intranasal fentanyl versus oral morphine sulfate in the treatment of pain in pediatric trauma

Phase 1

• Conditions: traumatic pain; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2016-003658-34-FR
• Lead Sponsor: niversity Hospital of Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-10
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 : <br>Tolerability<br>Feasability of the administation of the treatment<br>onset of treatments efficacity<br> ;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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1.Onset of treatment efficacity<br>2.treatment failure<br>3.Adverse events<br>;Timepoint(s) of evaluation of this end point: 1. up to 45 minutes<br>2. Up to 1 hour<br>3. up to 48 hours