/A

Conditions: MedDRA version: 18.0Level: LLTClassification code 10017077Term: Fracture boneSystem Organ Class: 100000004863

Registration Number: EUCTR2015-001458-14-FR

Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Children aged 2 through 17 years (17 years included) accompanied by at least one of their parents in the emergency department

- Suspected fracture of a long bone requiring morphine analgesia (VAS >= 60/100 or Evendol >= 7/15 at the arrival at emergency departement)

- Within the first 12 hours after the injury

- At least on signed parental informed consent
- Affiliated to health insurance
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Analgesic treatment within the 6 hours before inclusion
- Contraindication to one of the experimental drug :Paracetamol or Ibuprofen
- Contraindication to Morphine
- Cognitive impairment
- Multiple injuries
- Ressuscitation manoeuvres
- Suspected femur fracture
- Open fracture
- Pregnant women in the thrird trimester

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objective:<br><br>To evaluate the efficacy of two drugs: paracetamol and ibuprofen in association with morphine, compared with morphine alone on analgesia in children seen in the emergency department for a long-bone fracture. To study the potential synergic effect of the association paracetamol and ibuprofen.;Secondary Objective: Secondary objectives:<br><br>- To compare the long term analgesic efficacy of 4 analgesic regimens a) ibuprophene/morphine,<br> b) paracetamol/morphine, c) ibuprofen/paracetamol/morphine and d) morphine for long bone fracture managment in the pediatric emergency department.<br>To assess the tolerance of these 4 regimens.<br><br>;Primary end point(s):

Secondary Outcome Measures