Title
Randomized Control Trial of a Topical Anesthetic to Evaluate Pain and Anxiety During Venipuncture
A Randomized, Placebo-Controlled Trial to Evaluate Pain and Anxiety During Venipuncture in Pediatric Patients With or Without Pre-treatment by a Topical Anesthetic
Phase
Phase 4Lead Sponsor
Lehigh Valley HospitalStudy Type
InterventionalStatus
Completed Results PostedIntervention/Treatment
lidocaine ...Study Participants
114The 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.
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).
A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture
A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture
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.
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
| Event Type | Organ System | Event Term |
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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.
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.
