Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery
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.
| Condition | Intervention | Phase |
| Pain | Drug: Tramadol per os (Tradonal Odis® orodispersible tablets) Drug: Tramadol IV (Tradonal® IV) |
Phase IV |
| Drug Information available for: | Tramadol hydrochloride Tramadol |
U.S. FDA Resources
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison of the Therapeutic Efficacy and Side Effects of Tramadol Per os (Tradonal Odis® Orodispersible Tablets) Versus an Optimised Dosis of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery. |
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Difference in pain score between groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Difference in side-effects between the groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| 1: Experimental
Tramadol per os (Tradonal Odis® orodispersible tablets)
|
Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)
Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
|
| 2: Active Comparator
Tramadol IV (Tradonal® IV)
|
Drug: Tramadol IV (Tradonal® IV)
Administration of tramadol IV given in 3 unit dosage of 35 mg
|
Tags: Ambulatory, Pain, Relief, Surgery, Tramadol
