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

NCT07000877 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-19

No results posted yet for this study

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

Interventions

DRUG

Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))

Decongestant nasal spray containing active ingredient.

DRUG

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

Control nasal spray containing no active ingredient.

Sponsors & Collaborators

  • Child and Adolescent Health Service - Perth

    collaborator OTHER_GOV

  • Hospital das Clínicas de São Paulo - SP

    collaborator UNKNOWN

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Telethon Kids Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2028-05-30
Completion
2028-05-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07000877 on ClinicalTrials.gov