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. |
- Difference in pain score between groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: No ]
- 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
Tramadol and Pain Sensitization (TRAMADOL)
Purpose
Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.
| Condition | Intervention | Phase |
| Pain | Drug: Tramadol | Phase I |
| Drug Information available for: | Tramadol hydrochloride Tramadol |
U.S. FDA Resources
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
| Official Title: | Tramadol and Pain Sensitization |
- Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area [ Time Frame: with an induced hyperalgic area ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 12 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2007 |
| Estimated Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
- Drug: Tramadol
Detailed Description:
The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment
Tags: Amplitude, cold stimulus, Pain, placebo, sensitization, Tramadol
