FINDOL: Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT03063359

Collaborator

(none)

Enrollment

Location

Arms

21.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments.

To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it.

The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute	Drug: Intranasal fentanyl + Oral Placebo Drug: Oral Morphine + Intranasal Placebo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study

Actual Study Start Date :

May 30, 2017

Actual Primary Completion Date :

Jul 18, 2018

Actual Study Completion Date :

Mar 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intranasal fentanyl + Oral placebo Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.	Drug: Intranasal fentanyl + Oral Placebo Administration of intranasal fentanyl (1.5µg/kg) and Oral placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department. Other Names: Intranasal Fentanyl + Oral NaCl
Active Comparator: Oral morphine + Intranasal placebo Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.	Drug: Oral Morphine + Intranasal Placebo Administration of oral morphine (0,4mg/kg) and intranasal placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department. Other Names: Oral Morphine + Intranasal NaCl

Arm

Intervention/Treatment

Experimental: Intranasal fentanyl + Oral placebo

Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.

Drug: Intranasal fentanyl + Oral Placebo

Administration of intranasal fentanyl (1.5µg/kg) and Oral placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.

Other Names:

Intranasal Fentanyl + Oral NaCl

Active Comparator: Oral morphine + Intranasal placebo

Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.

Drug: Oral Morphine + Intranasal Placebo

Administration of oral morphine (0,4mg/kg) and intranasal placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.

Other Names:

Oral Morphine + Intranasal NaCl

Outcome Measures

Primary Outcome Measures

Assessment of the value of the pain feeling [45 minutes]
Assessment of the value of the pain feeling measured by visual analogic scale

Secondary Outcome Measures

Delay in treatment efficacy [up to 45 minutes]
Delay in treatment efficacy measured by a reduction of pain (1 point) assessed by visual analogic scale from the administration of the treatement.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 points)
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