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A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

Information source: EUSA Pharma (US), Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy; Anesthesia

Intervention: Rapydan (Drug); tetracaine gel (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: EUSA Pharma (US), Inc.

Official(s) and/or principal investigator(s):
Rahul Dimber, MD, Principal Investigator, Affiliation: EUSA Pharma

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome: 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)

Secondary outcome: To demonstrate comparable tolerability between Rapydan medicated plaster and tetracaine gel

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 This study has been withdrawn and no additional data is available.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

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

Locations and Contacts

Merthyr Tydfill Industrial Estate, Merthyr, Tydfill CF48 4DR, United Kingdom
Additional Information

Starting date: April 2008
Last updated: April 24, 2012

Page last updated: August 23, 2015

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