NCT00333346

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 2, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 5, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 31, 2010

Status Verified

August 1, 2010

Enrollment Period

2.6 years

First QC Date

June 2, 2006

Last Update Submit

August 30, 2010

Conditions

Ambulatory Surgery

Outcome Measures

Primary Outcomes (4)

  • Time course of pain relief

  • Accuracy of pain relief

  • Onset of side-effects

  • Duration of side-effects

Interventions

Administration of tramadol intravenouslyDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I and II female or male patients
  • Aged 18-70 years
  • Scheduled for ambulatory surgery requiring postoperative pain medication.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

Study Officials

  • Michel Struys, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2006

First Posted

June 5, 2006

Study Start

September 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

August 31, 2010

Record last verified: 2010-08

Locations

BE(1)