PainPhase 4NCT00735748
Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery
A Phase 4 study testing Tramadol per os (Tradonal Odis® orodispersible tablets) and Tramadol IV (Tradonal® IV) in people with Pain, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain
- What is being tested?
- Tramadol per os (Tradonal Odis® orodispersible tablets) and Tramadol IV (Tradonal® IV)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2008to 19 Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I and II female or male patients undergoing wisdom teeth extraction
- Aged 18-70 years
- Scheduled for ambulatory surgery requiring postoperative pain medication
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Pain
- Being tested
- Tramadol per os (Tradonal Odis® orodispersible tablets), Tramadol IV (Tradonal® IV)
- Keywords
- Patients who will undergo a general anesthesia for a procedure in short stay
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tramadol per os (Tradonal Odis® orodispersible tablets)Drug
Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages
Tramadol IV (Tradonal® IV)Drug
Administration of tramadol IV given in 3 unit dosage of 35 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Tramadol per os (Tradonal Odis® orodispersible tablets) Receives: Drug: Tramadol per os (Tradonal Odis® orodispersible tablets) |
| 2 | Active comparator | Tramadol IV (Tradonal® IV) Receives: Drug: Tramadol IV (Tradonal® IV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in pain score between groups
Measured: In the first hours after anaesthesia and surgery
Secondary outcomes (1)
Difference in side-effects between the groups
Measured: In the first hours after anaesthesia and surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study start1 Mar 2008
- Primary completion19 Jun 2009
- Study completion19 Jun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Struys, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00735748
- Sponsor's protocol ID
- 2007/526
- Status last verified
- Jan 2023
- First submitted
- 14 Aug 2008
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00735748
- Acronym / sponsor ID
- 2007/526
- Conditions
- Pain
- Keywords
- Patients who will undergo a general anesthesia for a procedure in short stay
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- 1 Mar 2008 (actual)
- Primary completion
- 19 Jun 2009 (actual)
- Study completion
- 19 Jun 2009 (actual)
- First posted
- 15 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Tramadol per os (Tradonal Odis® orodispersible tablets)Tramadol per os (Tradonal Odis® orodispersible tablets) |
| 2 | Active comparator | Drug: Tramadol IV (Tradonal® IV)Tramadol IV (Tradonal® IV) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I and II female or male patients undergoing wisdom teeth extraction
- Aged 18-70 years
- Scheduled for ambulatory surgery requiring postoperative pain medication
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tramadol per os (Tradonal Odis® orodispersible tablets)Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages | Drug | 1 |
| Tramadol IV (Tradonal® IV)Administration of tramadol IV given in 3 unit dosage of 35 mg | Drug | 2 |
Primary outcome
Difference in pain score between groups
Time frame: In the first hours after anaesthesia and surgery
1 secondary outcome
Difference in side-effects between the groups
Time frame: In the first hours after anaesthesia and surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Website of the University Hospital GhentLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel Struys, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tramadol per os (Tradonal Odis® orodispersible tablets) and Tramadol IV (Tradonal® IV) in people with Pain, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in pain score between groups (time frame: In the first hours after anaesthesia and surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.