Phase 4 N=114 Randomized Triple-blind Treatment

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

Pain · Anxiety

Bottom Line

View on ClinicalTrials.gov: NCT00676364 ↗

Enrolled (actual)

114

Serious AEs

0.0%

Results posted

Sep 2012

Primary outcome: Primary: Pain From Venipuncture — 2.2; 2.1 scores on a scale — p=0.71

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: 4% lidocaine topical anesthetic cream (Drug); Placebo cream (Drug)
Age: Pediatric, Adult · 5+ yrs
Sex: All
Sponsor: Jenny Boucher, PharmD
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain From Venipuncture	2.2; 2.1	0.71
SECONDARY Anxiety of Venipuncture	43.1; 40.5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00676364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.