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

Universitair Ziekenhuis Brussel

Status and phase: Completed; Phase 4

Conditions: Infertility; Pain

Treatments: Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®); Procedure: Hysterosalpingography (HSG); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00893412

2008/191

Details and patient eligibility

About

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.

Full 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

Enrollment: 128 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 4 patient groups, including a placebo group

Tramadol + Metal cannula

Active Comparator group

Description:

Fast-release Orodispersible Tramadol Tablet + Metal cannula

Treatment:

Procedure: Hysterosalpingography (HSG)

Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)

Placebo + Metal cannula

Placebo Comparator group

Description:

Placebo + Metal cannula

Treatment:

Drug: Placebo

Procedure: Hysterosalpingography (HSG)

Tramadol + Balloon

Active Comparator group

Description:

Fast-release Orodispersible Tramadol Tablet + balloon catheter

Treatment:

Procedure: Hysterosalpingography (HSG)

Drug: Fast-release Orodispersible Tramadol Tablet (Tradonal odis®)

Placebo + Balloon

Placebo Comparator group

Description:

Placebo + balloon catheter

Treatment:

Drug: Placebo

Procedure: Hysterosalpingography (HSG)