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NCT01133639 · ClinicalTrials.gov registry record · NA
Ketorolac Effects on Post-operative Pain and Bone Healing
A NA study, sponsored by Beth Israel Deaconess Medical Center.
- Terminated
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT01133639 is a NA study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 18 participants.
The verdict
NCT01133639, a NA study, was terminated before completion, sponsored by Beth Israel Deaconess Medical Center.
- TERMINATED
- Registry status
- NA
- Development phase
- 18 participants
- Enrollment target
Study Summary
This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days) plus standard of care or placebo plus standard of care. The purpose of this study is to evaluate the effects of ketorolac plus standard of care on post-operative pain control and radiographic osseous healing. Patients will be assessed for pain via a validated pain questionnaire and for delayed unions via a radiographic scoring system shown to have both high inter- and intra-observer reliability by a blinded board certified radiologist. Additional outcomes of bunionectomy procedures will also be evaluated including adverse events and time to regular shoe gear and activities.
Interventions
- DRUG Placebo
- DRUG Ketorolac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01133639
The ClinicalTrials.gov registry entry for NCT01133639 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Beth Israel Deaconess Medical Center, which has 488 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01133639 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01133639 about?
NCT01133639 is a clinical study titled "Ketorolac Effects on Post-operative Pain and Bone Healing". This will be a randomized double-blind placebo-controlled clinical trial that will accept all eligible consecutive patients undergoing elective Kalish bunionectomies. Patients will be randomized into either receiving ketorolac (30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours f...
What is the current status of trial NCT01133639?
This trial is currently terminated. It is a NA study. The enrollment target is 18 participants. The study started on 2010-05. Estimated completion is 2012-02.
What interventions are being tested in trial NCT01133639?
The interventions under investigation include: Placebo (DRUG), Ketorolac (DRUG).
Who is sponsoring clinical trial NCT01133639?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
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