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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 2

Conditions: Ambulatory Surgery

Treatments: Drug: Administration of tramadol intravenously

Study type: Interventional

Funder types: Other

Identifiers

NCT00333346

2006/195

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)