A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

Study Overview
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Brief Summary
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Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively.

Detailed Description
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Tetracaine gel 4% is a topical anaesthetic gel commonly used in the UK that contains 40 mg of tetracaine base per gram. Adequate anaesthesia can usually be achieved following a 30 minute application time for venopuncture and a 45 minute application time for venous cannulation. The hypothesis is that Rapydan medicated plaster is more effective than tetracaine gel in preventing venous cannulation related pain when applied for the recommended treatment durations of 30 minutes and 45 minutes respectively. This study has been withdrawn and no additional data is available.

Official Title
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A Randomised, Controlled, Single-blinded, Cross Over Comparison Study to Compare the Efficacy of the Rapydan Medicated Plaster Versus Tetracaine Gel

Conditions
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Healthy, Anesthesia

Intervention / Treatment
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* Drug: Rapydan
* Drug: tetracaine gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects of any race, 18 yrs or older No clinically significant findings on physical exam Signed informed consent Exclusion Criteria: Damaged, denuded or broken skin at the designated site for application of the medicated plaster or gel. Know allergies to lidocaine, tetracaine or other local anaesthetics Concomitant use of prescription strength analgesics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Rapydan medicated plaster administered 30 minutes prior to cannulation on Visit 1 and tetracaine gel administered 45 minutes prior to cannulation on Visit 2. | Drug: Rapydan<br>* Topical anaesthetic plaster<br>|
| Active Comparator: B<br>Tetracaine gel administered 45 prior to cannulation on Visit 1 and then Rapydan administered 30 minutes prior to cannulation on Visit 1 | Drug: tetracaine gel<br>* Topical tetracaine gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate superiority for Rapydan medicated plaster applied 30 minutes over tetracaine gel applied for 45 minutes in terms of reducing pain associated with venous cannulation as assessed by the subject on a 100 mm visual analog scale (VAS) |  | VAS post venous cannulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate comparable tolerability between Rapydan medicated plaster and tetracaine gel |  | Up to 14 days post exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Topical anesthesia, Rapydan, Topical anaesthesia for venous cannulation