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

Primary Purpose

Pain, Anxiety

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
4% lidocaine topical anesthetic cream
Placebo cream
Sponsored by
Jenny Boucher, PharmD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pediatric patients, pain, anxiety, topical anesthetic, randomized control trial

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Lehigh Valley Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

4% lidocaine topical anesthetic cream

Placebo

Arm Description

This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick.

This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 9, 2008
Last Updated
August 24, 2012
Sponsor
Jenny Boucher, PharmD
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1. Study Identification

Unique Protocol Identification Number
NCT00676364
Brief Title
Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
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 Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jenny Boucher, PharmD

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Anxiety
Keywords
pediatric patients, pain, anxiety, topical anesthetic, randomized control trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4% lidocaine topical anesthetic cream
Arm Type
Active Comparator
Arm Description
This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.
Intervention Type
Drug
Intervention Name(s)
4% lidocaine topical anesthetic cream
Other Intervention Name(s)
4% liposomal lidocaine (Brand name = LMX4)
Intervention Description
A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture
Intervention Type
Drug
Intervention Name(s)
Placebo cream
Intervention Description
A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture
Primary Outcome Measure Information:
Title
Pain From Venipuncture
Description
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.
Time Frame
Pain was measured immediately after venipuncture.
Secondary Outcome Measure Information:
Title
Anxiety of Venipuncture
Description
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.
Time Frame
During venipuncture

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenny Boucher, PharmD
Organizational Affiliation
Lehigh Valley Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott Brenner, MD
Organizational Affiliation
Lehigh Valley Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10353976
Citation
Koh JL, Fanurik D, Stoner PD, Schmitz ML, VonLanthen M. Efficacy of parental application of eutectic mixture of local anesthetics for intravenous insertion. Pediatrics. 1999 Jun;103(6):e79. doi: 10.1542/peds.103.6.e79.
Results Reference
background
PubMed Identifier
8867250
Citation
Lander J, Hodgins M, Nazarali S, McTavish J, Ouellette J, Friesen E. Determinants of success and failure of EMLA. Pain. 1996 Jan;64(1):89-97. doi: 10.1016/0304-3959(95)00100-X.
Results Reference
background
PubMed Identifier
12042548
Citation
Eichenfield LF, Funk A, Fallon-Friedlander S, Cunningham BB. A clinical study to evaluate the efficacy of ELA-Max (4% liposomal lidocaine) as compared with eutectic mixture of local anesthetics cream for pain reduction of venipuncture in children. Pediatrics. 2002 Jun;109(6):1093-9. doi: 10.1542/peds.109.6.1093.
Results Reference
background
PubMed Identifier
15520120
Citation
Zempsky WT, Cravero JP; American Academy of Pediatrics Committee on Pediatric Emergency Medicine and Section on Anesthesiology and Pain Medicine. Relief of pain and anxiety in pediatric patients in emergency medical systems. Pediatrics. 2004 Nov;114(5):1348-56. doi: 10.1542/peds.2004-1752.
Results Reference
background
PubMed Identifier
1517650
Citation
Lander J, Fowler-Kerry S, Oberle S. Children's venipuncture pain: influence of technical factors. J Pain Symptom Manage. 1992 Aug;7(6):343-9. doi: 10.1016/0885-3924(92)90087-x.
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PubMed Identifier
19528768
Citation
Barnett P. Alternatives to sedation for painful procedures. Pediatr Emerg Care. 2009 Jun;25(6):415-9; quiz 420-2. doi: 10.1097/PEC.0b013e3181a93ff3.
Results Reference
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PubMed Identifier
15601345
Citation
Koh JL, Harrison D, Myers R, Dembinski R, Turner H, McGraw T. A randomized, double-blind comparison study of EMLA and ELA-Max for topical anesthesia in children undergoing intravenous insertion. Paediatr Anaesth. 2004 Dec;14(12):977-82. doi: 10.1111/j.1460-9592.2004.01381.x.
Results Reference
background
PubMed Identifier
19690240
Citation
Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X. The perioperative validity of the visual analog anxiety scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg. 2009 Sep;109(3):737-44. doi: 10.1213/ane.0b013e3181af00e4.
Results Reference
background
PubMed Identifier
20003121
Citation
Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9.
Results Reference
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PubMed Identifier
2678015
Citation
Gift AG. Visual analogue scales: measurement of subjective phenomena. Nurs Res. 1989 Sep-Oct;38(5):286-8. No abstract available.
Results Reference
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PubMed Identifier
20921070
Citation
Tomlinson D, von Baeyer CL, Stinson JN, Sung L. A systematic review of faces scales for the self-report of pain intensity in children. Pediatrics. 2010 Nov;126(5):e1168-98. doi: 10.1542/peds.2010-1609. Epub 2010 Oct 4.
Results Reference
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PubMed Identifier
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Citation
Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.
Results Reference
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PubMed Identifier
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Citation
Kaweski S; Plastic Surgery Educational Foundation Technology Assessment Committee. Topical anesthetic creams. Plast Reconstr Surg. 2008 Jun;121(6):2161-2165. doi: 10.1097/PRS.0b013e318170a7a4.
Results Reference
background
Links:
URL
http://www.jointcommission.org/assets/1/18/Pain_Management.pdf
Description
The Joint Commission's position on pain management.

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

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