Post-Operative Treatment With Ketorolac After Abdominal Myomectomy

Pain Clinical Trial

Official title:

Effects of Ketorolac on Post-Operative Febrile Morbidity and Pain Management in Abdominal Myomectomy Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845754
• Other study ID #: ASW 124
• Status: Completed
• Phase: N/A
• First received: February 14, 2009
• Last updated: February 17, 2009
• Start date: September 1999
• Est. completion date: August 2001

Study information

• Verified date: February 2009
• Source: Ascher-Walsh, Charles, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2001
• Est. primary completion date: August 2001
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Febrile Morbidity
• Fever
• Pain

Intervention

Drug:
• ketorolac
15mg IV every6 hours for 4doses
• saline
15mg IV every 6hrs for 4 doses

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Ascher-Walsh, Charles, M.D.	Icahn School of Medicine at Mount Sinai, New York Presbyterian Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative febrile morbidity		Inital 24hrs post-operative	No
Secondary	Post-operative pain management		Initial 24hrs post-operative