Influence of Rapydan on Clinical Chemistry and Hematology Measurements - Full Text View

Purpose

There is an increasing awareness of the importance of treating procedure-related pain. Patients undergoing vascular access procedures are often afraid of needles and the discomfort associated with injections. This type of pain and/or fear can be stressful to patients. [1] For prevention of the pain associated with these procedures, the hospital is using Rapydan plasters. Rapydan consists out of two local anesthetics: lidocaine and tetracaïne. Rapydan produces topical anesthesia after an application time of 30 minutes and is used in the Martini Hospital for pain relieve by venipuncture and IV cannulation. The venous blood draining the anaesthetized skin contains a higher blood concentration of the local anesthetics than does venous blood in other parts of the body [2] Although the concentrations of the local anesthetics are low in patients with normal skin, the question is whether the presence of the local anesthetics which Rapydan contains might influence routine measurements in clinical chemistry and hematology.

Condition	Intervention
Healthy	Drug: Rapydan

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Does Rapydan Influence Routine Clinical Chemistry and Hematology Measurements?

Resource links provided by NLM:

Drug Information available for: Lidocaine hydrochloride Tetracaine Tetracaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by LabNoord:

Primary Outcome Measures:

Routine Clinical Chemistry measurements differences [ Time Frame: 1 ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	November 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rapydan Internal control. Blood from both arms will be drawn. Only one arm of the subject is treated with Rapydan.	Drug: Rapydan lidocaine / tetracaine 70/70 mg patch Other Name: Lidocaine Tetracaine Patch

Eligibility

Ages Eligible for Study:	20 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Volunteers 20-60 years who are decision making competent

Exclusion Criteria:

Patients with local anesthetic allergy Patients using antiarrhythmic drugs Patients using other local anesthetics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765934

Locations

Netherlands
LabNoord
Groningen, Netherlands

Sponsors and Collaborators

LabNoord

Investigators

Study Director:

Rob Oude Elferink, MSc

LabNoord

More Information

Publications:

Curry SE, Finkel JC. Use of the Synera patch for local anesthesia before vascular access procedures: a randomized, double-blind, placebo-controlled study. Pain Med. 2007 Sep;8(6):497-502.

Amdisen A, Glud V. No influence from topical application of EMLA cream before blood sampling on routine clinical chemistry and haematology measurements. Eur J Clin Pharmacol. 1991;41(6):619-20.

Responsible Party:	R.F.M. Oude Elferink, LabNoord
ClinicalTrials.gov Identifier:	NCT00765934 History of Changes
Other Study ID Numbers:	RapydanClinicalChemistry
Study First Received:	October 2, 2008
Last Updated:	May 17, 2010
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by LabNoord:

Healthy

Additional relevant MeSH terms:

Tetracaine
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions

Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013