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

• Status: Completed
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Treatments: Hydromorphone

Criteria

Inclusion Criteria:

• Age 4 to 17 years old, inclusive

• Moderate to severe pain (i.e. FPS-R or vNRS score of 4 or more)

• Requires parenteral opioid analgesic to treat their pain, as decided by treating physician

Exclusion Criteria:

• Allergy or known contraindication to receiving opioids

• Receipt of any opioid or benzodiazepine within preceding 6 hours

• Presence of intranasal obstruction that cannot be cleared readily

• Cannot speak English or Spanish

• Patient unlikely to be able to complete self-report measures of pain or questionnaires

• Known liver or kidney problems

• Currently critically ill

• Chronic pain condition (e.g. sickle cell disease, fibromyalgia)