Clinical trial NCT04885777: Topical Lidocaine Anesthesia for Nasopharyngeal Sampling
Official title: Topical Lidocaine Anesthesia for Nasopharyngeal Sampling: A Double-blind Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasopharyngeal Sampling
Local Anesthesia
Keywords: Lidocaine
Nasopharyngeal sampling
Coronavirus Disease 2019 Testing
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2021-05-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Changes in the severity of pain during the sampling procedure.
timeFrame: 2 hours
measure: Changes in the severity of discomfort during the sampling procedure.
timeFrame: 2 hours
measure: Changing the frequency of undesirable reactions
timeFrame: 2 Hours
measure: Judgment of the practitioner staff about the sampling procedure
timeFrame: 2 Hours
Secondary outcomes:
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Carpenter CR, Mudd PA, West CP, Wilber E, Wilber ST. Diagnosing COVID-19 in the Emergency Department: A Scoping Review of Clinical Examinations, Laboratory Tests, Imaging Accuracy, and Biases. Acad Emerg Med. 2020 Aug;27(8):653-670. doi: 10.1111/acem.14048. Epub 2020 Jul 26.
citation: Tolia VM, Chan TC, Castillo EM. Preliminary Results of Initial Testing for Coronavirus (COVID-19) in the Emergency Department. West J Emerg Med. 2020 Mar 27;21(3):503-506. doi: 10.5811/westjem.2020.3.47348.
citation: Petruzzi G, De Virgilio A, Pichi B, Mazzola F, Zocchi J, Mercante G, Spriano G, Pellini R. COVID-19: Nasal and oropharyngeal swab. Head Neck. 2020 Jun;42(6):1303-1304. doi: 10.1002/hed.26212. Epub 2020 Apr 30.
citation: Tsujimoto Y, Terada J, Kimura M, Moriya A, Motohashi A, Izumi S, Kawajiri K, Hakkaku K, Morishita M, Saito S, Takumida H, Watanabe H, Tsukada A, Morita C, Yamaguchi Y, Katsuno T, Kusaba Y, Sakamoto K, Hashimoto M, Suzuki M, Takasaki J, Hojo M, Miyoshi-Akiyama T, Sugiyama H. Diagnostic accuracy of nasopharyngeal swab, nasal swab and saliva swab samples for the detection of SARS-CoV-2 using RT-PCR. Infect Dis (Lond). 2021 Aug;53(8):581-589. doi: 10.1080/23744235.2021.1903550. Epub 2021 Mar 24.