Back to resultsPost-Operative Treatment With Ketorolac After Abdominal Myomectomy
Primary Purpose
Febrile Morbidity, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ketorolac
saline
Sponsored by
About this trial
This is an interventional treatment trial for Febrile Morbidity focused on measuring Post-operative febrile morbidity, Post-operative pain management
Eligibility 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
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
1
2
Arm Description
Placebo
Ketorolac
Outcomes
Primary Outcome Measures
Post-operative febrile morbidity
Secondary Outcome Measures
Post-operative pain management
Full Information
NCT ID
NCT00845754
First Posted
February 14, 2009
Last Updated
February 17, 2009
Sponsor
Ascher-Walsh, Charles, M.D.
Collaborators
New York Presbyterian Hospital, Icahn School of Medicine at Mount Sinai
1. Study Identification
Unique Protocol Identification Number
NCT00845754
Brief Title
Post-Operative Treatment With Ketorolac After Abdominal Myomectomy
Official Title
Effects of Ketorolac on Post-Operative Febrile Morbidity and Pain Management in Abdominal Myomectomy Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
September 1999 (undefined)
Primary Completion Date
August 2001 (Actual)
Study Completion Date
August 2001 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Ascher-Walsh, Charles, M.D.
Collaborators
New York Presbyterian Hospital, Icahn School of Medicine at Mount Sinai
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Febrile Morbidity, Pain
Keywords
Post-operative febrile morbidity, Post-operative pain management
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
112 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
2
Arm Type
Active Comparator
Arm Description
Ketorolac
Intervention Type
Drug
Intervention Name(s)
ketorolac
Other Intervention Name(s)
Toradol
Intervention Description
15mg IV every6 hours for 4doses
Intervention Type
Drug
Intervention Name(s)
saline
Intervention Description
15mg IV every 6hrs for 4 doses
Primary Outcome Measure Information:
Title
Post-operative febrile morbidity
Time Frame
Inital 24hrs post-operative
Secondary Outcome Measure Information:
Title
Post-operative pain management
Time Frame
Initial 24hrs post-operative
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Post-Operative Treatment With Ketorolac After Abdominal Myomectomy
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