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

NCT03063359 | Terminated Phase 3 DMC

• 1 other identifier: 9732
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

traumatic pain; children; fentanyl; intranasal use

Outcome Measures

Primary Outcomes (1)

• Assessment of the value of the pain feeling

  Assessment of the value of the pain feeling measured by visual analogic scale

  45 minutes

Secondary Outcomes (1)

• Delay in treatment efficacy

  up to 45 minutes

Study Arms (2)

Intranasal fentanyl + Oral placebo

EXPERIMENTAL

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

Oral morphine + Intranasal placebo

ACTIVE COMPARATOR

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

Interventions

Intranasal fentanyl + Oral Placebo DRUG

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.

Also known as: Intranasal Fentanyl + Oral NaCl

Intranasal fentanyl + Oral placebo

Oral Morphine + Intranasal Placebo DRUG

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.

Also known as: Oral Morphine + Intranasal NaCl

Oral morphine + Intranasal placebo

Eligibility Criteria

• Age: 4 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Allergic or non-indication of fentanyl
• Allergic or contraindication of morphine sulfate
• Pre existing peripheral intravenous catheter
• Traumatic brain injury
• Nasal traumatic

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Morphine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Gaël GG GUYON, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 24, 2017
• Study Start: May 30, 2017
• Primary Completion: July 18, 2018
• Study Completion: March 12, 2019
• Last Updated: December 31, 2020

Record last verified: 2020-12

Locations

FR (1)