Trial | NCT00670696  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
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 This study has been withdrawn and no additional data is available.
Study Started
Apr 30
2008
Primary Completion
Dec 31
2008
Anticipated
Last Update
Apr 25
2012
Estimate

Drug Rapydan

Topical anaesthetic plaster

Drug tetracaine gel

Topical tetracaine gel

A Experimental

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

B Active Comparator

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

Criteria 

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
No Results Posted