NCT00893412

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Universitair Ziekenhuis Brussel · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Infertility
• Pain

Interventions

Type	Name	Description
DRUG	Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)	1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)
PROCEDURE	Hysterosalpingography (HSG)	One HSG using a metal canula or balloon catheter, 30 minutes after tablet
DRUG	Placebo

Timeline

• Start date: 2008-11-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2009-05-06
• Last updated: 2009-05-06

Locations

1 site across 1 country: Belgium