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

Completed · Phase 2

Conditions studied: Pain

In brief

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.

Key facts

Study ID: NCT02437669
Run by: Columbia University
People needed: 35
Starts: 2015-05-01
Expected to finish: 2018-04-01
Last updated by the study team: 2019-05-28

Who can join

Age: 4 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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)

Where it is running

Morgan Stanley Children's Hospital — New York, New York, United States

Full record on ClinicalTrials.gov

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