Ambulatory surgery
Conditions
Interventions
Trade Name: Tradonal Odis
Product Name: Tradonal Odis
Pharmaceutical Form: Orodispersible tablet
INN or Proposed INN: TRAMADOL
CAS Number: 27203925
Concentration unit: mg milligram(s)
Concentration ty
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion 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. 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
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim 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. ;Secondary Objective: ;Primary end point(s): Pain relief Duration of side effects | — |
Countries
Belgium
Outcome results
None listed