ASA I and II
Conditions
Interventions
Product Name: Tramadol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Tramadol.chlorhydr.
CAS Number: 22204-88-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concent
Sponsors
University Hospital Ghent
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ASA I and II female or male patients, 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: ;Primary end point(s): Pain score (VAS) Alertness score (Aldrete score) Classification of post-operative nausea and vomiting Other side-effects | — |
Countries
Belgium
Outcome results
None listed