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

NCT ID: NCT00676364

Last Updated: 2012-09-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Study Completion Date

2008-02-29

Brief Summary

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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

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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).

Conditions

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Pain Anxiety

Keywords

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pediatric patients pain anxiety topical anesthetic randomized control trial

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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4% lidocaine topical anesthetic cream

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

Group Type ACTIVE_COMPARATOR

4% lidocaine topical anesthetic cream

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo cream

Intervention Type DRUG

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

Interventions

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4% lidocaine topical anesthetic cream

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

Intervention Type DRUG

Placebo cream

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

Intervention Type DRUG

Other Intervention Names

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4% liposomal lidocaine (Brand name = LMX4)

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jenny Boucher, PharmD

OTHER

Sponsor Role lead

Responsible Party

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Jenny Boucher, PharmD

Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jenny Boucher, PharmD

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Hospital

Scott Brenner, MD

Role: PRINCIPAL_INVESTIGATOR

Lehigh Valley Hospital

Locations

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Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 10353976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8867250 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12042548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15520120 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1517650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19528768 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15601345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19690240 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20003121 (View on PubMed)

Gift AG. Visual analogue scales: measurement of subjective phenomena. Nurs Res. 1989 Sep-Oct;38(5):286-8. No abstract available.

Reference Type BACKGROUND
PMID: 2678015 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20921070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 2197679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18520909 (View on PubMed)

Other Identifiers

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1-20030313

Identifier Type: -

Identifier Source: org_study_id