Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Perioperative Respiratory Adverse Events, Anesthesia Outcomes

In brief

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.

Key facts

Study ID

NCT07000877

Run by

Telethon Kids Institute

People needed

200

Starts

2025-06-25

Expected to finish

2028-05-30

Last updated by the study team

2025-11-19

Who can join

Age: 1 and older, up to 8. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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).

Where it is running

• Perth Children's Hospital — Perth, We, Australia (enrolling)

Full record on ClinicalTrials.gov

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