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

• Status: Terminated
• Trial end date: 2019-03-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Fentanyl; Morphine

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