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

Phase 4

Completed

• Conditions: Pain
• Interventions: Drug: Tramadol IV (Tradonal® IV); Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)

• Registration Number: NCT00735748
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-01
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2008-08-14
• Study First Posted: 2008-08-15
• Primary Completion: 2009-06-19
• Study Completion: 2009-06-19
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Tramadol IV (Tradonal® IV)	Tramadol IV (Tradonal® IV)
1	Tramadol per os (Tradonal Odis® orodispersible tablets)	Tramadol per os (Tradonal Odis® orodispersible tablets)

Primary Outcome Measures

Name	Time	Method
Difference in pain score between groups	In the first hours after anaesthesia and surgery

Secondary Outcome Measures

Name	Time	Method
Difference in side-effects between the groups	In the first hours after anaesthesia and surgery

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium