Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography

Study Overview
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Brief Summary
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This study evaluates the analgetic effects of the fast-release orodispersible tramadol tablet. 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.

Detailed Description
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Four arm prospective randomized double blinded trial 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

Official Title
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Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study

Conditions
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Infertility, Pain

Intervention / Treatment
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* Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
* Procedure: Hysterosalpingography (HSG)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: > 18 and < 45 years Written informed consent Exclusion Criteria: Contra-indication to tramadol, morphine or to other opioids 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tramadol + Metal cannula<br>Fast-release Orodispersible Tramadol Tablet + Metal cannula | Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)<br>* 1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)<br>* Other names: Tradonal odis®;Procedure: Hysterosalpingography (HSG)<br>* One HSG using a metal canula or balloon catheter, 30 minutes after tablet<br>* Other names: HSG;|
| Placebo Comparator: Placebo + Metal cannula<br>Placebo + Metal cannula | Procedure: Hysterosalpingography (HSG)<br>* One HSG using a metal canula or balloon catheter, 30 minutes after tablet<br>* Other names: HSG;Drug: Placebo<br> <br> |
| Active Comparator: Tramadol + Balloon<br>Fast-release Orodispersible Tramadol Tablet + balloon catheter | Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)<br>* 1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)<br>* Other names: Tradonal odis®;Procedure: Hysterosalpingography (HSG)<br>* One HSG using a metal canula or balloon catheter, 30 minutes after tablet<br>* Other names: HSG;|
| Placebo Comparator: Placebo + Balloon<br>Placebo + balloon catheter | Procedure: Hysterosalpingography (HSG)<br>* One HSG using a metal canula or balloon catheter, 30 minutes after tablet<br>* Other names: HSG;Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS at the six different assessment points |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects and complications |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSG, analgesia, tramadol, metal cannula, balloon catheter