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NCT01892709 · ClinicalTrials.gov registry record · Phase 4
Titration of Intravenous Hydromorphone
A Phase 4 study of Acute Severe Pain, sponsored by Montefiore Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 215
- Enrollment target
- 1
- Study location
NCT01892709: Completed Phase 4 study of Acute Severe Pain, sponsored by Montefiore Medical Center.
NCT01892709 is a Phase 4 study of Acute Severe Pain that has completed, run by Montefiore Medical Center. The registered enrollment target is 215 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01892709, a Phase 4 study of Acute Severe Pain, has completed, sponsored by Montefiore Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 215 participants
- Enrollment target
- 1
- Study location
Study Summary
This is an exploratory, hypothesis-generating safety and efficacy study for patients who come to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic pain will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV hydromorphone over a 4 hour period. Hydromorphone will be given as 1 mg increments based on how the patient responds to the question, "Do you want more pain medicine?". This question will be asked repeatedly 30 minutes after the patient answers "no" or 30 minutes after the most recent dose of IV hydromorphone (which occurs if the patient answers "yes"). Up to 10% (approximately 30 patients) will serve as a pilot at the start of the study.
Primary Outcome
This is a descriptive hypothesis-generating trial, which is why it is not being compared in a randomized fashion to a comparison group. We are examining extended titration by expanding our "1+1" protocol to a "1+1+1+1" protocol and the various patterns of opioid request. For example, some may state "no" every time they are asked "Do you want more pain medication?" Some will state "yes" each time, and others will answer "yes" and "no" at different time periods. We will report these various patter
Conditions Studied
Interventions
- DRUG Hydromorphone
Study Locations (1)
New York
- Montefiore Medical Center Moses Emegency Department - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-04 |
| Phase | Phase 4 |
What the finished NCT01892709 record still lists
NCT01892709 is an interventional study that assigns participants to a tested intervention. The registered 215 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 (58% lower).
The record links to 1 condition, with Acute Severe Pain appearing as the primary indexed condition, and to 1 intervention - of which Hydromorphone is the first listed.
NCT01892709 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01892709 about?
NCT01892709 is a clinical study titled "Titration of Intravenous Hydromorphone". This is an exploratory, hypothesis-generating safety and efficacy study for patients who come to the ER in acute (less than 7 days in duration) severe pain. Patients with chronic pain will not be enrolled. Eligible patients will receive up to a maximum of 4 mg IV hydromorphone over a 4 hour period. ...
What is the current status of trial NCT01892709?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 215 participants. The study started on 2013-06. Estimated completion is 2014-04.
What conditions does trial NCT01892709 study?
This clinical trial studies the following conditions: Acute Severe Pain.
What interventions are being tested in trial NCT01892709?
The interventions under investigation include: Hydromorphone (DRUG).
Who is sponsoring clinical trial NCT01892709?
This trial is sponsored by Montefiore Medical Center, which has 345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01892709 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01892709's enrollment target sits among peer trials
215 394th of 2000 higher than 1,607 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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