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

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ClinicalTrials.gov Identifier: NCT00676364
Recruitment Status : Completed
First Posted : May 13, 2008
Results First Posted : September 25, 2012
Last Update Posted : September 25, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Pain Anxiety Drug: 4% lidocaine topical anesthetic cream Drug: Placebo cream Phase 4

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : March 2003
Primary Completion Date : February 2008
Study Completion Date : February 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia Anxiety
U.S. FDA Resources

Arms and Interventions

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 Name: 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

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Eligibility Criteria

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676364

United States, Pennsylvania
Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Sponsors and Collaborators
Jenny Boucher, PharmD
Principal Investigator: Jenny Boucher, PharmD Lehigh Valley Hospital
Principal Investigator: Scott Brenner, MD Lehigh Valley Hospital
More Information

Additional Information:

Responsible Party: Jenny Boucher, PharmD, Investigator, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00676364     History of Changes
Other Study ID Numbers: 1-20030313
First Posted: May 13, 2008    Key Record Dates
Results First Posted: September 25, 2012
Last Update Posted: September 25, 2012
Last Verified: August 2012

Keywords provided by Jenny Boucher, PharmD, Lehigh Valley Hospital:
pediatric patients
topical anesthetic
randomized control trial

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action