Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery
Information source: University Hospital, Ghent
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Tramadol per os (Tradonal Odis® orodispersible tablets) (Drug); Tramadol IV (Tradonal® IV) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital, Ghent Official(s) and/or principal investigator(s):
Michel Struys, MD, PhD, Principal Investigator, Affiliation: University Hospital, Ghent
Overall contact:
Michel Struys, MD, PhD, Email: Michel.struys@ugent.be
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Difference in pain score between groups
Secondary outcome: Difference in side-effects between the groups
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Michel Struys, MD, PhD, Email: Michel.struys@ugent.be
University Hospital Ghent, Ghent 9000, Belgium; Recruiting
Oona Sinnaeve, Email: Oona.sinnaeve@ugent.be
Michel Struys, MD, PhD, Principal Investigator
Marc Coppens, MD, Sub-Investigator
Bjorn Heyse, MD, Sub-Investigator
Additional Information
Website of the University Hospital Ghent
Starting date: March 2008
Ending date: December 2009
Last updated: April 9, 2009
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