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Clinical Trials/NCT00333346
NCT00333346CompletedPhase 2

Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

University Hospital, Ghent1 site in 1 country200 target enrollmentStarted: September 1, 2006Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
200
Locations
1
Primary Endpoint
Time course of pain relief
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The aim of this study is to compare the administration of 1 unit dose of 100 mg tramadol intravenously versus multiple smaller dosages of tramadol during the first 6 hours post-operatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side-effects.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •ASA I and II female or male patients
  • •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

Outcomes

Primary Outcomes

Time course of pain relief

Accuracy of pain relief

Onset of side-effects

Duration of side-effects

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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