Status:
RECRUITING
Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.
Lead Sponsor:
Telethon Kids Institute
Collaborating Sponsors:
Child and Adolescent Health Service - Perth
Hospital das Clínicas de São Paulo - SP
Conditions:
Perioperative Respiratory Adverse Events
Anesthesia Outcomes
Eligibility:
All Genders
1-8 years
Phase:
PHASE4
Brief Summary
The goal of this multicentre, double-blind, randomised controlled trial study is to learn if the use of a nasal spray to open the nasal passages and increase airflow before surgery can reduce the occu...
Detailed Description
Upper respiratory tract infections (URTI), including COVID-19 infection and the common cold, are common and frequent in children who present for elective surgery. Children with URTI are at a two-to-th...
Eligibility Criteria
Inclusion
- Children aged 1 to 8.99 years with a current or recent upper respiratory tract infection (\<2 weeks).
- Undergoing interventions or surgery under general anesthesia (elective or urgent not emergency).
Exclusion
- Currently taking nasal decongestants (past 24 hours) or receiving co-phenylocaine or decongestion for surgery.
- Surgery impacting the nasal airflow, e.g. adenoidectomy, cautery of inferior turbinates.
- Airway management with an endotracheal tube, face mask or high flow nasal oxygen.
- Known cardiovascular, respiratory or neurological disorders giving an ASA III or above.
- Thyroid disease.
- Diabetes.
- Known hypersensitivity to the interventional products.
- Department of Child Protection and Family Services involved in their care.
- Planned admissions to the Paediatric Intensive Care Unit (PICU).
Key Trial Info
Start Date :
June 25 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07000877
Start Date
June 25 2025
End Date
May 30 2028
Last Update
November 19 2025
Active Locations (1)
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1
Perth Children's Hospital
Perth, We, Australia