Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs

Phase 2

Completed

• Conditions: Covid19
• Interventions: Drug: Xylocaine; Drug: Placebo

• Registration Number: NCT04901065
• Lead Sponsor: Evelyne D.Trottier

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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-11
• Study First Submitted: 2021-05-14
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-25
• Primary Completion: 2021-06-07
• Study Completion: 2021-06-07
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-21
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Xylocaine	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.
Control	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Discomfort	During procedure	Discomfort at administration of the study intervention using a yes/no question
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
Pain 2 NRS	During procedure	Evaluation of pain immediately after the NPS using a clinically relevant tool, the verbal Numeric Rating Scale
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
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
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.
Adverse event	48 hours following intervention	Adverse effects reported by caregivers in the 24-48hrs following administration of medication

Trial Locations

Locations (1)

Evelyne D Trottier; 🇨🇦 Montreal, Quebec, Canada