Tramadol iv. : Influence of Dose and Dose Intervals on Therapeutic Accuracy and Side Effects When Used for Postoperative Pain Relief in Ambulatory Surgery

Ambulatory Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00333346
• Other study ID #: 2006/195
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2006
• Last updated: August 30, 2010
• Start date: September 2006
• Est. completion date: April 2009

Study information

• Verified date: August 2010
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ambulatory Surgery
• Pain, Postoperative

Intervention

Drug:
• Administration of tramadol intravenously

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time course of pain relief
Primary	Accuracy of pain relief
Primary	Onset of side-effects
Primary	Duration of side-effects

External Links

•   Website of the University Hospital Ghent