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

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitair Ziekenhuis Brussel
• Treatments: Tramadol

Criteria

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