Fractures
Conditions
Keywords
midazolam, sublingual, oral morphine, children, bone fracture, bone fracture with a deformed member
Brief 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.
Interventions
DRUGMidazolam
0.2 mg/kg of sublingual midazolam and 0.5 mg/kg of morphine
DRUGPlacebo
placebo at 0.2 mg/kg and morphine 0.5 mg/kg
Sponsors
URC-CIC Paris Descartes Necker Cochin
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the measurement of pain analogical scale values at 30 minutes between the two groups | after administration until 120 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Pain Analogical scale Values at 15, 30 minutes, 1 hour, 1h30 and 2 hours. | after administration until 120 minutes |
| Respiratory rate, Oxymetry | after administration until 120 minutes |
| Conscience (lethargy or irritability) | after administration until 120 minutes |
| Pain Analogical scale Values after the treatment of the fracture | after administration until 120 minutes |
| skin hyperesthesia, rash | after administration until 120 minutes |
| children cooperation | after surgical procedure |
| nausea, | after administration until 120 minutes |
Countries
France
Outcome results
None listed