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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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xylocaine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety during the procedure | ● Evaluation of fear prior to the administration of the study intervention and the NPS using the Children's Fear Scale | During procedure |
| Discomfort | Discomfort at administration of the study intervention using a yes/no question |
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Inclusion:
Exclusion:
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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evelyne D Trottier | Montreal | Quebec | H3T1C5 | Canada |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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The research assistant enrolling the patients was blinded to treatment assignment because he did not know to which bottle the patient was randomized (A or B) and he did not know what was contained in the bottle
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| Placebo | Drug | 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 |
|
| During procedure |
| Pain 2 NRS | Evaluation of pain immediately after the NPS using a clinically relevant tool, the verbal Numeric Rating Scale | 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 | 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 | During procedure |
| Adverse event | Adverse effects reported by caregivers in the 24-48hrs following administration of medication | 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. | 48 hours following intervention |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Aniline Compounds |
| D000588 | Amines |