Perioperative Respiratory Adverse EventsPhase 4NARWHALNCT07000877
Nasal Decongestant to Reduce Perioperative Adverse Events in Children With Upper Respiratory Track Infections Having Anesthesia.
A Phase 4 study testing Decongestant nasal spray (oxymetazoline hydrochloride (0.05%)) in people with Perioperative Respiratory Adverse Events and Anesthesia Outcomes, run by Telethon Kids Institute at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 8 years
- Conditions the study is for
- Perioperative Respiratory Adverse Events, Anesthesia Outcomes
- What is being tested?
- Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Jun 2025to 30 May 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Perth Children's Hospital
Perth, We
Britta S von Ungern-Sternberg, MD PhD, +61864564805, Britta.Regli-VonUngern@health.wa.gov.au
Lliana B Slevin, BSC, +61426952977, lliana.slevin@thekids.org.au
About this study
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)
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:
Read more
- 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.
Read the detailed description
Upper respiratory tract infections (URTI), including COVID-19 infection and the common cold, are common and frequent in children who present for elective surgery. Children with URTI are at a two-to-three-fold increased risk of perioperative respiratory adverse events (PRAE). PRAE are among the most serious and impactful consequences of paediatric anesthesia, including cardio-respiratory arrest, and therefore present a significant challenge for the pediatric anesthetist.
This two-phase, multicentre, international, double-blinded, randomised controlled trial aims to improve the safety of children with upper respiratory tract infections undergoing anesthesia by investigating the use of a nasal spray pre-operatively to reduce respiratory complications. Following informed written parental consent, 200 pediatric patients aged 1 to 8 years, undergoing general anesthesia for any surgery with current or recent URTI will be randomised to receive at the induction of anesthesia either a decongestant nasal spray or a placebo spray using the same bottle/actuator.
Monitoring and recording of PRAE (laryngospasm - closure of the vocal cords, bronchospasm - narrowing of the airways, severe and persistent coughing, airway obstruction, oxygen desaturation (<95%) and postoperative stridor-squeaky noises when breathing) will occur throughout the procedure and in the post anesthesia care unit (PACU). We hypothesise that children who receive the nasal decongestant will be at a reduced risk of developing PRAE.
- Being tested
- Decongestant nasal spray (oxymetazoline hydrochloride (0.05%)), PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%
- Keywords
- perioperative respiratory adverse events, nasal decongestant, upper respiratory tract infection, Children, surgery, pediatrics, anesthesia
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))Drug
Decongestant nasal spray containing active ingredient.
PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%Drug
Control nasal spray containing no active ingredient.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Severe PRAE is defined as laryngospasm or bronchospasm, as assessed by the clinician caring for the patient.
Measured: 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.
Minor PRAE is defined as severe coughing, desaturation <95% for at least 10 seconds, airway obstruction, stridor or pulmonary aspiration, as assessed by the clinician caring for the patient.
Measured: 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
Children aged 4 and over and their parents/guardians will be asked to rate the acceptibility of the intervention using a 5-point Likert scale (1 = completely unacceptable; 5 = completely acceptable).
Measured: 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 acceptibility of the intervention on a 5-point Likert scale (1 = completely unacceptable; 5 = completely acceptable)
Measured: 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 recorded as per the study doctor and the clinical team caring for the patient.
Measured: Any potential adverse effects will be assessed from the administration of the interventional product until the patient's discharge from hospital.
Assessment of the successful administration of the interventional product in children
This will be based upon the clinical judgement of the treating anesthesia clinician.
Measured: Successful administration of the interventional product will be assessed by the study team at induction of anesthesia, immediately following the administration or attempted administration of the nasal decongestant or placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start25 Jun 2025
- Primary completion30 May 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perioperative Respiratory Adverse EventsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, double-blinded randomised controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Telethon Kids Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Child and Adolescent Health Service - Perth, University of Sao Paulo General Hospital, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000877
- Sponsor's protocol ID
- RGS0000007387
- Acronym
- NARWHAL
- Status last verified
- Sep 2025
- First submitted
- 13 May 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No