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NCT00735748 Clinical Trial

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

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00735748
Other study ID # 2007/526
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 1, 2008
Est. completion date June 19, 2009

Study information
Verified date January 2023
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 195
Est. completion date June 19, 2009
Est. primary completion date June 19, 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Difference in pain score between groups In the first hours after anaesthesia and surgery
Secondary Difference in side-effects between the groups In the first hours after anaesthesia and surgery
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