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NCT00693160 · ClinicalTrials.gov registry record · Phase 2
Effect of Spinal Ketorolac After Acute Opioid Exposure
A Phase 2 study, sponsored by Wake Forest University.
- Terminated
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT00693160: Clinical Trial Phase 2 study, sponsored by Wake Forest University.
NCT00693160 is a Phase 2 study that was terminated before completion, run by Wake Forest University. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00693160, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous \[IV\] narcotic painkiller): 1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream? 2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?
Primary Outcome
Total Area of hypersensitivity (measured in centimeters) were assessed approximately 24 hours post intrathecal ketorolac injection by the method of using a von Frey filament
Interventions
- DRUG placebo
- DRUG ketorolac
- DRUG Capsaicin
- DRUG remifentanil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-12 |
| Est. Completion | 2011-01 |
| Phase | Phase 2 |
Why NCT00693160 stopped before completion
NCT00693160 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which placebo is the first listed.
NCT00693160 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00693160 about?
NCT00693160 is a clinical study titled "Effect of Spinal Ketorolac After Acute Opioid Exposure". This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and compli...
What is the current status of trial NCT00693160?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2007-12. Estimated completion is 2011-01.
What interventions are being tested in trial NCT00693160?
The interventions under investigation include: placebo (DRUG), ketorolac (DRUG), Capsaicin (DRUG), remifentanil (DRUG).
Who is sponsoring clinical trial NCT00693160?
This trial is sponsored by Wake Forest University, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00693160's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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