Nasopharyngeal SamplingNCT04885777
Topical Lidocaine Anesthesia for Nasopharyngeal Sampling
A study testing Lidocaine in people with Nasopharyngeal Sampling and Local Anesthesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasopharyngeal Sampling, Local Anesthesia
- What is being tested?
- Lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
- The inclusion criteria of the study is:
- being 18 years and older
- volunteering to participate in the study.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Nasopharyngeal Sampling, Local Anesthesia
- Being tested
- Lidocaine, Placebo
- Keywords
- Lidocaine, Nasopharyngeal sampling, Coronavirus Disease 2019 Testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called nasopharyngeal sampling
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.
PlaceboOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Active comparator | 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. Receives: Drug: Lidocaine |
| Placebo group | Placebo comparator | The Placebo group received only a total of 2 ml of 0.9% NaCl (one ml for each nostril). Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the severity of pain during the sampling procedure.
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).
Measured: 2 hours
Changes in the severity of discomfort during the sampling procedure.
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).
Measured: 2 hours
Changing the frequency of undesirable reactions
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.
Measured: 2 Hours
Judgment of the practitioner staff about the sampling procedure
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.
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Sep 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Nasopharyngeal SamplingStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Osman KOCAK, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885777
- Sponsor's protocol ID
- Ataturk University0000
- Status last verified
- May 2021
- First submitted
- 8 May 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datas will be sharing via internet.
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.
PubMed 32542934Tolia 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.
PubMed 32223871Petruzzi 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.
PubMed 32352180Tsujimoto 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.
PubMed 33760699
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Lidocaine Anesthesia for Nasopharyngeal Sampling: A Double-blind Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04885777
- Acronym / sponsor ID
- Ataturk University0000
- Conditions
- Nasopharyngeal Sampling, Local Anesthesia
- Keywords
- Lidocaine, Nasopharyngeal sampling, Coronavirus Disease 2019 Testing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 13 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Active comparator | Drug: LidocaineOne 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. |
| Placebo group | Placebo comparator | Other: PlaceboThe Placebo group received only a total of 2 ml of 0.9% NaCl (one ml for each nostril). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -
- being 18 years and older
- volunteering to participate in the study.
Key exclusion criteria (7 listed)
- The exclusion criteria of the study is:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LidocaineAlso: nasopharyngeal samplingInitially, 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. | Drug | Lidocaine group |
| PlaceboInitially, 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 | Placebo group |
Primary outcome
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).
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).
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Background: PubMed 32542934Carpenter 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.
- Background: PubMed 32223871Tolia 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.
- Background: PubMed 32352180Petruzzi 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.
- Background: PubMed 33760699Tsujimoto 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.
- Individual participant dataSharing planned: Yes. Datas will be sharing via internet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine in people with Nasopharyngeal Sampling and Local Anesthesia, run by Ataturk University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the severity of pain during the sampling procedure. (time frame: 2 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04885777, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.