Non-inferiority of intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma : a controled randomized , single blind study

INTERVENTION: Trade Name: Oramorph Product Name: sulfate de morphine Pharmaceutical Form: Oral solution Other descriptive name: MORPHINE SULFATE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 30/5‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Oral use Trade Name: Fentanyl Product Name: Fentanyl Pharmaceutical Form: Solution for injection Other descriptive name: FENTANYL Concentration unit: µg/ml microgram(s)/millilitre Concentration type: equal Concentration number: 500/10‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Oral use CONDITION: Therapeutic area: Diseases [C] ‐ Symptoms and general pathology [C23] traumatic pain PRIMARY OUTCOME: Main Objective: To assess the non inferiority of a treatment by Fentanyl intranasal vs morphin sulfate (oral use) in children suffering from traumatic pain Primary end point(s): Passessment of the pain feeling defined by Visual analogic scale (face scale and analogic scale) Secondary Objective: to assess : ; Tolerability; Feasability of the administation of the treatment; onset of treatments efficacity; Timepoint(s) of evaluation of this end point: 45 minutes SECONDARY OUTCOME: Secondary end point(s): 1.Onset of treatment efficacity ; 2.treatment failure ; 3.Adverse events ; Timepoint(s) of evaluation of this end point: 1. up to 45 minutes ; 2. Up to 1 hour ; 3. up to 48 hours INCLUSION CRITERIA: ‐Patient aged between 4 years old and 15,3 years old ‐Acute pain in traumatic context with a suspicion of fracture for patient <7years old : feeling Pain>6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not <10 oints) ‐ For patients >7 years old : feeling pain >6 points and defined thanks to a visual analogic scale ‐Informed consent form signed by parents ‐ Beneficiary of an european health protection Are the trial subjects under 18? yes Number of subjects for this age range: 82 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