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Completed

NCT Number: NCT00676364

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

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.

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Key information

Conditions

Pain Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lehigh Valley Hospital

Allentown, Pennsylvania, 18103, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4% lidocaine topical anesthetic cream

Drug

A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture

Other names: 4% liposomal lidocaine (Brand name = LMX4)

placebo cream

Drug

A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture

Primary outcomes

  1. Pain From Venipuncture

    Time frame: Pain was measured immediately after 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.

Secondary outcomes

  1. Anxiety of Venipuncture

    Time frame: During 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.

Sponsors and collaborators

Lead sponsor

Jenny Boucher, PharmD

Other

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
May 13, 2008
Registry last updated
Sep 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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