Clinical trial NCT00893412: Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography
Official title: Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Pain
Keywords: HSG
analgesia
tramadol
metal cannula
balloon catheter
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 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

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

Primary outcomes:
measure: VAS at the six different assessment points
timeFrame: 24 hours
Secondary outcomes:
measure: Adverse effects and complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Paul Devroey, MD, PhD
role: STUDY_DIRECTOR
References: