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Completed

NCT Number: NCT00333346

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

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.

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Key information

Conditions

Ambulatory Surgery

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Administration of tramadol intravenously

Drug

Primary outcomes

  1. Time course of pain relief

  2. Accuracy of pain relief

  3. Onset of side-effects

  4. Duration of side-effects

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jun 5, 2006
Registry last updated
Aug 31, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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