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Clinical Trials/EUCTR2016-003658-34-FR
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.

Registry
who.int
Start Date
January 10, 2017
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospital of Montpellier

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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