Clinical trial NCT00676364: Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
Official title: A Randomized, Placebo-Controlled Trial to Evaluate Pain and Anxiety During Venipuncture in Pediatric Patients With or Without Pre-treatment by a Topical Anesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Anxiety
Keywords: pediatric patients
pain
anxiety
topical anesthetic
randomized control trial
Lead sponsor: Lehigh Valley Hospital
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 114
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 approximately 60 minutes. Another anesthetic medication besides EMLA is lidocaine 4% topical anesthetic cream (LMX4), which has a shorter acting time (30 minutes) compared to the EMLA, making it a more desirable medication when urgent labs are required. This medication is being evaluated to assess the anxiety and pain associated with venipuncture in 15 minutes versus the approved 30 minutes of pediatric patients treated as an inpatient or outpatient in the local Emergency Department, compared to standard care (no prior treatment).

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Pain From Venipuncture
timeFrame: Pain was measured immediately after venipuncture.
Secondary outcomes:
measure: Anxiety of Venipuncture
timeFrame: During venipuncture
Other outcomes:
Locations:
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
Study officials:
affiliation: Lehigh Valley Hospital
name: Jenny Boucher, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lehigh Valley Hospital
name: Scott Brenner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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