Topical Lidocaine Anesthesia for Nasopharyngeal Sampling

Ataturk University

Status: Completed

Conditions: Nasopharyngeal Sampling; Local Anesthesia

Treatments: Other: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04885777

Ataturk University0000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The inclusion criteria of the study is:

• being 18 years and older
• volunteering to participate in the study.

Exclusion criteria

• 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.).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups, including a placebo group

Lidocaine group

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine

Placebo group

Placebo Comparator group

Description:

The Placebo group received only a total of 2 ml of 0.9% NaCl (one ml for each nostril).

Treatment:

Other: Placebo