Overview

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

Status:
Unknown status
Trial end date:
2015-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Ghent
Treatments:
Tramadol
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