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

August 24, 2012 updated by: Jenny Boucher, PharmD

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Lehigh Valley Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 4% lidocaine topical anesthetic cream
This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick.
Drug: 4% lidocaine topical anesthetic cream
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 Comparator: Placebo
This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.
Drug: Placebo cream
A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pain was measured immediately after venipuncture.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During venipuncture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jenny Boucher, PharmD

Investigators

  • Principal Investigator: Jenny Boucher, PharmD, Lehigh Valley Hospital
  • Principal Investigator: Scott Brenner, MD, Lehigh Valley Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 9, 2008

First Submitted That Met QC Criteria

May 9, 2008

First Posted (Estimate)

May 13, 2008

Study Record Updates

Last Update Posted (Estimate)

September 25, 2012

Last Update Submitted That Met QC Criteria

August 24, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-20030313

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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