drugset / Trial / NCT03063359

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

NCT03063359

Phase 3 Terminated 22 enrolled University Hospital, Montpellier
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2017-05-30
Primary completion
2018-07-18
Completion
2019-03-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 1.5 ug/kg Intranasal
Comparator Morphine Other / unclassified 0.4 mg/kg Oral

Indications

No indication recorded.