Influence of Rapydan on Clinical Chemistry and Hematology Measurements
Does Rapydan Influence Routine Clinical Chemistry and Hematology Measurements?
1 other identifier
interventional
25
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable healthy
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2008
CompletedFirst Posted
Study publicly available on registry
October 3, 2008
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedMay 18, 2010
May 1, 2010
6 months
October 2, 2008
May 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Routine Clinical Chemistry measurements differences
1
Study Arms (1)
Rapydan
OTHERInternal control. Blood from both arms will be drawn. Only one arm of the subject is treated with Rapydan.
Interventions
Eligibility Criteria
You may qualify if:
- Volunteers 20-60 years who are decision making competent
You may not qualify if:
- Patients with local anesthetic allergy Patients using antiarrhythmic drugs Patients using other local anesthetics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LabNoordlead
Study Sites (1)
LabNoord
Groningen, Provincie Groningen, Netherlands
Related Publications (2)
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.
PMID: 17716323BACKGROUNDAmdisen 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.
PMID: 1815978BACKGROUND
Study Officials
- STUDY DIRECTOR
Rob Oude Elferink, MSc
LabNoord
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 2, 2008
First Posted
October 3, 2008
Study Start
November 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
May 18, 2010
Record last verified: 2010-05