Nasal spray to reduce breathing problems around anesthesia in children with colds
Official title: Nasal Decongestant Administration to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having General Anesthesia - a Low Risk Intervention. (NARWHAL)
Run by Telethon Kids Institute · NCT07000877 · Data updated 2026-11-12
This trial tests whether a nasal decongestant spray given just before anesthesia can reduce breathing complications in children aged 1 to 8 with a recent upper respiratory infection who are having surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 8 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Telethon Kids Institute Academic / other |
| Locations | 1 site (Perth, We) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | May 30, 2028 |
| Study ends | May 30, 2028 |
| Registry record updated | November 19, 2025 |
| Trial ID | NCT07000877 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 1.0 to 8.99 years with a current or recent (<2 weeks) upper respiratory tract infection who are scheduled for elective or urgent general anesthesia and meet other trial criteria are ideal candidates.
✕Probably not a fit
Children with ASA III or higher, known significant cardiovascular/respiratory/neurological disease, thyroid disease or diabetes, those already using nasal decongestants, undergoing nasal surgeries, or requiring endotracheal tube/face mask/high-flow nasal oxygen are excluded and unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicentre, double-blind, randomized controlled trial enrolling 200 children aged 1 to 8 years with a current or recent (less than 2 weeks) upper respiratory tract infection who require general anesthesia. Participants are randomized at induction to receive either oxymetazoline 0.05% nasal spray or a placebo spray delivered with the same bottle/actuator. Perioperative respiratory adverse events (laryngospasm, bronchospasm, severe coughing, airway obstruction, oxygen desaturation <95%, and postoperative stridor) are monitored throughout the procedure and in the post-anesthesia care unit. The trial also records acceptability and ease of use for clinicians, children and parents.
Why it matters
Potential benefit: If successful, this simple, low-cost nasal spray could reduce the risk of serious breathing complications during emergence and recovery, making anesthesia safer for children with recent colds.
How similar studies have gone: Topical decongestants like oxymetazoline are well established for relieving nasal congestion, but randomized evidence specifically showing reduced perioperative respiratory adverse events in children is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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's running
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Perth Children's Hospital
Perth, We, Australia Recruiting
Study contacts
- Study coordinator: Britta S. von Ungern-Sternberg, MD PHD
- Email: britta.regli-vonungern@health.wa.gov.au
- Phone: +618 6456 4806
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.