Post-Operative Treatment With Ketorolac After Abdominal Myomectomy

This study has been completed.
Sponsor:
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
  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 April 21, 2014