Influence of Rapydan on Clinical Chemistry and Hematology Measurements

Healthy Clinical Trial

Official title:

Does Rapydan Influence Routine Clinical Chemistry and Hematology Measurements?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00765934
• Other study ID #: RapydanClinicalChemistry
• Status: Completed
• Phase: N/A
• First received: October 2, 2008
• Last updated: May 17, 2010
• Start date: November 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2010
• Source: LabNoord
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Rapydan
lidocaine / tetracaine 70/70 mg patch

Locations

Country	Name	City	State
Netherlands	LabNoord	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
LabNoord

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Routine Clinical Chemistry measurements differences		1	No