Pain Clinical Trial
Official title:
Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study
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.
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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