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

Phase 3

Terminated

• Conditions: Pain, Acute
• Interventions: Drug: Intranasal fentanyl + Oral Placebo; Drug: Oral Morphine + Intranasal Placebo

• Registration Number: NCT03063359
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-30
• Study First Submitted QC: 2017-02-20
• Study First Posted: 2017-02-24
• Study Start: 2017-05-30
• Primary Completion: 2018-07-18
• Study Completion: 2019-03-12
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-29
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intranasal fentanyl + Oral placebo	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.
Oral morphine + Intranasal placebo	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.

Primary Outcome Measures

Name	Time	Method
Assessment of the value of the pain feeling	45 minutes	Assessment of the value of the pain feeling measured by visual analogic scale

Secondary Outcome Measures

Name	Time	Method
Delay in treatment efficacy	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.

Trial Locations

Locations (1)

University hospital of Montpellier; 🇫🇷 Montpellier, France