Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs

NCT04901065 | Completed Phase 2

• 1 other identifier: 2021-3414
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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 .

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Anxiety during the procedure

  During procedure

• Discomfort

  During procedure

• Pain 2 NRS

  During procedure

• Number of patients with physical restriction

  During procedure

• Utility according to nurses

  During procedure

Study Arms (2)

Xylocaine

EXPERIMENTAL

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

Control

SHAM COMPARATOR

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

Interventions

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

Also known as: Xylocaine spray

Xylocaine

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

Control

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• years old inclusively
• Children for whom a NPS was ordered

You may not qualify if:

• 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

Sponsors & Collaborators

• Evelyne D.Trottier: lead

Study Sites (1)

Evelyne D Trottier

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

COVID-19

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 25, 2021
• Study Start: May 11, 2021
• Primary Completion: June 7, 2021
• Study Completion: June 7, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)