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.”

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.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)
  • Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
• Drug: Tramadol IV (Tradonal® IV)
  • Administration of tramadol IV given in 3 unit dosage of 35 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Tramadol per os (Tradonal Odis® orodispersible tablets)
• Active Comparator: 2
  • Tramadol IV (Tradonal® IV)

Primary Measures

• Difference in pain score between groups
  • Time Frame: In the first hours after anaesthesia and surgery
    Safety Issue?: No

Secondary Measures

• Difference in side-effects between the groups
  • Time Frame: In the first hours after anaesthesia and surgery
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University Hospital, Ghent

Overall Clinical Trial Officials and Contacts

Michel Struys, MD, PhD Principal Investigator University Hospital, Ghent  

Overall Contact: Michel Struys, MD, PhD  Michel.struys@ugent.be

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00735748

Study ID Number: 2007/526

ClinicalTrials.gov Identifier: NCT00735748

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Website of the University Hospital Ghent