Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

June 2, 2006

Last Updated Date

April 9, 2009

Start Date ^ICMJE

September 2006

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time course of pain relief
Accuracy of pain relief
Onset of side-effects
Duration of side-effects

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00333346 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

Official Title ^ICMJE

Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

Brief Summary

The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol intravenously versus multiple smaller dosages of tramadol during the first 6 hours post-operatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side-effects.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study

Condition ^ICMJE

Ambulatory Surgery

Intervention ^ICMJE

Drug: Administration of tramadol intravenously

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

Recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

ASA I and II female or male patients
Aged 18-70 years
Scheduled for ambulatory surgery requiring postoperative pain medication.

Exclusion Criteria:

Weight less than 70% or more than 130% of ideal body weight
Neurological disorder
Recent use of psycho-active medication, including alcohol
Patients suffering from chronic pain receiving pre-operative pain medication including NSAID's
Use of chronic anti-emetic medication, use of chronic corticoid therapy

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Michel Struys, MD, PhD

+ 32 9 332.49.55

michel.struys@UGent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00333346

Responsible Party

Michel Struys, University Hospital Ghent

Study ID Numbers ^ICMJE

2006/195

Study Sponsor ^ICMJE

University Hospital, Ghent

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Michel Struys, MD, PhD

University Hospital, Ghent

Information Provided By

University Hospital, Ghent

Verification Date

April 2009

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