Phase 4
Completed N=114
Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
Source: ClinicalTrials.gov NCT00676364 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcomePrimary: Pain From Venipuncture — 2.2; 2.1 scores on a scale — p=0.71
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain From Venipuncture |
2.2; 2.1 | 0.71 |
| SECONDARY Anxiety of Venipuncture |
43.1; 40.5 | — |
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
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. Informational only — not medical advice.