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.

niversity Hospital Ghent0 sites200 target enrollmentDecember 17, 2007

Overview

No summary available.

Registry

who.int

Start Date

December 17, 2007

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity Hospital Ghent

•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.