Covid19Phase 2/3XylofunsNCT04901065
Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs
A Phase 2/3 study testing Xylocaine in people with Covid19, run by Evelyne D.Trottier at 1 site in Canada.
Trial summary
Since the beginning of the COVID-19 pandemic, nasopharyngeal swabs (NPS) have been recommended to detect the virus. This procedure has been reported to be painful by 85% of children The aim of the study was to assess whether pretreatment with topical lidocaine reduces the discomfort experienced by children during a… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Covid19
- What is being tested?
- Xylocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteCanada
- Study dates
- 11 May 2021to 7 Jun 2021
- Phase
- Phase 2/3
- 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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6-17 years old inclusively
- Children for whom a NPS was ordered
Who cannot join
- Children presenting with the following acute conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient as increased absorption of the medication might occur:
- Nasal or airway burns, trauma or major anomaly
- Cardiorespiratory compromise
- Children for whom an informed consent could not be obtained
- Any other life-threatening condition or priority one patient requiring emergency support
- Language barrier
Show all 19Show fewer
- Children presenting with conditions that could prevent their ability to reliably report their pain:
- Severe intellectual disability
- Severe pain upon presentation
- Administration of opiates prior to the NPS
- Children presenting with the following chronic conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient:
- Hypersensitivity/allergy to the medication or a known component
- Methemoglobinemia
- G6PD deficiency
- Familial malignant hyperthermia
- Pseudocholinesterase deficiency
- Severe hepatic impairment
- Severe cardiac condition or use of antiarrhythmic medication
- Risk of airway aspiration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs: a Randomized, Double-Blinded, Placebo Controlled-Trial
Since the beginning of the COVID-19 pandemic, nasopharyngeal swabs (NPS) have been recommended to detect the virus. This procedure has been reported to be painful by 85% of children The aim of the study was to assess whether pretreatment with topical lidocaine reduces the discomfort experienced by children during a nasopharyngeal swab.
This was a RCT among children aged 8-17 years old who need a NPS. The primary outcome was pain intensity as measured by the Visual Analog Scale .
- Conditions
- Covid19
- Being tested
- Xylocaine, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XylocaineDrug
Also called Xylocaine spray
The study intervention was the administration of 10 mg of intranasal lidocaine in one nostril using 1 spray of 0.1mL of a 10% lidocaine solution 5 minutes before NPS. This was done using the standard long nozzle
PlaceboDrug
The control group received the placebo with the same application technique using an empty bottle of lidocaine 10% with the same long nozzle for delivery
| Study group | Role | What they receive |
|---|---|---|
| Xylocaine | Experimental | The study intervention was the administration of 10 mg of intranasal lidocaine in one nostril using 1 spray of 0.1mL of a 10% lidocaine solution 5 minutes before NPS. This was done using the standard long nozzle. Receives: Drug: Xylocaine |
| Control | Sham comparator | The control group received the placebo with the same application technique using an empty bottle of lidocaine 10% with the same long nozzle for delivery. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during the procedure
Self-reported pain immediately after the NPS as measured using a validated self-reported pain scale: the Visual Analog Scale (VAS
Measured: During procedure
Secondary outcomes (7)
Anxiety during the procedure
● Evaluation of fear prior to the administration of the study intervention and the NPS using the Children's Fear Scale
Measured: During procedure
Discomfort
Discomfort at administration of the study intervention using a yes/no question
Measured: During procedure
Pain 2 NRS
Evaluation of pain immediately after the NPS using a clinically relevant tool, the verbal Numeric Rating Scale
Measured: During procedure
Number of patients with physical restriction
Evaluation of the patient position (sitting, lying down, standing) and if physical restraints was done (none, redirection of movements, comfort position/minimal comfortable restriction or actively restrain) to perform the swab and to which extent
Measured: During procedure
Utility according to nurses
● Triage nurses evaluation on the efficiency of the intervention in reducing pain in the patient, using a likert scale of 1 to 5
Measured: During procedure
Adverse event
Adverse effects reported by caregivers in the 24-48hrs following administration of medication
Measured: 48 hours following intervention
Desire to reuse the intervention in a futur procedure, at follow up
Asking caregivers in the 24-48hrs following intervention if they would recommend the intervention before a NPS as standard of care for pediatric patients. Yes/no question.
Measured: 48 hours following intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start11 May 2021
- Primary completion7 Jun 2021
- Study completion7 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evelyne D.Trottier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Evelyne D.Trottier, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901065
- Sponsor's protocol ID
- 2021-3414
- Acronym
- Xylofuns
- Status last verified
- Sep 2021
- First submitted
- 14 May 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs: a Randomized, Double-Blinded, Placebo Controlled-Trial
- ClinicalTrials.gov ID
- NCT04901065
- Acronym / sponsor ID
- Xylofuns / 2021-3414
- Conditions
- Covid19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Evelyne D.TrottierUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 7 Jun 2021 (actual)
- Study completion
- 7 Jun 2021 (actual)
- First posted
- 25 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.
Since the beginning of the COVID-19 pandemic, nasopharyngeal swabs (NPS) have been recommended to detect the virus. This procedure has been reported to be painful by 85% of children The aim of the study was to assess whether pretreatment with topical lidocaine reduces the discomfort experienced by children during a nasopharyngeal swab.
This was a RCT among children aged 8-17 years old who need a NPS. The primary outcome was pain intensity as measured by the Visual Analog Scale .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylocaine | Experimental | Drug: XylocaineThe study intervention was the administration of 10 mg of intranasal lidocaine in one nostril using 1 spray of 0.1mL of a 10% lidocaine solution 5 minutes before NPS. This was done using the standard long nozzle. |
| Control | Sham comparator | Drug: PlaceboThe control group received the placebo with the same application technique using an empty bottle of lidocaine 10% with the same long nozzle for delivery. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6-17 years old inclusively
- Children for whom a NPS was ordered
Key exclusion criteria (19 listed)
- Children presenting with the following acute conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient as increased absorption of the medication might occur:
- Children for whom an informed consent could not be obtained
- Children presenting with conditions that could prevent their ability to reliably report their pain:
- Children presenting with the following chronic conditions, which could either prevent the lidocaine from being properly administered, or pose a risk for the patient:
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 |
|---|---|---|
| XylocaineAlso: Xylocaine sprayThe study intervention was the administration of 10 mg of intranasal lidocaine in one nostril using 1 spray of 0.1mL of a 10% lidocaine solution 5 minutes before NPS. This was done using the standard long nozzle | Drug | Xylocaine |
| PlaceboThe control group received the placebo with the same application technique using an empty bottle of lidocaine 10% with the same long nozzle for delivery | Drug | Control |
Primary outcome
Pain during the procedure
Time frame: During procedure
Self-reported pain immediately after the NPS as measured using a validated self-reported pain scale: the Visual Analog Scale (VAS
7 secondary outcomes
Anxiety during the procedure
Time frame: During procedure
Discomfort
Time frame: During procedure
Pain 2 NRS
Time frame: During procedure
Number of patients with physical restriction
Time frame: During procedure
Utility according to nurses
Time frame: During procedure
Adverse event
Time frame: 48 hours following intervention
Desire to reuse the intervention in a futur procedure, at follow up
Time frame: 48 hours following intervention
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 27 Sep 2021.
- Individual participant dataSharing planned: No
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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 Phase 2/3 study testing Xylocaine in people with Covid19, run by Evelyne D.Trottier at 1 site in Canada.
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 2 inclusion and 19 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 27 Sep 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 Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pain during the procedure (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2021.