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

Phase 1

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

Registration Number: EUCTR2007-003420-38-SE

Lead Sponsor: meå University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br><br>;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).

Secondary Outcome Measures