NCT04885777

Topical Lidocaine Anesthesia for Nasopharyngeal Sampling

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Ataturk University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Nasopharyngeal Sampling
• Local Anesthesia

Interventions

Type	Name	Description
DRUG	Lidocaine	Initially, a nasopharyngeal swab was performed on each group without any intervention. Investigators waited at least one hour for the second sample collection. If the participant was still in pain or felt discomfort due to the first sampling, the waiting time has been extended. At the second stage, 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. The second samples were collected after waiting 5 minutes following the administration of the solution.
OTHER	Placebo	Initially, a nasopharyngeal swab was performed on placebo group without any intervention. Investigators waited at least one hour for the second sample collection. If the participant was still in pain or felt discomfort due to the first sampling, the waiting time has been extended. At the second stage, the Placebo group received only a total of 2 ml of 0.9% NaCl (one ml for each nostril). The second samples were collected after waiting 5 minutes following the administration of the solution.

Timeline

• Start date: 2020-09-01
• Primary completion: 2020-09-30
• Completion: 2020-10-30
• First posted: 2021-05-13
• Last updated: 2021-05-18

Locations

1 site across 1 country: Turkey (Türkiye)