Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography
Launched by UNIVERSITAIR ZIEKENHUIS BRUSSEL · May 4, 2009
Trial Information
Current as of May 06, 2025
Completed
Keywords
ClinConnect Summary
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 d...
Gender
FEMALE
Eligibility 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
About Universitair Ziekenhuis Brussel
Universitair Ziekenhuis Brussel (UZ Brussel) is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent institution affiliated with the Vrije Universiteit Brussel, UZ Brussel integrates cutting-edge medical research with high-quality patient care. The hospital's multidisciplinary teams are dedicated to exploring novel therapeutic approaches and contributing to the development of evidence-based treatments, ensuring the highest standards of safety and efficacy in clinical research. With a strong focus on collaboration and knowledge dissemination, UZ Brussel plays a pivotal role in shaping the future of medicine and improving patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Brussels, , Belgium
Patients applied
Trial Officials
Paul Devroey, MD, PhD
Study Director
Universitair Ziekenhuis Brussel
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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