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

Sponsor:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00735748

Purpose

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.

Condition	Intervention	Phase
Pain	Drug: Tramadol per os (Tradonal Odis® orodispersible tablets) Drug: Tramadol IV (Tradonal® IV)	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Therapeutic Efficacy and Side Effects of Tramadol Per os (Tradonal Odis® Orodispersible Tablets) Versus an Optimised Dosis of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery.

Resource links provided by NLM:

MedlinePlus related topics: Surgery

Drug Information available for: Tramadol

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:

Difference in pain score between groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Difference in side-effects between the groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Tramadol per os (Tradonal Odis® orodispersible tablets)	Drug: Tramadol per os (Tradonal Odis® orodispersible tablets) Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
2: Active Comparator Tramadol IV (Tradonal® IV)	Drug: Tramadol IV (Tradonal® IV) Administration of tramadol IV given in 3 unit dosage of 35 mg

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 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735748

Contacts

Contact: Michel Struys, MD, PhD

Michel.struys@ugent.be

Locations

Belgium
University Hospital Ghent	Recruiting
Ghent, Belgium, 9000
Contact: Oona Sinnaeve Oona.sinnaeve@ugent.be
Principal Investigator: Michel Struys, MD, PhD
Sub-Investigator: Marc Coppens, MD
Sub-Investigator: Bjorn Heyse, MD

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:	2007/526
Study First Received:	August 14, 2008
Last Updated:	April 9, 2009
ClinicalTrials.gov Identifier:	NCT00735748 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by University Hospital, Ghent:

Patients who will undergo a general anesthesia for a procedure in short stay

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 February 08, 2010