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Topical Lidocaine Anesthesia for Nasopharyngeal Sampling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04885777
Recruitment Status : Completed
First Posted : May 13, 2021
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Abdullah Osman KOCAK, Ataturk University

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.


Condition or disease Intervention/treatment Phase
Nasopharyngeal Sampling Local Anesthesia Drug: Lidocaine Other: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Topical Lidocaine Anesthesia for Nasopharyngeal Sampling: A Double-blind Randomized Placebo-controlled Trial
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : September 30, 2020
Actual Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lidocaine group
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.
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 Name: nasopharyngeal sampling

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





Primary Outcome Measures :
  1. Changes in the severity of pain during the sampling procedure. [ Time Frame: 2 hours ]
    This outcome will measured via a paper questionnaire that had two Numerical Rating Scale (NRS). The NRSs were 100 mm scales ranging from 0 to 10 (0 as the absence of pain/discomfort and 10 as unbearable pain/discomfort).

  2. Changes in the severity of discomfort during the sampling procedure. [ Time Frame: 2 hours ]
    This outcome will measured via a paper questionnaire that had two Numerical Rating Scale (NRS). The NRSs were 100 mm scales ranging from 0 to 10 (0 as the absence of pain/discomfort and 10 as unbearable pain/discomfort).

  3. Changing the frequency of undesirable reactions [ Time Frame: 2 Hours ]
    Changing the frequency of undesirable reactions during between first and second sample collection. We will record head retraction, holding practitioner staff's hand, grimace, cough, and sneeze as the undesirable reaction during the sampling procedure.

  4. Judgment of the practitioner staff about the sampling procedure [ Time Frame: 2 Hours ]
    We will research the appropriateness and the difficultness of the sample collection procedure, for this outcome. If four steps of the sampling procedure (inserting in the nostril, hitting the back of the nasopharyngeal cavity, rotating five times, and removing) have been completed successfully, it will be defined as the sampling procedure is as appropriate.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04885777


Locations
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Turkey
Ataturk University
Erzurum, Turkey
Sponsors and Collaborators
Ataturk University
Publications:
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Responsible Party: Abdullah Osman KOCAK, Associate Professor of Emergency Department of Ataturk University, Ataturk University
ClinicalTrials.gov Identifier: NCT04885777    
Other Study ID Numbers: Ataturk University0000
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Datas will be sharing via internet.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abdullah Osman KOCAK, Ataturk University:
Lidocaine
Nasopharyngeal sampling
Coronavirus Disease 2019 Testing
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action