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

Jenny Boucher, PharmD

Status and phase: Completed; Phase 4

Conditions: Anxiety; Pain

Treatments: Drug: 4% lidocaine topical anesthetic cream; Drug: Placebo cream

Study type: Interventional

Funder types: Other

Identifiers

NCT00676364

1-20030313

Details and patient eligibility

About

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.

Full 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).

Enrollment: 114 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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114 participants in 2 patient groups, including a placebo group

4% lidocaine topical anesthetic cream

Active Comparator group

Description:

This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick.

Treatment:

Drug: 4% lidocaine topical anesthetic cream

Placebo

Placebo Comparator group

Description:

This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.

Treatment:

Drug: Placebo cream