Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture

Completed · Phase 4 · Has a placebo group

Conditions studied: Pain, Anxiety

In brief

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.

Key facts

Study ID

NCT00676364

Run by

Jenny Boucher, PharmD

People needed

114

Starts

2003-03-01

Expected to finish

2008-02-01

Last updated by the study team

2012-09-25

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Lehigh Valley Hospital — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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