Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs: a Randomized, Double-Blinded, Placebo Controlled-Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Pain during the procedure
研究概览
简要总结
Since the beginning of the COVID-19 pandemic, nasopharyngeal swabs (NPS) have been recommended to detect the virus. This procedure has been reported to be painful by 85% of children The aim of the study was to assess whether pretreatment with topical lidocaine reduces the discomfort experienced by children during a nasopharyngeal swab.
This was a RCT among children aged 8-17 years old who need a NPS. The primary outcome was pain intensity as measured by the Visual Analog Scale .
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The research assistant enrolling the patients was blinded to treatment assignment because he did not know to which bottle the patient was randomized (A or B) and he did not know what was contained in the bottle
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Xylocaine
The study intervention was the administration of 10 mg of intranasal lidocaine in one nostril using 1 spray of 0.1mL of a 10% lidocaine solution 5 minutes before NPS. This was done using the standard long nozzle.
干预措施: Xylocaine (Drug)
Control
The control group received the placebo with the same application technique using an empty bottle of lidocaine 10% with the same long nozzle for delivery.
干预措施: Placebo (Drug)
结局指标
主要结局
Pain during the procedure
时间窗: During procedure
Self-reported pain immediately after the NPS as measured using a validated self-reported pain scale: the Visual Analog Scale (VAS
次要结局
- Anxiety during the procedure(During procedure)
- Discomfort(During procedure)
- Pain 2 NRS(During procedure)
- Number of patients with physical restriction(During procedure)
- Utility according to nurses(During procedure)
- Desire to reuse the intervention in a futur procedure, at follow up(48 hours following intervention)
- Adverse event(48 hours following intervention)
研究者
Evelyne D.Trottier
MD
St. Justine's Hospital