Rapydan for topical anesthesia

Prospective, Randomized Clinical Pilot Study: Use of Lidocaine/Tetracaine Patch (Rapydan®) for Topical Anesthesia before Aterial Access - Rapydan

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024185-22-AT

Enrollment

100

Registered

2011-04-26

Start date

2011-06-08

Completion date

Unknown

Last updated

2016-12-12

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

Conditions

Rapydan, ein neuartiges Schmerzpflaster, enthält zwei Lokalanästhetika (Lidocain und Tetracain) in höherer Dosierung (jeweils 70mg) als herkömmliche topische Schmerzpflaster. Die Studie soll zeigen, ob mit dieser nichtinvasiven Methode ausreichende Schmerzfreiheit bei einer arteriellen Punktion erzielt werden kann.

Interventions

Trade Name: Rapydan Pharmaceutical Form: Medicated plaster CAS Number: 94-24-6 Other descriptive name: Tetracain Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 70-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Written informed consent - Planned used of arterial access before induction of general anesthesia - Elective cardiac surgery Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Inability to give informed consent - No use of pain medication 24 hours before administration of Rapydan® and Xylocaine - Injured or broken skin at the designated patch site - Unessential use of arterial access before general anesthesia - Known allergy to local anesthetics - Drug abuse, alcoholism or psychiatric disorders - High urgent operation - Childbearing potential - Pathologiacl Ellen Test

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluierung der Schmerzenintensität anhand des VAS;Secondary Objective: - ;Primary end point(s): The primary efficacy endpoint for this study is the pain intensity during the procedure as determined by a 100 mm VAS. The VAS ranges from 0 to 100. 0 score indicates no pain and 100 points indicates the worst possible pain. If a patient in the Rapydan®-group received a rescue medication (subcutaneous xylocaine injection); the patient is asked to consider the amount of pain associated with the arterial access procedure prior to the xylocaine injection. ;Timepoint(s) of evaluation of this end point: pain intensity during the procedure	—

Measure

Time frame

Main Objective: Evaluierung der Schmerzenintensität anhand des VAS;Secondary Objective: - ;Primary end point(s): The primary efficacy endpoint for this study is the pain intensity during the procedure as determined by a 100 mm VAS. The VAS ranges from 0 to 100. 0 score indicates no pain and 100 points indicates the worst possible pain. If a patient in the Rapydan®-group received a rescue medication (subcutaneous xylocaine injection); the patient is asked to consider the amount of pain associated with the arterial access procedure prior to the xylocaine injection. ;Timepoint(s) of evaluation of this end point: pain intensity during the procedure

—

Secondary

Measure	Time frame
Secondary end point(s): n.a.;Timepoint(s) of evaluation of this end point: n.a.	—

Countries

Austria

Contacts

Public ContactProf. Hutschala

Med. Univ. Wien, Klinik für Anästhesie, Allgemeine Intensivmedizin und Schmerztherapie

doris.hutschala@meduniwien.ac.at00431404004018

Outcome results

None listed

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