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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: Clinical Trial NA study, sponsored by Beth Israel Deaconess Medical Center.
NCT01133639 is a NA study that was terminated before completion, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 18 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
18 subjects were enrolled \& completed the study. Pharmacy held the randomization table. PI left institution \& was never unblinded (because there were never any AEs). Therefore, do not know which subjects were in the placebo vs ketorolac arms. Study was terminated due to lack of administrative support 2/2012 \& all data has been destroyed.
Interventions
- DRUG Placebo
- DRUG Ketorolac
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2010-05 |
| Est. Completion | 2012-02 |
| Phase | NA |
Why NCT01133639 stopped before completion
NCT01133639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01133639 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01133639's enrollment target sits among peer trials
18 1863rd of 2000 higher than 130 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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