Actively Recruiting
Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.
Led by Telethon Kids Institute · Updated on 2025-11-19
200
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
T
Telethon Kids Institute
Lead Sponsor
C
Child and Adolescent Health Service - Perth
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 occurrence of perioperative respiratory adverse events in children with upper respiratory tract infection who are undergoing anesthesia. The main questions it aims to answer are: * Does use of a nasal decongestant (Oxymetazoline 0.05%) reduce perioperative respiratory adverse events during emergence (when waking up from anesthesia) or in the post-anesthesia care unit in children. * Is it easy and acceptable to doctors, children and parents to use the nasal decongestant treatment? Researchers will compare the nasal decongestant to a placebo (a look-alike substance that contains no drug) to see if it works to reduce perioperative respiratory adverse effects. Participants will: * Take a nasal decongestant or a placebo prior to surgery (just before anaesthesia is given) * Be monitored during and after surgery in the post-anaesthesia care unit for any perioperative respiratory adverse events. * Be asked about how acceptable they found the treatment.
CONDITIONS
Official Title
Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 1 to 8.99 years with a current or recent upper respiratory tract infection (less than 2 weeks).
- Scheduled for surgery or intervention under general anesthesia (elective or urgent, not emergency).
You will not qualify if you...
- Use of nasal decongestants within the past 24 hours or receiving co-phenylocaine or nasal decongestant treatment for surgery.
- Surgery affecting nasal airflow, such as adenoidectomy or cautery of inferior turbinates.
- Airway managed by endotracheal tube, face mask, or high flow nasal oxygen.
- Known cardiovascular, respiratory, or neurological disorders classified as ASA III or higher.
- Thyroid disease.
- Diabetes.
- Known allergy to the study nasal sprays.
- Involvement of Department of Child Protection and Family Services in care.
- Planned admission to the Pediatric Intensive Care Unit (PICU).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Perth Children's Hospital
Perth, We, Australia
Actively Recruiting
Research Team
B
Britta S. von Ungern-Sternberg, MD PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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