Post-Operative Treatment With Ketorolac After Abdominal Myomectomy
This study has been completed.
Sponsor:
Ascher-Walsh, Charles, M.D.
Collaborators:
New York Presbyterian Hospital
Mount Sinai School of Medicine
Information provided by:
Ascher-Walsh, Charles, M.D.
ClinicalTrials.gov Identifier:
NCT00845754
First received: February 14, 2009
Last updated: February 17, 2009
Last verified: February 2009
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Purpose
The purpose of this study is to determine if ketorolac, given after abdominal myomectomy, will decrease the frequency of post-oerative fevers as well as improve post-operative pain management.
| Condition | Intervention |
|---|---|
|
Febrile Morbidity Pain |
Drug: ketorolac Drug: saline |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Treatment |
| Official Title: | Effects of Ketorolac on Post-Operative Febrile Morbidity and Pain Management in Abdominal Myomectomy Patients |
Resource links provided by NLM:
Further study details as provided by Ascher-Walsh, Charles, M.D.:
Primary Outcome Measures:
- Post-operative febrile morbidity [ Time Frame: Inital 24hrs post-operative ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Post-operative pain management [ Time Frame: Initial 24hrs post-operative ]
| Enrollment: | 112 |
| Study Start Date: | September 1999 |
| Study Completion Date: | August 2001 |
| Primary Completion Date: | August 2001 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: 1
Placebo
|
Drug: saline
15mg IV every 6hrs for 4 doses
|
|
Active Comparator: 2
Ketorolac
|
Drug: ketorolac
15mg IV every6 hours for 4doses
Other Name: Toradol
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Ant patient undregoing abdominal myomectomy
Exclusion Criteria:
- Patients with contraindication to NSAIDs including history of peptic ulcer disease, renal disease, bleeding diathesis, or hypersensitivity to NSAIDS
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845754
Locations
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
Sponsors and Collaborators
Ascher-Walsh, Charles, M.D.
New York Presbyterian Hospital
Mount Sinai School of Medicine
More Information
No publications provided
| Responsible Party: | Charles Ascher-Walsh MD, Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00845754 History of Changes |
| Other Study ID Numbers: | ASW 124 |
| Study First Received: | February 14, 2009 |
| Last Updated: | February 17, 2009 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Ascher-Walsh, Charles, M.D.:
|
Post-operative febrile morbidity Post-operative pain management |
Additional relevant MeSH terms:
|
Fever Body Temperature Changes Signs and Symptoms Ketorolac Ketorolac Tromethamine Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013