A Randomized, Placebo-Controlled Trial to Evaluate Pain and Anxiety During Venipuncture in Pediatric Patients With or Without Pre-treatment by a Topical Anesthetic
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Pain From Venipuncture
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
4% lidocaine topical anesthetic cream
This group received topical 4% lidocaine anesthetic cream under occlusive dressing for 15 minutes prior to needle stick.
干预措施: 4% lidocaine topical anesthetic cream (Drug)
Placebo
This group received matching placebo cream under occlusive dressing for 15 minutes prior to needle stick.
干预措施: Placebo cream (Drug)
结局指标
主要结局
Pain From Venipuncture
时间窗: Pain was measured immediately after venipuncture.
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.
次要结局
- Anxiety of Venipuncture(During venipuncture)
研究者
Jenny Boucher, PharmD
Investigator
Lehigh Valley Hospital