Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-Operative Treatment With Ketorolac After Abdominal Myomectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00845754
Recruitment Status : Completed
First Posted : February 18, 2009
Last Update Posted : February 18, 2009
Sponsor:
Collaborators:
New York Presbyterian Hospital
Icahn School of Medicine at Mount Sinai
Information provided by:
Ascher-Walsh, Charles, M.D.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Febrile Morbidity Pain Drug: ketorolac Drug: saline Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effects of Ketorolac on Post-Operative Febrile Morbidity and Pain Management in Abdominal Myomectomy Patients
Study Start Date : September 1999
Actual Primary Completion Date : August 2001
Actual Study Completion Date : August 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Ketorolac

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Post-operative febrile morbidity [ Time Frame: Inital 24hrs post-operative ]

Secondary Outcome Measures :
  1. Post-operative pain management [ Time Frame: Initial 24hrs post-operative ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00845754


Locations
Layout table for location information
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
Icahn School of Medicine at Mount Sinai
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Charles Ascher-Walsh MD, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT00845754     History of Changes
Other Study ID Numbers: ASW 124
First Posted: February 18, 2009    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009
Keywords provided by Ascher-Walsh, Charles, M.D.:
Post-operative febrile morbidity
Post-operative pain management
Additional relevant MeSH terms:
Layout table for 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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action