Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs (Xylofuns)

Evelyne D.Trottier

Status and phase: Completed; Phase 3; Phase 2

Conditions: Covid19

Treatments: Drug: Placebo; Drug: Xylocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04901065

2021-3414

Details and patient eligibility

About

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 .

Enrollment: 88 patients

Sex: All

Ages: 8 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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88 participants in 2 patient groups

Xylocaine

Experimental group

Description:

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.

Treatment:

Drug: Xylocaine

Control

Sham Comparator group

Description:

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.

Treatment:

Drug: Placebo