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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

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ClinicalTrials.gov Identifier: NCT00333346
Recruitment Status : Completed
First Posted : June 5, 2006
Last Update Posted : August 31, 2010
Sponsor:
Information provided by:
University Hospital, Ghent

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.

Condition or disease Intervention/treatment Phase
Ambulatory Surgery Drug: Administration of tramadol intravenously Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2006
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol
U.S. FDA Resources




Primary Outcome Measures :
  1. Time course of pain relief
  2. Accuracy of pain relief
  3. Onset of side-effects
  4. Duration of side-effects


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333346


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Michel Struys, MD, PhD University Hospital, Ghent

Additional Information:
Responsible Party: Michel Struys, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00333346     History of Changes
Other Study ID Numbers: 2006/195
First Posted: June 5, 2006    Key Record Dates
Last Update Posted: August 31, 2010
Last Verified: August 2010

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Tramadol
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents