drugset / Trial / NCT02437669

Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.

NCT02437669

Phase 2 Completed 35 enrolled Columbia University
NaSingle-groupOpen-labelTreatment

Summary

Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It has not been previously studied in children, but may be a viable option for effectively and safely reducing pain in children by administering an analgesic by the intranasal route. This study will be a prospective, open-label pilot study of intranasal hydromorphone in children with moderate to severe acute pain presenting to the pediatric emergency department. The investigators aim to describe the amount of pain reduction associated with intranasal hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with a clinically meaningful improvement in acute pain.

Timeline

Start
2015-05
Primary completion
2018-04
Completion
2018-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydromorphone Other / unclassified 0.03 mg/kg Intranasal
Subject Hydromorphone Other / unclassified 0.045 mg/kg Intranasal
Subject Hydromorphone Other / unclassified 0.06 mg/kg Intranasal

Indications

No indication recorded.