Comparison of the therapeutic efficacy and side effects of tramadol per os (Tradonal Odis® orodispersible tablets) versus an optimised dosis of travenous tramadol for postoperative pain relief in ambulatory surgery.
- Conditions
- Ambulatory surgery
- Registration Number
- EUCTR2007-007019-10-BE
- Lead Sponsor
- niversity Hospital Ghent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 200
ASA I and II female or male patients undergoing wisdom teeth extraction, aged 18-70 years, scheduled for ambulatory surgery requiring postoperative pain medication.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria included weight less than 70% or more than 130% of ideal body weight, neurological disorder, and 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.
Patients who do not reach a VAS score of 4 or more at PACU arrival will be considered as screening failure and will not be randomized. (They will be replaced by another subject.).
In the group receiving tramadol perorally, patients will be excluded if they vomit within 1 hours post administration due to the fact that the tramadol dose might not have been absorbed completely hereby increasing intra-individual variability.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method