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

NCT00735748 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2023-01-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Principal Investigators

  • Michel Struys, MD, PhD · University Hospital, Ghent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-01
Primary Completion
2009-06-19
Completion
2009-06-19

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00735748 on ClinicalTrials.gov