Topical Lidocaine Anesthesia for Nasopharyngeal Sampling
Condition: Nasopharyngeal Sampling; Local Anesthesia
Study type: Interventional

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.
    

Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 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.; 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.
Other intervention name(s): nasopharyngeal sampling
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Lidocaine; Nasopharyngeal sampling; Coronavirus Disease 2019 Testing