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

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ClinicalTrials.gov Identifier: NCT03063359
Recruitment Status : Terminated (The new pain protocols imposed by the HAS make it difficult to include new patients in the study)
First Posted : February 24, 2017
Last Update Posted : December 31, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : July 18, 2018
Actual Study Completion Date : March 12, 2019

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Arms and Interventions
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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 Name: 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 Name: Oral Morphine + Intranasal NaCl


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of the value of the pain feeling [ Time Frame: 45 minutes ]
    Assessment of the value of the pain feeling measured by visual analogic scale


Secondary Outcome Measures :
  1. Delay in treatment efficacy [ Time Frame: 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
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Ages Eligible for Study:   4 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063359


Locations
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France
University hospital of Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Gaël GG GUYON, MD Montpellier University Hospital
More Information
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03063359    
Other Study ID Numbers: 9732
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: December 31, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
traumatic pain
children
fentanyl
intranasal use
Additional relevant MeSH terms:
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Acute Pain
Pain
Neurologic Manifestations
Fentanyl
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics