Oxycodone vs Fentanyl for Pain Treatment After Laparoscopic Cholecystectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

August 28, 2006

Last Updated Date

November 16, 2007

Start Date ^ICMJE

August 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pain intensity

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00369811 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Oxycodone vs Fentanyl for Pain Treatment After Laparoscopic Cholecystectomy

Official Title ^ICMJE

Comparative Study of Oxycodone and Fentanyl Given Intravenously in the Treatment of Early Postoperative Pain After Laparoscopic Cholecystectomy

Brief Summary

To evaluate the analgesic efficacy of oxycodone and fentanyl in the treatment of postoperative pain after laparoscopic cholecystectomy.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Oxycodone, fentanyl

Study Arms / Comparison Groups

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

Estimated Enrollment ^ICMJE

Completion Date

September 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Planned outpatient laparoscopic cholecystectomy
>18 years

Exclusion Criteria:

Intolerance to study drugs
Treatment with MAO inhibitors

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT ID ^ICMJE

NCT00369811

Responsible Party

Study ID Numbers ^ICMJE

OXFEN2006

Study Sponsor ^ICMJE

Danish Pain Research Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Lone Nikolajsen, MD, PhD

Danish Pain Research Center, Aarhus University Hospital

Information Provided By

Danish Pain Research Center

Verification Date

November 2007

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