Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery
This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
University Hospital, Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00735748
First received: August 14, 2008
Last updated: January 29, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during the first 6 hours postoperatively and to investigate the time course and accuracy of pain relief versus the onset and duration of side effects. The first unit dose will be administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is reached. The second and third unit dose will be administered after 1 and 2 hours, respectively, when a VAS of more than 3 is observed.
| Condition | Intervention | Phase |
|---|---|---|
|
Pain |
Drug: Tramadol per os (Tradonal Odis® orodispersible tablets) Drug: Tramadol IV (Tradonal® IV) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Comparison of the Therapeutic Efficacy and Side Effects of Tramadol Per os (Tradonal Odis® Orodispersible Tablets) Versus an Optimised Dosis of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery. |
Resource links provided by NLM:
Further study details as provided by University Hospital, Ghent:
Primary Outcome Measures:
- Difference in pain score between groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Difference in side-effects between the groups [ Time Frame: In the first hours after anaesthesia and surgery ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 200 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Tramadol per os (Tradonal Odis® orodispersible tablets)
|
Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)
Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
|
|
Active Comparator: 2
Tramadol IV (Tradonal® IV)
|
Drug: Tramadol IV (Tradonal® IV)
Administration of tramadol IV given in 3 unit dosage of 35 mg
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- ASA I and II female or male patients undergoing wisdom teeth extraction
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735748
Contacts
| Contact: Michel Struys, MD, PhD | Michel.struys@ugent.be |
Locations
| Belgium | |
| University Hospital Ghent | Recruiting |
| Ghent, Belgium, 9000 | |
| Principal Investigator: Michel Struys, MD, PhD | |
| Sub-Investigator: Marc Coppens, MD | |
| Sub-Investigator: Bjorn Heyse, MD | |
Sponsors and Collaborators
University Hospital, Ghent
Investigators
| Principal Investigator: | Michel Struys, MD, PhD | University Hospital, Ghent |
More Information
Additional Information:
No publications provided
| Responsible Party: | University Hospital, Ghent |
| ClinicalTrials.gov Identifier: | NCT00735748 History of Changes |
| Other Study ID Numbers: | 2007/526 |
| Study First Received: | August 14, 2008 |
| Last Updated: | January 29, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Keywords provided by University Hospital, Ghent:
|
Patients who will undergo a general anesthesia for a procedure in short stay |
Additional relevant MeSH terms:
|
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Signs and Symptoms Tramadol Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Pharmacologic Actions Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 19, 2013