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

University Hospital, Ghent195 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

195

Conditions

Pain

Interventions

Tramadol per os (Tradonal Odis® orodispersible tablets)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Difference in pain score between groups

Time frame: In the first hours after anaesthesia and surgery

Secondary Outcomes

Difference in side-effects between the groups