 
| nausea, |  | after administration until 120 minutes | 
| skin hyperesthesia, rash |  | after administration until 120 minutes | 
| children cooperation |  | after surgical procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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midazolam, sublingual, oral morphine, children, bone fracture, bone fracture with a deformed member