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

Study Overview
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Brief Summary
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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.

Official Title
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Non-inferiority of Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma : a Controled Randomized , Single Blind Study

Conditions
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Pain, Acute

Intervention / Treatment
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* Drug: Intranasal fentanyl + Oral Placebo
* Drug: Oral Morphine + Intranasal Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal fentanyl + Oral placebo<br>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<br>* 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.<br>* Other names: Intranasal Fentanyl + Oral NaCl;|
| Active Comparator: Oral morphine + Intranasal placebo<br>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<br>* 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.<br>* Other names: Oral Morphine + Intranasal NaCl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the value of the pain feeling | Assessment of the value of the pain feeling measured by visual analogic scale | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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traumatic pain, children, fentanyl, intranasal use