Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs

NCT ID: NCT04901065

Last Updated: 2021-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-11
• Study Completion Date: 2021-06-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Xylocaine

Intervention Type: 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

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.

Group Type: SHAM_COMPARATOR

Placebo

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

Xylocaine spray

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Evelyne D.Trottier

OTHER

Sponsor Role: lead

Responsible Party

Evelyne D.Trottier

MD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Evelyne D Trottier

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

2021-3414

Identifier Type: -

Identifier Source: org_study_id