- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885777
Topical Lidocaine Anesthesia for Nasopharyngeal Sampling
Topical Lidocaine Anesthesia for Nasopharyngeal Sampling: A Double-blind Randomized Placebo-controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Erzurum, Turkey
- Ataturk University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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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.).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 Names:
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Placebo Comparator: Placebo group
The Placebo group received only a total of 2 ml of 0.9% NaCl (one ml for each nostril).
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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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the severity of pain during the sampling procedure.
Time Frame: 2 hours
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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).
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2 hours
|
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).
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2 hours
|
Changing the frequency of undesirable reactions
Time Frame: 2 Hours
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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.
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2 Hours
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Judgment of the practitioner staff about the sampling procedure
Time Frame: 2 Hours
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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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2 Hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- Ataturk University0000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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