Influence of Rapydan on Clinical Chemistry and Hematology Measurements

NCT ID: NCT00765934

Last Updated: 2010-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-05-31

Brief 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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Rapydan

Internal control. Blood from both arms will be drawn. Only one arm of the subject is treated with Rapydan.

Group Type: OTHER

Rapydan

Intervention Type: DRUG

lidocaine / tetracaine 70/70 mg patch

Interventions

Rapydan

lidocaine / tetracaine 70/70 mg patch

Intervention Type: DRUG

Other Intervention Names

Lidocaine Tetracaine Patch

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LabNoord

OTHER

Sponsor Role: lead

Responsible Party

LabNoord

Principal Investigators

Rob Oude Elferink, MSc

Role: STUDY_DIRECTOR

LabNoord

Locations

LabNoord

Groningen, Provincie Groningen, Netherlands

Countries

Netherlands

References

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. doi: 10.1111/j.1526-4637.2006.00204.x.

Reference Type: BACKGROUND

PMID: 17716323 (View on PubMed)

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. doi: 10.1007/BF00314997.

Reference Type: BACKGROUND

PMID: 1815978 (View on PubMed)

Other Identifiers

RapydanClinicalChemistry

Identifier Type: -

Identifier Source: org_study_id