CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 35 enrolled
Drug / intervention
Hydromorphonedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02437669
NCT02437669Phase 2Completed

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

Columbia University·interventional·Posted May 7, 2015·Updated May 28, 2019

In Brief

A Phase 2 clinical trial evaluating Hydromorphone for Pain. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 7, 2015
Enrollment StartMay 1, 2015
Primary CompletionApr 1, 2018
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.2 years ago

Interventions

Hydromorphonedrug

To be administered by intranasal route using mucosal atomization device.