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

Phase 2

Completed

• Conditions: Ambulatory Surgery

• Registration Number: NCT00333346
• Lead Sponsor: University Hospital, Ghent

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

Not available

Study Timeline

• Study First Submitted: 2006-06-02
• Study First Submitted QC: 2006-06-02
• Study First Posted: 2006-06-05
• Study Start: 2006-09
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-30
• Last Update Posted: 2010-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium