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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

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring traumatic pain, children, fentanyl, intranasal use

Eligibility Criteria

4 Years - 15 Years (Child)All SexesDoes not accept 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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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