Back to resultsTramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery
Primary Purpose
Ambulatory Surgery
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Administration of tramadol intravenously
Sponsored by
About this trial
This is an interventional treatment trial for Ambulatory Surgery
Eligibility Criteria
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
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
Time course of pain relief
Accuracy of pain relief
Onset of side-effects
Duration of side-effects
Secondary Outcome Measures
Full Information
NCT ID
NCT00333346
First Posted
June 2, 2006
Last Updated
August 30, 2010
Sponsor
University Hospital, Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00333346
Brief Title
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
Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ambulatory Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Administration of tramadol intravenously
Primary Outcome Measure Information:
Title
Time course of pain relief
Title
Accuracy of pain relief
Title
Onset of side-effects
Title
Duration of side-effects
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Struys, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery
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