Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs

Study Overview
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Brief Summary
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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 .

Official Title
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Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs: a Randomized, Double-Blinded, Placebo Controlled-Trial

Conditions
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Covid19

Intervention / Treatment
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* Drug: Xylocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion: 6-17 years old inclusively Children for whom a NPS was ordered 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: 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 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

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Xylocaine<br>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. | Drug: Xylocaine<br>* 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<br>* Other names: Xylocaine spray;|
| Sham Comparator: Control<br>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. | Drug: Placebo<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |