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NCT01591382 · ClinicalTrials.gov registry record · Phase 4
Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients
A Phase 4 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 64
- Enrollment target
NCT01591382: Completed Phase 4 study, sponsored by Brigham and Women's Hospital.
NCT01591382 is a Phase 4 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 64 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01591382, a Phase 4 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 64 participants
- Enrollment target
Study Summary
Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.
Primary Outcome
Postoperative pain scores were collected once per day during morning rounds for the preceding 24 hours. Participant were asked to provide pain scores for "worst," "average," and "least" pain using the 11-point Numerical Rating Scale (NRS), where 0 represents the absence of pain and 10 is worst possible pain. The average postoperative pain score for each treatment arm is reported.
Interventions
- DRUG Placebo
- DRUG Ketamine
- DRUG Hydromorphone PCA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2008-09 |
| Est. Completion | 2012-06 |
| Phase | Phase 4 |
What the finished NCT01591382 record still lists
NCT01591382 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01591382 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01591382 about?
NCT01591382 is a clinical study titled "Efficacy Study of Ketamine for Postoperative Pain in Opioid Dependent Patients". Patients who are dependent on opioids often have poor pain relief after major surgery. This study tests the hypothesis that adding intravenous ketamine to a postoperative regimen of intravenous opioids for postoperative pain will improve pain relief in this subset of patients.
What is the current status of trial NCT01591382?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 64 participants. The study started on 2008-09. Estimated completion is 2012-06.
What interventions are being tested in trial NCT01591382?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), Hydromorphone PCA (DRUG).
Who is sponsoring clinical trial NCT01591382?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01591382's enrollment target sits among peer trials
64 1098th of 2000 higher than 895 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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