A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

Jazz Pharmaceuticals

Status and phase: Withdrawn; Phase 4

Conditions: Healthy; Anesthesia

Treatments: Drug: Rapydan; Drug: tetracaine gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00670696

RD 305/24674

Details and patient eligibility

About

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.

Full description

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 This study has been withdrawn and no additional data is available.

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups

A

Experimental group

Description:

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

Treatment:

Drug: Rapydan

B

Active Comparator group

Description:

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

Treatment:

Drug: tetracaine gel