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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.

Tracking Information
First Submitted Date  ICMJE February 14, 2009
First Posted Date  ICMJE February 18, 2009
Last Update Posted Date February 18, 2009
Study Start Date  ICMJE September 1999
Actual Primary Completion Date August 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Post-operative febrile morbidity [ Time Frame: Inital 24hrs post-operative ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Post-operative pain management [ Time Frame: Initial 24hrs post-operative ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Post-Operative Treatment With Ketorolac After Abdominal Myomectomy
Official Title  ICMJE Effects of Ketorolac on Post-Operative Febrile Morbidity and Pain Management in Abdominal Myomectomy Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE
  • Febrile Morbidity
  • Pain
Intervention  ICMJE
  • Drug: ketorolac
    15mg IV every6 hours for 4doses
    Other Name: Toradol
  • Drug: saline
    15mg IV every 6hrs for 4 doses
Study Arms  ICMJE
  • Placebo Comparator: 1
    Placebo
    Intervention: Drug: saline
  • Active Comparator: 2
    Ketorolac
    Intervention: Drug: ketorolac
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2009)
112
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2001
Actual Primary Completion Date August 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00845754
Other Study ID Numbers  ICMJE ASW 124
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles Ascher-Walsh MD, Mount Sinai School of Medicine
Study Sponsor  ICMJE Ascher-Walsh, Charles, M.D.
Collaborators  ICMJE
  • New York Presbyterian Hospital
  • Icahn School of Medicine at Mount Sinai
Investigators  ICMJE Not Provided
PRS Account Ascher-Walsh, Charles, M.D.
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP