Actively Recruiting

Phase 4
Age: 1Year - 8Years
All Genders
NCT07000877

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

Age: 1Year - 8Years
All Genders

Eligibility Criteria

Eligible

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).
Not Eligible

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

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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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