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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Infertility
• Intervention / Treatment: Drug: Placebo; Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); Procedure: Hysterosalpingography (HSG)

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

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tramadol + Metal cannula; Fast-release Orodispersible Tramadol Tablet + Metal cannula	Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); 1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); Other Names: Tradonal odis®; Procedure: Hysterosalpingography (HSG); One HSG using a metal canula or balloon catheter, 30 minutes after tablet; Other Names: HSG
Placebo Comparator: Placebo + Metal cannula	Drug: Placebo; Procedure: Hysterosalpingography (HSG); One HSG using a metal canula or balloon catheter, 30 minutes after tablet; Other Names: HSG
Active Comparator: Tramadol + Balloon; Fast-release Orodispersible Tramadol Tablet + balloon catheter	Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); 1 tablet of 50 mg Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); Other Names: Tradonal odis®; Procedure: Hysterosalpingography (HSG); One HSG using a metal canula or balloon catheter, 30 minutes after tablet; Other Names: HSG
Placebo Comparator: Placebo + Balloon; Placebo + balloon catheter	Drug: Placebo; Procedure: Hysterosalpingography (HSG); One HSG using a metal canula or balloon catheter, 30 minutes after tablet; Other Names: HSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VAS at the six different assessment points	24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse effects and complications	24 hours

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Study Director: Paul Devroey, MD, PhD, Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): April 1, 2009
• Study Completion (Actual): April 1, 2009

Study Registration Dates

• First Submitted: May 4, 2009
• First Submitted That Met QC Criteria: May 4, 2009
• First Posted (Estimate): May 6, 2009

Study Record Updates

• Last Update Posted (Estimate): May 6, 2009
• Last Update Submitted That Met QC Criteria: May 4, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: analgesia; balloon catheter; tramadol; HSG; metal cannula
• Additional Relevant MeSH Terms: Infertility; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Tramadol
• Other Study ID Numbers: 2008/191