Pain Post Abdominal Laparoscopy Prevention With Arcoxia - Tabular View

Tracking Information

First Received Date ^ICMJE

November 29, 2007

Last Updated Date

November 29, 2007

Start Date ^ICMJE

April 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

To measure the amount of rescue medication (opioid) needed to relief [ Time Frame: Every hour after surgery ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

To determine the overall analgesic effect using the visual analog scale (VAS) [ Time Frame: Every hour after surgery ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Official Title ^ICMJE

Pain Post Abdominal Laparoscopy Prevention With Arcoxia

Brief Summary

To test the analgesic efficacy of etoricoxib used before a surgical procedure compared to the already known effect when administered after such a procedure. Patient will be receiving either etoricoxib or the respective placebo one hour before surgery, then two hours after those receiving the active will receive placebo and those that received placebo will be given etoricoxib. Pain score measurements will be performed sequentially. Rescue medication will be available all the time.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Laparoscopic Surgery for Appendicitis
Laparoscopic Surgery for Cholecystitis
Laparoscopic Surgery for Ovarian Cysts

Intervention ^ICMJE

Drug: etoricoxib 120 mg

Study Arms / Comparison Groups

Experimental: Etoricoxib 120 mg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Voluntary acceptance to participate in the study and signed the informed consent form
Age older than 18 years old and younger than 70 years
Diagnosis of appendicitis, cholecystitis or ovarian cysts suitable of laparoscopic surgery

Exclusion Criteria:

Age less than 18 years or older than 70 years.
Laparoscopic procedures for diagnostic purposes.
Current use of anticoagulants.
Known hypersensitivity to etoricoxib or its components.
History of a CABG or MI (less than 1 year)
History of unstable angina (over the past six months).
Current inflammatory bowel disease.
Uncontrolled hypertension or heart failure
Renal dysfunction/impairment (creatinine clearance < 30ml/min)
Cirrhosis or severe hepatic dysfunction
Any degree of dehydration (mild to severe)

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00565682

Responsible Party

Eduardo Noboa, Hospital Vozandez

Study ID Numbers ^ICMJE

DOLAAR

Study Sponsor ^ICMJE

Hospital Vozandez

Collaborators ^ICMJE

Merck

Investigators ^ICMJE

Principal Investigator:

Eduardo Noboa, MD

Hospital Vozandez

Information Provided By

Hospital Vozandez

Verification Date

November 2007

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