EUCTR2016-003658-34-FR
Active, not recruiting
Phase 1
on-inferiority of intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma : a controled randomized , single blind study - FINDO
niversity Hospital of Montpellier0 sitesJanuary 10, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- traumatic pain
- Sponsor
- niversity Hospital of Montpellier
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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 \<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
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
Outcomes
Primary Outcomes
Not specified
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