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

NCT07000877 | Recruiting Phase 4 DMC

• 1 other identifier: RGS0000007387
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Perioperative Respiratory Adverse Events; Anesthesia Outcomes

Keywords

perioperative respiratory adverse events; nasal decongestant; upper respiratory tract infection; Children; surgery; pediatrics; anesthesia

Outcome Measures

Primary Outcomes (1)

• Incidence of perioperative respiratory adverse event (PRAE) following the delivery of a nasal decongestant (Oxymetazoline 0.05%) or placebo prior to surgery under anesthesia in children with upper respiratory tract infection

  PRAE will be defined as laryngospasm, bronchospasm, severe persistant coughing, hypoxaemia (\<95% for at least 10 seconds), airway obstruction, stridor or pulmonary aspiration. Incidence will be assessed by the clinician caring for the patient. Incidence is binary - yes if PRAE occured, no otherwise.

  On day of surgery: Perioperative period. PRAE will be assessed if it occurs anywhere along the perioperative pathway between the beginning of the patient's emergence from anesthesia and their discharge from the post-anesthetic care unit (PACU)

Secondary Outcomes (6)

• Assess the incidence of severe PRAE during emergence or in PACU in children who received the decongestant spray compared to the control group.

  Day of surgery: Perioperative period. Severe PRAE will be assessed if it occurs anywhere along the perioperative pathway between the beginning of the patient's emergence from anesthesia and their discharge from the post-anesthetic care unit (PACU)

• Assess the incidence of minor PRAE during emergence or in PACU inchildren who recieved the decongestant spray compared to the control group.

  Day of surgery: Perioperative period. Minor PRAE will be assessed if it occurs anywhere along the perioperative pathway between the beginning of the patient's emergence from anesthesia and their discharge from the post-anesthetic care unit (PACU)

• Evaluate the acceptability of nasal decongestant use at the induction of anesthesia in children with upper respiratory tract infection aged 4 and older and their parents/guardians

  Patients and parents/guardians will be asked to rate the intervention post-operatively, prior to their discharge from hospital.

• Evaluate the acceptability of nasal decongestant use at the induction of anesthesia by the treating anaesthetist

  Treating anaesthetists will be asked to rate the intervention immediately after the administration of the interventional product.

• Incidence of any potential adverse effects related to the administration of the nasal decongestant/placebo

  Any potential adverse effects will be assessed from the administration of the interventional product until the patient's discharge from hospital.

Study Arms (2)

Decongestant nasal spray (oxymetazoline hydrochloride 0.05%)

ACTIVE COMPARATOR

Decongestant nasal spray, oxymetazoline (0.05%). Specific: 2.5mL of oxymetazoline 0.05% dispensed into amber brown 15ml bottles with pump and actuator attached. Children aged 1 to 5.99 years will receive 1 spray of either the nasal decongestant or placebo into each nostril, while children aged 6 years and above will receive 2 spays per nostril. Administration will be recorded on the standard patient's Medication Chart.

Drug: Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))

Placebo Comparator : Placebo spray (control group)

PLACEBO COMPARATOR

Matched Placebo spray. Specific: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02% dispensed into amber brown 15ml bottles with pump and actuator attached. Dose: children aged 1 to 5.99 years will receive 1 spray of either the nasal decongestant or placebo into each nostril, while children aged 6 years and above will receive 2 spays per nostril. Administration will be recorded on the standard patient's Medication Chart.

Drug: PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%

Interventions

Decongestant nasal spray (oxymetazoline hydrochloride (0.05%)) DRUG

Decongestant nasal spray containing active ingredient.

Decongestant nasal spray (oxymetazoline hydrochloride 0.05%)

PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02% DRUG

Control nasal spray containing no active ingredient.

Placebo Comparator : Placebo spray (control group)

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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).

Sponsors & Collaborators

• Telethon Kids Institute: lead
• Child and Adolescent Health Service - Perth: collaborator
• Hospital das Clínicas de São Paulo - SP: collaborator
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Perth Children's Hospital

Perth, We, Australia

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Oxymetazoline; Saline Solution

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Britta S. von Ungern-Sternberg, MD PHD

CONTACT

+618 6456 4806; britta.regli-vonungern@health.wa.gov.au

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind trial
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, double-blinded randomised controlled trial

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: June 3, 2025
• Study Start: June 25, 2025
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): May 30, 2028
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)