Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery
Information source: University Hospital, Ghent
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ambulatory Surgery
Intervention: Administration of tramadol intravenously (Drug)
Phase: Phase 2
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, Phone: 0032/(0)9/240.49.55, Email: michel.struys@UGent.be
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.
Clinical Details
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 design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Primary outcome: Time course of pain reliefAccuracy of pain relief Onset of side-effects Duration of side-effects
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Michel Struys, MD, PhD, Phone: 0032/(0)9/240.49.55, Email: michel.struys@UGent.be
University Hospital Ghent, Ghent 9000, Belgium; Recruiting
Michel Struys, MD, PhD, Phone: 0032/(0)9/240.49.55, Email: michel.struys@UGent.be
Michel Struys, MD, PhD, Principal Investigator
Additional Information
Website of the University Hospital Ghent
Starting date: September 2006
Last updated: December 19, 2007
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