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Xylofuns: Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs

Sponsor
Evelyne D.Trottier (Other)
Overall Status
Completed
CT.gov ID
NCT04901065
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
27
Actual Duration (Days)
99.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 .

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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
Primary Purpose:
Treatment
Official Title:
Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs: a Randomized, Double-Blinded, Placebo Controlled-Trial
Actual Study Start Date :
May 11, 2021
Actual Primary Completion Date :
Jun 7, 2021
Actual Study Completion Date :
Jun 7, 2021

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Pain during the procedure [During procedure]

      Self-reported pain immediately after the NPS as measured using a validated self-reported pain scale: the Visual Analog Scale (VAS

    Secondary Outcome Measures

    1. Anxiety during the procedure [During procedure]

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

    2. Discomfort [During procedure]

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

    3. Pain 2 NRS [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 [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 [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 [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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Evelyne D Trottier Montreal Quebec Canada H3T1C5

    Sponsors and Collaborators

    • Evelyne D.Trottier

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Evelyne D.Trottier, MD, St. Justine's Hospital
    ClinicalTrials.gov Identifier:
    NCT04901065
    Other Study ID Numbers:
    • 2021-3414
    First Posted:
    May 25, 2021
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Lidocaine

    Study Results

    No Results Posted as of Sep 27, 2021