Pain Clinical Trial
Official title:
Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study
Verified date | May 2009 |
Source | Universitair Ziekenhuis Brussel |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 128 |
Est. completion date | April 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Brussel | Brussels |
Lead Sponsor | Collaborator |
---|---|
Universitair Ziekenhuis Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | VAS at the six different assessment points | 24 hours | No | |
Secondary | Adverse effects and complications | 24 hours | Yes |
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