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

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain, Acute
• Intervention / Treatment: Drug: Intranasal fentanyl + Oral Placebo; Drug: Oral Morphine + Intranasal Placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • University Hospital of Montpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the value of the pain feeling	Assessment of the value of the pain feeling measured by visual analogic scale	45 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delay in treatment efficacy	Delay in treatment efficacy measured by a reduction of pain (1 point) assessed by visual analogic scale from the administration of the treatement.	up to 45 minutes

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Gaël GG GUYON, MD, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2017
• Primary Completion (Actual): July 18, 2018
• Study Completion (Actual): March 12, 2019

Study Registration Dates

• First Submitted: January 30, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): December 31, 2020
• Last Update Submitted That Met QC Criteria: December 29, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: children; fentanyl; traumatic pain; intranasal use
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl; Morphine
• Other Study ID Numbers: 9732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No