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 : Recruiting
First Posted : February 24, 2017
Last Update Posted : January 7, 2019
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||May 2021|
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
- 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
- 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.
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
|Contact: Gael GG GUYON, MD||+334 67 33 22 email@example.com|
|Contact: Maelis RAITIERE, Intern||+334 67 33 22 firstname.lastname@example.org|
|University hospital of Montpellier||Recruiting|
|Montpellier, France, 34295|
|Contact: Gaël GG GUYON, MD email@example.com|
|Principal Investigator:||Gaël GG GUYON, MD||Montpellier University Hospital|