Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography
NCT ID: NCT00893412
Last Updated: 2009-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
128 participants
INTERVENTIONAL
2008-11-30
2009-04-30
Brief Summary
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Tramadol acts through a weak affinity for μ receptors and secondly by inhibiting noradrenaline and serotonin neuronal reuptake. It has been used since the 1970s by over 50 million people for the treatment of acute and chronic pain. The orodispersible Tramadol tablet is a new galenic form and is available on the Belgian market for the last three years. Pregastric absorption leads to a quicker onset of action.
So far, evidence shows that pain during and immediately after the Hysterosalpingography (HSG) procedure is only significantly reduced by IV opioid analgesia. This study evaluates the analgetic potential of an orodispersible opioid tablet. This tablet disintegrates rapidly (in around 20-30 seconds) and may be taken without water. Its abuse potential is very low and its respiratory depressant effect is negligible.
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Detailed Description
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Patients that need a HSG as part of their diagnostic work-up and are eligible for randomization are counseled about possible participation. After signing the informed consent patients will be randomized in one of the following four groups:
Group 1: Fast-release Orodispersible Tramadol Tablet + metal cannula Group 2: Placebo + metal cannula Group 3: Fast-release Orodispersible Tramadol Tablet + balloon catheter Group 4: Placebo + balloon catheter
Tablets are administered 30 min before the procedure
Primary Endpoint:
* VAS at the six different assessment points
Secondary Endpoint
* adverse effects and complications such as: nausea, vomiting, constipation, drowsiness, respiratory depression, hypotension, allergic reaction and infection
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Tramadol + Metal cannula
Fast-release Orodispersible Tramadol Tablet + Metal cannula
Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
Hysterosalpingography (HSG)
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Placebo + Metal cannula
Placebo + Metal cannula
Hysterosalpingography (HSG)
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Placebo
Tramadol + Balloon
Fast-release Orodispersible Tramadol Tablet + balloon catheter
Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
Hysterosalpingography (HSG)
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Placebo + Balloon
Placebo + balloon catheter
Hysterosalpingography (HSG)
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Placebo
Interventions
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Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
Hysterosalpingography (HSG)
One HSG using a metal canula or balloon catheter, 30 minutes after tablet
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Concomitant use of MAO inhibitors or use less than 2 weeks prior to procedure
* Use of any other CNS-acting drug
* Contra-indication to radio-contrast medium (allergy)
* Patient already taking analgetics
* History of cervical stenosis
* Presence of pelvic inflammatory disease or any other condition causing pelvic pain
* Clinical and/or laboratory evidence of any major disease
* Pregnant or lactating
18 Years
45 Years
FEMALE
No
Sponsors
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Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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UZ Brussel
Principal Investigators
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Paul Devroey, MD, PhD
Role: STUDY_DIRECTOR
Universitair Ziekenhuis Brussel
Locations
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UZ Brussel
Brussels, , Belgium
Countries
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Other Identifiers
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2008/191
Identifier Type: -
Identifier Source: org_study_id
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