Influence of Rapydan on Clinical Chemistry and Hematology Measurements

This study has been completed.
Sponsor:
Information provided by:
LabNoord
ClinicalTrials.gov Identifier:
NCT00765934
First received: October 2, 2008
Last updated: May 17, 2010
Last verified: May 2010
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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

ClinicalTrials.gov processed this record on September 22, 2014