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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00333346
Enrollment
200
Registered
2006-06-05
Start date
2006-09-30
Completion date
2009-04-30
Last updated
2010-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Surgery

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.

Interventions

DRUGAdministration of tramadol intravenously

Sponsors

University Hospital, Ghent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Time course of pain relief
Accuracy of pain relief
Onset of side-effects
Duration of side-effects

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026