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Trial record 73 of 451 for:    TRAMADOL

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

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ClinicalTrials.gov Identifier: NCT00735748
Recruitment Status : Unknown
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : August 15, 2008
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
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 or disease Intervention/treatment Phase
Pain Drug: Tramadol per os (Tradonal Odis® orodispersible tablets) Drug: Tramadol IV (Tradonal® IV) Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : March 2008
Estimated Primary Completion Date : July 2015
Estimated Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tramadol

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Difference in pain score between groups [ Time Frame: In the first hours after anaesthesia and surgery ]

Secondary Outcome Measures :
  1. Difference in side-effects between the groups [ Time Frame: In the first hours after anaesthesia and surgery ]


Information from the National Library of Medicine

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

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): NCT00735748


Contacts
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Contact: Michel Struys, MD, PhD Michel.struys@ugent.be

Locations
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Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Michel Struys, MD, PhD         
Sub-Investigator: Marc Coppens, MD         
Sub-Investigator: Bjorn Heyse, MD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
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Principal Investigator: Michel Struys, MD, PhD University Hospital, Ghent

Additional Information:
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00735748     History of Changes
Other Study ID Numbers: 2007/526
First Posted: August 15, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by University Hospital, Ghent:
Patients who will undergo a general anesthesia for a procedure in short stay
Additional relevant MeSH terms:
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Tramadol
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents