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

PHASE3CompletedINTERVENTIONAL
Enrollment

304

Participants

Timeline

Start Date

December 3, 2015

Primary Completion Date

November 21, 2018

Study Completion Date

November 21, 2018

Conditions
PainLong-bone Fractures
Interventions
DRUG

Paracetamol

Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g).

DRUG

Ibuprofen

Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).

DRUG

paracetamol + ibuprofen

Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g) Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).

DRUG

Placebo

Placebo will have the closest flavour, smell and aspect to the active substances, respectively paracetamol and ibuprofen. Placebo will be prepared in bottles with a fake label of active substances for a better blinding both for the nurse and the patient. Labels will be hiding by a mask.

Trial Locations (1)

75012

Paediatric emergency Armand Trousseau hospital, Paris

All Listed Sponsors
lead

Assistance Publique - Hôpitaux de Paris

OTHER

NCT02477007 - Analgesic Efficacy of Morphine Alone or Combined With Paracetamol and/or Ibuprofen for Long-bones Fractures in Children | Biotech Hunter | Biotech Hunter