Status:
COMPLETED
Efficacy of Sublingual Midazolam in Association With Oral Morphine in Children Analgesia After Bone Fracture
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Fractures
Eligibility:
All Genders
5-16 years
Phase:
PHASE3
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...
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...
Eligibility Criteria
Inclusion
- 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
- ASA score \> 2
- concomitant administration of oral analgesia (level II WHO classification) less than 6 hours
- concomitant administration of benzodiazepine less than 24 hours
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00416039
Start Date
January 1 2007
End Date
February 1 2009
Last Update
November 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hopital Necker enfants Malade - Department of Pediatric Emergency
Paris, France, 75015