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NCT00682435 · ClinicalTrials.gov registry record · Phase 4
Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients
A Phase 4 study, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 230
- Enrollment target
NCT00682435: Completed Phase 4 study, sponsored by Montefiore Medical Center.
NCT00682435 is a Phase 4 study that has completed, run by Montefiore Medical Center. The registered enrollment target is 230 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00682435, a Phase 4 study, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 230 participants
- Enrollment target
Study Summary
We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone followed by an additional 1mg. Eligible patients will be given 1 mg intravenous (IV) hydromorphone. At 15 minutes, these patients will be asked the question, "Do you need more pain medication?" Those that answer "yes" will receive an additional 1mg IV hydromorphone. Those that answer "no" will not receive additional pain medications at that time period (15 minutes). Thus, we wish to give up to 2 mg IV hydromorphone titrated to patients' pain, which we believe will result in less incidence of oxygen desaturation. If our study shows that this regimen is safe, its efficacy can be assessed in future trials. Positive results of those trials may lead to the use of this regimen to improve pain management in the emergency department.
Primary Outcome
Adequate analgesia is defined as declining additional hydromorphone within 1 hour of entering the protocol
Interventions
- DRUG Hydromorphone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2007-08 |
| Est. Completion | 2007-11 |
| Phase | Phase 4 |
What the finished NCT00682435 record still lists
NCT00682435 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (56% lower).
The record links to 0 conditions, and to 1 intervention - of which Hydromorphone is the first listed.
NCT00682435 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00682435 about?
NCT00682435 is a clinical study titled "Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients". We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone followed by an additional 1mg. Eligible patients will be given 1 mg intravenous (IV) hydromorphone. At 15 minutes, these patients will be asked the question, "Do you need more pain medication?" Those that answer "...
What is the current status of trial NCT00682435?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 230 participants. The study started on 2007-08. Estimated completion is 2007-11.
What interventions are being tested in trial NCT00682435?
The interventions under investigation include: Hydromorphone (DRUG).
Who is sponsoring clinical trial NCT00682435?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00682435's enrollment target sits among peer trials
230 371st of 2000 higher than 1,627 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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