Status:

COMPLETED

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

Lead Sponsor:

Universitair Ziekenhuis Brussel

Conditions:

Infertility

Pain

Eligibility:

FEMALE

18-45 years

Phase:

PHASE4

Brief 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 serot...

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 ...

Eligibility Criteria

Inclusion

  • \> 18 and \< 45 years
  • Written informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2009

Estimated Enrollment :

128 Patients enrolled

Trial Details

Trial ID

NCT00893412

Start Date

November 1 2008

End Date

April 1 2009

Last Update

May 6 2009

Active Locations (1)

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UZ Brussel

Brussels, Belgium, 1090