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Completed

NCT Number: NCT00893412

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

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.

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Key information

Conditions

Infertility Agnosia Genital Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

UZ Brussel

Brussels, 1090, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)

Drug

1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)

Other names: Tradonal odis®

Hysterosalpingography (HSG)

Procedure

One HSG using a metal canula or balloon catheter, 30 minutes after tablet

Other names: HSG

Placebo

Drug

Primary outcomes

  1. VAS at the six different assessment points

    Time frame: 24 hours

Secondary outcomes

  1. Adverse effects and complications

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Fast-Release Orodispersible Tramadol Tablet (Tradonal Odis®) as Analgesia for Hysterosalpingography : a Randomized, Controlled, Double Blinded Study

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 6, 2009
Registry last updated
May 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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