Evelyne D Trottier
Montreal, Quebec, H3T1C5, Canada
NCT Number: NCT04901065
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 .
Looking for future studies?
Notify Me8 year–17 year
All sexes
Interventional
Phase 2 / Phase 3
Montreal, Quebec, H3T1C5, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion:
Exclusion:
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
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
Time frame: During procedure
Self-reported pain immediately after the NPS as measured using a validated self-reported pain scale: the Visual Analog Scale (VAS
Time frame: During procedure
● Evaluation of fear prior to the administration of the study intervention and the NPS using the Children's Fear Scale
Time frame: During procedure
Discomfort at administration of the study intervention using a yes/no question
Time frame: During procedure
Evaluation of pain immediately after the NPS using a clinically relevant tool, the verbal Numeric Rating Scale
Time frame: 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
Time frame: 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
Time frame: 48 hours following intervention
Adverse effects reported by caregivers in the 24-48hrs following administration of medication
Time frame: 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.
Evelyne D.Trottier
Other
Xylocaine to Freeze During Unpleasant Nasopharyngeal Swabs: a Randomized, Double-Blinded, Placebo Controlled-Trial
Acronym: Xylofuns
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04747249
COVID-19, Coronaviridae Infections
Caen, France
View Trial DetailsNCT04924881
COVID-19, Coronaviridae Infections
Shatin, Hong Kong
View Trial DetailsNCT04939506
Behavior, COVID-19
New Orleans, Louisiana, United States
View Trial DetailsNCT04705116
COVID-19, Coronaviridae Infections
Los Angeles, California, United States
View Trial Details