304
Participants
Start Date
December 3, 2015
Primary Completion Date
November 21, 2018
Study Completion Date
November 21, 2018
Paracetamol
Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g).
Ibuprofen
Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).
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).
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.
Paediatric emergency Armand Trousseau hospital, Paris
Assistance Publique - Hôpitaux de Paris
OTHER