The effect of Rapydan lidocain/tetracain patch on pain-response and reproducibilty in Tuberculin test - Tuberculin and topical anesthesia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003420-38-SE

Enrollment

Registered

2007-10-24

Start date

2007-12-28

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain response to intradermal injection of tuberculin. MedDRA version: 9.1 Level: LLT Classification code 10064882 Term: Procedural pain MedDRA version: 9.1 Level: LLT Classification code 10044726 Term: Tuberculin test

Interventions

Trade Name: Rapydan Product Name: Rapydan Pharmaceutical Form: Medicated plaster Pharmaceutical form of the placebo: Medicated plaster Route of administration of the placebo: Transdermal use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Phase 1: 10 Adult volunteers recruited among medical staff, known to be vaccinated with BCG. Phase 2: Sixty children, 6-16 years of age, submitted to the paediatric outpatient clinic and scheduled for tuberculin test. The children will participate consecutively after informed consent is given by parent and child. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Exclusion criteria: Any known hypersensitivity to the local anaesthesia in the patch-substances or ongoing treatment with other analgesics. The Mantoux-tests in children are routinely performed in the pediatric out-patient clinic. The study population will be representative since all children who are scheduled for the mantoux-test during the study period will be invited to participate.

Design outcomes

Primary

Measure	Time frame
Main Objective: The aim of the study is to determine whether Rapydan decreases the pain associated with the intradermal injection of tuberculin in adults and in children ;Secondary Objective: and if the application of Rapydan has an influence on the result of the tuberculin-test.;Primary end point(s): The primary outcome data in phase 1 will be the size of the induration area and secondary the injection pain, measured by VAS (0-100 mm). In phase 2 pain during the intracutaneous injection, measured by Faces-Pain-Scale- revised version. (0-10).	—

Measure

Time frame

Main Objective: The aim of the study is to determine whether Rapydan decreases the pain associated with the intradermal injection of tuberculin in adults and in children ;Secondary Objective: and if the application of Rapydan has an influence on the result of the tuberculin-test.;Primary end point(s): The primary outcome data in phase 1 will be the size of the induration area and secondary the injection pain, measured by VAS (0-100 mm). In phase 2 pain during the intracutaneous injection, measured by Faces-Pain-Scale- revised version. (0-10).

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026