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Influence of Rapydan on Clinical Chemistry and Hematology Measurements

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00765934
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : May 18, 2010
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Rapydan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Does Rapydan Influence Routine Clinical Chemistry and Hematology Measurements?
Study Start Date : November 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Routine Clinical Chemistry measurements differences [ Time Frame: 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00765934

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Groningen, Netherlands
Sponsors and Collaborators
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Study Director: Rob Oude Elferink, MSc LabNoord
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Responsible Party: R.F.M. Oude Elferink, LabNoord Identifier: NCT00765934    
Other Study ID Numbers: RapydanClinicalChemistry
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: May 18, 2010
Last Verified: May 2010
Keywords provided by LabNoord:
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action