A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

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.

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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 This study has been withdrawn and no additional data is available.

Conditions

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Healthy Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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A

Rapydan medicated plaster administered 30 minutes prior to cannulation on Visit 1 and tetracaine gel administered 45 minutes prior to cannulation on Visit 2.

Group Type EXPERIMENTAL

Rapydan

Intervention Type DRUG

Topical anaesthetic plaster

B

Tetracaine gel administered 45 prior to cannulation on Visit 1 and then Rapydan administered 30 minutes prior to cannulation on Visit 1

Group Type ACTIVE_COMPARATOR

tetracaine gel

Intervention Type DRUG

Topical tetracaine gel

Interventions

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Rapydan

Topical anaesthetic plaster

Intervention Type DRUG

tetracaine gel

Topical tetracaine gel

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes