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

Study Overview
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Brief Summary
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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
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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).

Official Title
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A Randomized, Placebo-Controlled Trial to Evaluate Pain and Anxiety During Venipuncture in Pediatric Patients With or Without Pre-treatment by a Topical Anesthetic

Conditions
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Pain, Anxiety

Intervention / Treatment
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* Drug: 4% lidocaine topical anesthetic cream
* Drug: Placebo cream


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4% lidocaine topical anesthetic cream<br>This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick. | Drug: 4% lidocaine topical anesthetic cream<br>* A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture<br>* Other names: 4% liposomal lidocaine (Brand name = LMX4);|
| Placebo Comparator: Placebo<br>This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick. | Drug: Placebo cream<br>* A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain From Venipuncture | Pain was measured immediately after venipuncture by the participant using the six-point FACES scale. FACES in not an acronym, but rather a description of a pain scale that uses pictures of faces in various states of pain. The FACES pain scale is a common scale used to measure pain with scores on a scale. The scale we used had six points from zero (0) to five (5) indicating different levels of pain. Lower scores indicate lower levels of pain, and higher scores indicate higher levels of pain. | Pain was measured immediately after venipuncture. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety of Venipuncture | Participant anxiety was measured by the study participant and the objective observer before (anticipatory), during (venipuncture) and after (recovery) venipuncture using a validated visual analog scale (VAS). The VAS is a validated scale that is used to detect small changes in many types of observations. The scale ranges from 0-100 scores on a scale, and here the higher scores indicate higher anxiety levels. Only the participant's mean venipuncture (during venipuncture) anxiety scores are presented in outcome measure results here. | During venipuncture | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pediatric patients, pain, anxiety, topical anesthetic, randomized control trial