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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jenny Boucher, PharmD, Lehigh Valley Hospital
ClinicalTrials.gov Identifier:
NCT00676364
First received: May 9, 2008
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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 Intervention Phase
Pain
Anxiety
Drug: 4% lidocaine topical anesthetic cream
Drug: Placebo cream
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Lehigh Valley Hospital:

Primary Outcome Measures:
  • Pain From Venipuncture [ Time Frame: Pain was measured immediately after venipuncture. ] [ Designated as safety issue: No ]
    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:
  • Anxiety of Venipuncture [ Time Frame: During venipuncture ] [ Designated as safety issue: No ]
    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.


Enrollment: 114
Study Start Date: March 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: Placebo cream

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).

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00676364

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

Additional Information:
Publications:

Responsible Party: Jenny Boucher, PharmD, Investigator, Lehigh Valley Hospital
ClinicalTrials.gov Identifier: NCT00676364     History of Changes
Other Study ID Numbers: 1-20030313
Study First Received: May 9, 2008
Results First Received: May 1, 2012
Last Updated: August 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Lehigh Valley Hospital:
pediatric patients
pain
anxiety
topical anesthetic
randomized control trial

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

ClinicalTrials.gov processed this record on November 27, 2014