Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children

• Status: Completed
• Trial end date: 2018-11-21
• Target enrollment: 0
• Participant gender: All

Summary

The main objective of this study is 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 and also to study the potential synergic effect of the association paracetamol and ibuprofen.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Acetaminophen; Analgesics; Ibuprofen; Morphine

Criteria

Inclusion Criteria:

• children aged 2 through 17 years (17 years included)

• suspected fracture of a long bone requiring morphine analgesia (VAS ≥ 60/100 or Evendol ≥ 7/15 at the arrival at emergency department)

• within the first 12 hours after the injury

• at least one signed parental informed consent

• affiliated to health insurance

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

• resuscitation manœuvres

• suspected femur fracture

• open fracture

• pregnant women in the third trimester