Expired Study
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Allentown, Pennsylvania 18103


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 numbing cream or a fake cream with no medication in it.


Study summary:

Pediatric patients frequently receive 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 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).


Criteria:

Inclusion Criteria: - childern ages 5-18 years of age - treated as an inpatient or outpatient at LVH 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 (GCS <15) - congnitively impaired (MMSE <28) - active skin conditions at venipuncture site including frequent rashes, eczema or unexplained bruising


Study is Available At:


Original ID:

1-20030313


NCT ID:

NCT00676364


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

5 Years


Maximum Age:

18 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Lehigh Valley Hospital


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jenny Boucher, PharmD
Principal Investigator
Lehigh Valley Hospital

Study Dates

Start Date:March 2003
Completion Date:February 2008
Completion Type:Actual
Primary Completion Date:February 2008
Primary Completion Type:Actual
Verification Date:July 2011
Last Changed Date:July 14, 2011
First Received Date:May 9, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:anxiety of venipuncture
Time Frame:15mins before, at, and 30mins after venipuncture
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Pain during venipuncture
Time Frame:at venipuncture
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:LMX-4
Description:4% lidocaine topical
Arm Name:I
Other Name:4% liposomal lidocaine

Study Arms

Study Arm Type:Experimental
Arm Name:I
Description:Experimential group receiving medicated topical cream prior to venipuncture

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Lehigh Valley Hospital

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Cooper CM, Gerrish SP, Hardwick M, Kay R. EMLA cream reduces the pain of venepuncture in children. Eur J Anaesthesiol. 1987 Nov;4(6):441-8.
PMID:3328685
Reference Type:Reference
Citation:Luhmann J, Hurt S, Shootman M, Kennedy R. A comparison of buffered lidocaine versus ELA-Max before peripheral intravenous catheter insertions in children. Pediatrics. 2004 Mar;113(3 Pt 1):e217-20.
PMID:14993579
Reference Type:Reference
Citation:Arts SE, Abu-Saad HH, Champion GD, Crawford MR, Fisher RJ, Juniper KH, Ziegler JB. Age-related response to lidocaine-prilocaine (EMLA) emulsion and effect of music distraction on the pain of intravenous cannulation. Pediatrics. 1994 May;93(5):797-801. Review.
PMID:8165081
Reference Type:Reference
Citation:Chang PC, Goresky GV, O'Connor G, Pyesmany DA, Rogers PC, Steward DJ, Stewart JA. A multicentre randomized study of single-unit dose package of EMLA patch vs EMLA 5% cream for venepuncture in children. Can J Anaesth. 1994 Jan;41(1):59-63.
PMID:8111946
Reference Type:Reference
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.
PMID:10353976
Reference Type:Reference
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.
PMID:8867250

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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