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

Ghent University Hospital (UZ)

Status and phase

Completed

Phase 4

Conditions

Pain

Treatments

Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)

Drug: Tramadol IV (Tradonal® IV)

Study type

Interventional

Funder types

Other

Identifiers

NCT00735748

2007/526

Details and patient eligibility

About

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.

Enrollment

195 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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