Clinical Trial

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

Study acronym: NARWHAL
Recruiting Phase 4
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-22.
Status change: Not Yet Recruiting → Recruiting 2025-11-17
Trial Details
NCT Number NCT07000877
Lead Sponsor Telethon Kids Institute
Collaborators: Child and Adolescent Health Service - Perth, University of Sao Paulo General Hospital, Rigshospitalet, Denmark
Conditions Perioperative Respiratory Adverse Events, Anesthesia Outcomes
Enrollment 200 participants
Start Date 2025-06-25
Primary Completion 2028-05-30 (estimated)
Study Completion 2028-05-30 (estimated)
Updated on ClinicalTrials.gov 2025-11-19