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Completed

NCT Number: NCT04901065

Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs

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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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Evelyne D Trottier

Montreal, Quebec, H3T1C5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Xylocaine spray

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Anxiety during the procedure

    Time frame: During procedure

    ● Evaluation of fear prior to the administration of the study intervention and the NPS using the Children's Fear Scale

  2. Discomfort

    Time frame: During procedure

    Discomfort at administration of the study intervention using a yes/no question

  3. Pain 2 NRS

    Time frame: During procedure

    Evaluation of pain immediately after the NPS using a clinically relevant tool, the verbal Numeric Rating Scale

  4. Number of patients with physical restriction

    Time frame: During procedure

    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

  5. Utility according to nurses

    Time frame: During procedure

    ● Triage nurses evaluation on the efficiency of the intervention in reducing pain in the patient, using a likert scale of 1 to 5

  6. Adverse event

    Time frame: 48 hours following intervention

    Adverse effects reported by caregivers in the 24-48hrs following administration of medication

  7. Desire to reuse the intervention in a futur procedure, at follow up

    Time frame: 48 hours following intervention

    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.

Sponsors and collaborators

Lead sponsor

Evelyne D.Trottier

Other

Registry information

Official study title

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

Acronym: Xylofuns

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 25, 2021
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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