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

This study is currently recruiting participants.

Verified by University Hospital, Ghent, April 2009

First Received: June 2, 2006 Last Updated: April 9, 2009 History of Changes

Sponsor:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00333346

Purpose

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.

Condition	Intervention	Phase
Ambulatory Surgery	Drug: Administration of tramadol intravenously	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Tramadol Tramadol hydrochloride

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Time course of pain relief
Accuracy of pain relief
Onset of side-effects
Duration of side-effects

Estimated Enrollment:	200
Study Start Date:	September 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00333346

Contacts

Contact: Michel Struys, MD, PhD

+ 32 9 332.49.55

michel.struys@UGent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Michel Struys, MD, PhD + 32 9 332.49.55 michel.struys@UGent.be
Principal Investigator: Michel Struys, MD, PhD

Sponsors and Collaborators

University Hospital, Ghent

Investigators

Principal Investigator:

Michel Struys, MD, PhD

University Hospital, Ghent

More Information

Additional Information:

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Hospital Ghent ( Michel Struys )
Study ID Numbers:	2006/195
Study First Received:	June 2, 2006
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00333346 History of Changes
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Tramadol
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pain
Pharmacologic Actions
Signs and Symptoms
Pathologic Processes

Postoperative Complications
Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Pain, Postoperative
Analgesics, Opioid

ClinicalTrials.gov processed this record on November 27, 2009