Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture (MIDAZODOL)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Clinical Randomized Study of Sublingual Midazolam in Association With Morphine by Oral Route in Arm Fracture in Children at the Emergency Children Care|
- Difference in the measurement of pain analogical scale values at 30 minutes between the two groups [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
- Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours. [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
- Pain Analogical scale Values after the treatment of the fracture [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
- Respiratory rate, Oxymetry [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
- Conscience (lethargy or irritability) [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
- nausea, [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
- skin hyperesthesia, rash [ Time Frame: after administration until 120 minutes ] [ Designated as safety issue: Yes ]
- children cooperation [ Time Frame: after surgical procedure ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Study Completion Date:||February 2009|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
Midazolam and morphine
0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
Placebo Comparator: 2
placebo, Nacl 0.9 %, morphine 0.5 mg/kg
placebo at 0.2 mg/kg and morphine 0.5 mg/kg
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416039
|Hopital Necker enfants Malade - Department of Pediatric Emergency|
|Paris, France, 75015|
|Principal Investigator:||Gérard CHERON, MD, PhD||Assistance Publique - Hôpitaux de Paris|