A Study to Compare the Efficacy of Rapydan Versus Tetracaine Gel

Phase 4

Withdrawn

• Conditions: Healthy; Anesthesia
• Interventions: Drug: Rapydan; Drug: tetracaine gel

• Registration Number: NCT00670696
• Lead Sponsor: Jazz Pharmaceuticals

Brief 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.

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 This study has been withdrawn and no additional data is available.

Study Timeline

• Study Start: 2008-04
• Study First Submitted: 2008-04-29
• Study First Submitted QC: 2008-05-01
• Study First Posted: 2008-05-02
• Primary Completion: 2008-12
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-24
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Rapydan	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	tetracaine gel	Tetracaine gel administered 45 prior to cannulation on Visit 1 and then Rapydan administered 30 minutes prior to cannulation on Visit 1

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
To demonstrate comparable tolerability between Rapydan medicated plaster and tetracaine gel	Up to 14 days post exposure

Trial Locations

Locations (1)

Merthyr Tydfill Industrial Estate; 🇬🇧 Merthyr, Tydfill, United Kingdom