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

NCT ID: NCT00333346

Last Updated: 2010-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ambulatory Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Administration of tramadol intravenously

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Michel Struys, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2006/195

Identifier Type: -

Identifier Source: org_study_id