drugset / Trial / NCT00735748

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

NCT00735748

Phase 4 Completed 195 enrolled University Hospital, Ghent
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2008-03-01
Primary completion
2009-06-19
Completion
2009-06-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Tramadol Other / unclassified 35 mg Oral
Subject Tramadol Other / unclassified 50 mg Oral

Indications

No indication recorded.