COVID Infection in Pediatric Surgical Patient
- Conditions
- COVID-19
- Registration Number
- NCT05898529
- Lead Sponsor
- Salem Anaesthesia Pain Clinic
- Brief Summary
Children infected with COVID-19 are mostly asymptomatic. There is a dearth of data on the epidemiology of COVID-19 in the pediatric population. This is a prospective observational clinical study of pediatric surgical patients. COVID-19 rapid antigen testing will be performed on pediatric patients.
- Detailed Description
Children infected with COVID-19 are mostly asymptomatic or mildly symptomatic. Children may spread COVID-19 to the elderly, vulnerable patients and medical staff. There is a dearth of data on the epidemiology of COVID-19 in the pediatric surgical population. Rapid antigen detection tests for the diagnosis of COVID-19 are reliable, simple, fast, and inexpensive.
This is a prospective observational clinical study. The study population will include all consenting pediatric surgical patients, aged 2-17 years. Informed consent will be obtained from each patient and the legal guardian who agree to participate in the study. Nasopharyngeal swab specimens will be collected from anesthetized pediatric patients. COVID-19 rapid antigen testing will be performed according to the equipment manufacturer's instructions.
Data collection will include COVID-19 test result, nasal swab complication, patient demographics, surgical history, medical history, regular medications, COVID-19 symptoms, and COVID-19 exposure information. COVID-19 symptoms that will be recorded are cough, wheeze, nasal congestion, breathing difficulty, new loss of taste or smell, fever, chills, rigors, body aches, sore throat, nausea, and fatigue. COVID-19 exposure will be considered as being within 6 feet of a person with diagnosed COVID-19 infection in the previous 14 days.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 350
- surgical patients aged 2-17 years
- informed consent for surgery
- no COVID-19 diagnosis in previous 6 months
- no history of nasal bleeding
- no history of coagulopathy.
- patient refusal of testing
- difficulty in obtaining consent
- COVID-19 diagnosis in recent 6 month
- history of nasal bleeding
- history of coagulopathy.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Antigen test positive result 1 day COVID-19 antigen test positive
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Salem Anaesthesia Pain Clinic
🇨🇦Surrey, British Columbia, Canada