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Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery

Primary Purpose

Pain

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Tramadol per os (Tradonal Odis® orodispersible tablets)
Tramadol IV (Tradonal® IV)
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Patients who will undergo a general anesthesia for a procedure in short stay

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I and II female or male patients undergoing wisdom teeth extraction
  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Tramadol per os (Tradonal Odis® orodispersible tablets)

Tramadol IV (Tradonal® IV)

Outcomes

Primary Outcome Measures

Difference in pain score between groups

Secondary Outcome Measures

Difference in side-effects between the groups

Full Information

First Posted
August 14, 2008
Last Updated
January 5, 2023
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT00735748
Brief Title
Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery
Official Title
Comparison of the Therapeutic Efficacy and Side Effects of Tramadol Per os (Tradonal Odis® Orodispersible Tablets) Versus an Optimised Dosis of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2008 (Actual)
Primary Completion Date
June 19, 2009 (Actual)
Study Completion Date
June 19, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Patients who will undergo a general anesthesia for a procedure in short stay

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Tramadol per os (Tradonal Odis® orodispersible tablets)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Tramadol IV (Tradonal® IV)
Intervention Type
Drug
Intervention Name(s)
Tramadol per os (Tradonal Odis® orodispersible tablets)
Intervention Description
Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
Intervention Type
Drug
Intervention Name(s)
Tramadol IV (Tradonal® IV)
Intervention Description
Administration of tramadol IV given in 3 unit dosage of 35 mg
Primary Outcome Measure Information:
Title
Difference in pain score between groups
Time Frame
In the first hours after anaesthesia and surgery
Secondary Outcome Measure Information:
Title
Difference in side-effects between the groups
Time Frame
In the first hours after anaesthesia and surgery

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 undergoing wisdom teeth extraction 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

Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery

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