Conditions: Pain Anxiety
Keywords: pediatric patients pain anxiety topical anesthetic randomized control trial
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 114
Healthy volunteers: yes

Brief 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.

Detailed description:
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).

Arms:
arm 1: This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick. arm 2: This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.

Interventions: intervention 1: 4% lidocaine topical anesthetic cream intervention 2: Placebo cream
Intervention descriptions: intervention 1: A dollop of 4% lidocaine cream was applied under occlusive dressing for 15 mins prior to venipuncture intervention 2: A dollop of matching placebo cream was applied under occlusive dressing for 15 mins prior to venipuncture

Protocol document: