Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs

Covid19 Clinical Trial

— Xylofuns  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901065
• Other study ID #: 2021-3414
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 11, 2021
• Est. completion date: June 7, 2021

Study information

• Verified date: September 2021
• Source: St. Justine's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

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
• 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

Locations

Country	Name	City	State
Canada	Evelyne D Trottier	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Evelyne D.Trottier

Country where clinical trial is conducted

Canada, 

Outcome

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