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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Pain

Intervention / Treatment
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* Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)
* Drug: Tramadol IV (Tradonal® IV)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tramadol per os (Tradonal Odis® orodispersible tablets) | Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)<br>* Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages<br>|
| Active Comparator: 2<br>Tramadol IV (Tradonal® IV) | Drug: Tramadol IV (Tradonal® IV)<br>* Administration of tramadol IV given in 3 unit dosage of 35 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in pain score between groups |  | In the first hours after anaesthesia and surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in side-effects between the groups |  | In the first hours after anaesthesia and surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients who will undergo a general anesthesia for a procedure in short stay