Status:
COMPLETED
Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
Lead Sponsor:
Jenny Boucher, PharmD
Conditions:
Pain
Anxiety
Eligibility:
All Genders
5-18 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the amount of anxiety and pain felt by children during procedures that require a needle stick after using a topical anesthetic or placebo cream.
Detailed Description
Pediatric patients frequently receive eutectic mixture of local anesthetics (EMLA) or other anesthetic medications prior to venipuncture. However, the time for the anesthetic to take affect is approxi...
Eligibility Criteria
Inclusion
- children ages 5-18 years of age
- treated as an inpatient or outpatient at Lehigh Valley Hospital within the past 24 hours
- venipuncture order, and that order is their initial venipuncture order (required within 30 mins)
Exclusion
- known allergy to EMLA, LMX4 or any of their ingredients
- known sensitivities to local anesthetics of the amide type, lidocaine or prilocaine
- G6PD deficiency
- methemoglobinemia or concomitant administration of methemoglobin-inducing agent
- brain injured or disoriented (Glasgow Coma Scale \<15)
- cognitively impaired (Mini Mental Status Exam \<28)
- active skin conditions at venipuncture site including frequent rashes, eczema or unexplained bruising
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00676364
Start Date
March 1 2003
End Date
February 1 2008
Last Update
September 25 2012
Active Locations (1)
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1
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103