RecruitingPhase 4NCT07000877

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

Nasal Decongestant Administration to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having General Anesthesia - a Low Risk Intervention. (NARWHAL)


Sponsor

Telethon Kids Institute

Enrollment

200 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 8 Years

Inclusion Criteria2

  • 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).

Exclusion Criteria9

  • 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).

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Interventions

DRUGDecongestant nasal spray (oxymetazoline hydrochloride (0.05%))

Decongestant nasal spray containing active ingredient.

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

Control nasal spray containing no active ingredient.


Locations(1)

Perth Children's Hospital

Perth, We, Australia

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NCT07000877


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