Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs (Xylofuns)

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 .

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Xylocaine; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3T1C5
      • Evelyne D Trottier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Xylocaine; 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; 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; Other Names: Xylocaine spray
SHAM_COMPARATOR: Control; 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Evelyne D.Trottier

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2021
• Primary Completion (ACTUAL): June 7, 2021
• Study Completion (ACTUAL): June 7, 2021

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (ACTUAL): May 25, 2021

Study Record Updates

• Last Update Posted (ACTUAL): September 27, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

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: 2021-3414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No