Topical Lidocaine Anesthesia for Nasopharyngeal Sampling: A Double-blind Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Changes in the severity of pain during the sampling procedure.
研究概览
简要总结
Introduction: Nasopharyngeal sampling is widely used in the diagnosis of the Coronavirus Disease 2019 (COVID-19). The aim of this study is to evaluate the effects of topical lidocaine application for nasopharyngeal sampling, on pain perception, the comfort of the patients, and the application difficulty for healthcare staff.
Methods: This study is a prospective randomized placebo-controlled study conducted with 100 healthy volunteers (50 participants in Lidocaine group and 50 participants in Placebo group). Two ml of a solution containing 10 mg/ml of lidocaine was applied to each nostril of the participants in the Lidocaine group, and the same dose of 0.9% NaCl to the Placebo group. Investigators performed two repeated sampling one hour apart. The first sampling was performed before intervention, and the second was performed five-minutes after intervention. Investigators compared the changes in pain intensity and discomfort intensity using two numerical rating scales, the frequency of undesirable reactions, and the judgment of the practitioner staff about the sampling procedure between first and second sampling.
详细描述
This study is a prospective randomized placebo-controlled study with restricted randomization of an allocation ratio of 1:1. We used Random Allocation Software (RAS) for randomization. The study is conducted following the CONSORT guideline and the tenets of the Declaration of Helsinki we obtained the approval of the Ataturk University Clinical Research Ethics Committee. Also, the written informed consent of all participants will obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The inclusion criteria of the study is:
- •being 18 years and older
- •volunteering to participate in the study.
排除标准
- •The exclusion criteria of the study is:
- •taking analgesic drugs before admission,
- •pregnancy,
- •lactation,
- •having a bleeding disorder, *known allergy to Lidocaine, * previous nasal trauma or operation,
- •having respiratory tract infection symptoms (such as fever, headache, runny nose, sore throat, cough, sneeze, breathlessness),
- •having a chronic disease (diabetes, cancer, heart disease, asthma, COPD, etc.).
研究组 & 干预措施
Lidocaine group
One ml of a solution containing 20 mg/ml of lidocaine was applied to each nostril of the participants in the Lidocaine group. Thus, a total of 40 mg of lidocaine, 20 mg for each nostril, was given to the individuals of the Lidocaine group.
干预措施: Lidocaine (Drug)
Placebo group
The Placebo group received only a total of 2 ml of 0.9% NaCl (one ml for each nostril).
干预措施: Placebo (Other)
结局指标
主要结局
Changes in the severity of pain during the sampling procedure.
时间窗: 2 hours
This outcome will measured via a paper questionnaire that had two Numerical Rating Scale (NRS). The NRSs were 100 mm scales ranging from 0 to 10 (0 as the absence of pain/discomfort and 10 as unbearable pain/discomfort).
Changes in the severity of discomfort during the sampling procedure.
时间窗: 2 hours
This outcome will measured via a paper questionnaire that had two Numerical Rating Scale (NRS). The NRSs were 100 mm scales ranging from 0 to 10 (0 as the absence of pain/discomfort and 10 as unbearable pain/discomfort).
Changing the frequency of undesirable reactions
时间窗: 2 Hours
Changing the frequency of undesirable reactions during between first and second sample collection. We will record head retraction, holding practitioner staff's hand, grimace, cough, and sneeze as the undesirable reaction during the sampling procedure.
Judgment of the practitioner staff about the sampling procedure
时间窗: 2 Hours
We will research the appropriateness and the difficultness of the sample collection procedure, for this outcome. If four steps of the sampling procedure (inserting in the nostril, hitting the back of the nasopharyngeal cavity, rotating five times, and removing) have been completed successfully, it will be defined as the sampling procedure is as appropriate.
次要结局
未报告次要终点
研究者
Abdullah Osman KOCAK
Associate Professor of Emergency Department of Ataturk University
Ataturk University