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NCT02437669 · ClinicalTrials.gov registry record · Phase 2
Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.
A Phase 2 study, sponsored by Columbia University.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT02437669: Completed Phase 2 study, sponsored by Columbia University.
NCT02437669 is a Phase 2 study that has completed, run by Columbia University. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02437669, a Phase 2 study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study 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.
Primary Outcome
Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents "very much pain" (i.e. maximum possible pain). More information about the FP
Interventions
- DRUG Hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2015-05 |
| Est. Completion | 2018-04 |
| Phase | Phase 2 |
What the finished NCT02437669 record still lists
NCT02437669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydromorphone is the first listed.
NCT02437669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02437669 about?
NCT02437669 is a clinical study titled "Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.". 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 prosp...
What is the current status of trial NCT02437669?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2015-05. Estimated completion is 2018-04.
What interventions are being tested in trial NCT02437669?
The interventions under investigation include: Hydromorphone (DRUG).
Who is sponsoring clinical trial NCT02437669?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02437669's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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