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Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery
This study is currently recruiting participants.
Verified August 2011 by University Hospital, Ghent

First Received on August 14, 2008.   Last Updated on August 16, 2011   History of Changes
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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:

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: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Active Comparator: 2
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: Michel Struys, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00735748     History of Changes
Other Study ID Numbers: 2007/526
Study First Received: August 14, 2008
Last Updated: August 16, 2011
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:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Tramadol
Narcotics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid

ClinicalTrials.gov processed this record on February 09, 2012



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