Topical Lidocaine Anesthesia for Nasopharyngeal Sampling

Local Anesthesia Clinical Trial

Official title: Topical Lidocaine Anesthesia for Nasopharyngeal Sampling: A Double-blind Randomized Placebo-controlled Trial

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Local Anesthesia

• NCT number: NCT04885777
• Study type: Interventional
• Source: Ataturk University
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Completion date: October 30, 2020