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

NCT ID: NCT00735748

Last Updated: 2023-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-01
• Study Completion Date: 2009-06-19

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Tramadol per os (Tradonal Odis® orodispersible tablets)

Group Type: EXPERIMENTAL

Tramadol per os (Tradonal Odis® orodispersible tablets)

Intervention Type: DRUG

Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages

2

Tramadol IV (Tradonal® IV)

Group Type: ACTIVE_COMPARATOR

Tramadol IV (Tradonal® IV)

Intervention Type: DRUG

Administration of tramadol IV given in 3 unit dosage of 35 mg

Interventions

Tramadol per os (Tradonal Odis® orodispersible tablets)

Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages

Intervention Type: DRUG

Tramadol IV (Tradonal® IV)

Administration of tramadol IV given in 3 unit dosage of 35 mg

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ghent

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel Struys, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

University Hospital Ghent

Ghent, , Belgium

Countries

Belgium

Related Links

http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

2007/526

Identifier Type: -

Identifier Source: org_study_id