traumatic pain
Conditions
Interventions
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:
Sponsors
University Hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
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 6/10 defined with a face analogue scale and a visual analogic scale (the difference between the scales is not 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
Exclusion criteria
Exclusion criteria: Antalgic ( II or III) within 4 hours before the inclusion Allergic or non-indication of fentanyl Allergic or contraindication of morphine sulfate pre Existing peripheral intravenous catheter Traumatic brain injury nasal traumatic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the non inferiority of a treatment by Fentanyl intranasal vs morphin sulfate (oral use) in children suffering from traumatic pain ;Secondary Objective: to assess : Tolerability Feasability of the administation of the treatment onset of treatments efficacity ;Primary end point(s): Passessment of the pain feeling defined by Visual analogic scale (face scale and analogic scale);Timepoint(s) of evaluation of this end point: 45 minutes | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
France
Contacts
Public ContactResearch Department _ sponsor Unit
Research Department of Montpellier Hospital
Outcome results
None listed