Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma (FINDOL)
Primary Purpose
Pain, Acute
Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Intranasal fentanyl + Oral Placebo
Oral Morphine + Intranasal Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Acute focused on measuring traumatic pain, children, fentanyl, intranasal use
Eligibility 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
Sites / Locations
- University hospital of Montpellier
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intranasal fentanyl + Oral placebo
Oral morphine + Intranasal placebo
Arm Description
Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.
Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.
Outcomes
Primary Outcome Measures
Assessment of the value of the pain feeling
Assessment of the value of the pain feeling measured by visual analogic scale
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03063359
First Posted
January 30, 2017
Last Updated
December 29, 2020
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03063359
Brief Title
Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma
Acronym
FINDOL
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
The new pain protocols imposed by the HAS make it difficult to include new patients in the study
Study Start Date
May 30, 2017 (Actual)
Primary Completion Date
July 18, 2018 (Actual)
Study Completion Date
March 12, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
traumatic pain, children, fentanyl, intranasal use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intranasal fentanyl + Oral placebo
Arm Type
Experimental
Arm Description
Administration of intranasal fentanyl (1.5µg/kg) and oral placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.
Arm Title
Oral morphine + Intranasal placebo
Arm Type
Active Comparator
Arm Description
Administration of oral morphine (0.4mg/kg) and intranasal placebo in children with acute pain in traumatic context on arrival in emergency pediatric department.
Intervention Type
Drug
Intervention Name(s)
Intranasal fentanyl + Oral Placebo
Other Intervention Name(s)
Intranasal Fentanyl + Oral NaCl
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oral Morphine + Intranasal Placebo
Other Intervention Name(s)
Oral Morphine + Intranasal NaCl
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of the value of the pain feeling
Description
Assessment of the value of the pain feeling measured by visual analogic scale
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Delay in treatment efficacy
Description
Delay in treatment efficacy measured by a reduction of pain (1 point) assessed by visual analogic scale from the administration of the treatement.
Time Frame
up to 45 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaël GG GUYON, MD
Organizational Affiliation
Montpellier University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma
We'll reach out to this number within 24 hrs