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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

Status
Withdrawn
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00670696
Enrollment
0
Registered
2008-05-02
Start date
2008-04-30
Completion date
Unknown
Last updated
2012-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Healthy

Keywords

Topical anesthesia, Rapydan, Topical anaesthesia for venous cannulation

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 This study has been withdrawn and no additional data is available.

Interventions

DRUGRapydan

Topical anaesthetic plaster

DRUGtetracaine gel

Topical tetracaine gel

Sponsors

Jazz Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To demonstrate comparable tolerability between Rapydan medicated plaster and tetracaine gelUp to 14 days post exposure

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026