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

Telethon Kids Institute

Status and phase: Enrolling; Phase 4

Conditions: Perioperative Respiratory Adverse Events; Anesthesia Outcomes

Treatments: Drug: Decongestant nasal spray (oxymetazoline hydrochloride (0.05%)); Drug: PLACEBO: 2.5mL of normal saline 0.9% and benzalkonium chloride 0.02%

Study type: Interventional

Funder types: Other

Identifiers

NCT07000877

RGS0000007387

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 to 8 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

Decongestant nasal spray (oxymetazoline hydrochloride 0.05%)

Active Comparator group

Description:

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.

Treatment:

Drug: Decongestant nasal spray (oxymetazoline hydrochloride (0.05%))

Placebo Comparator : Placebo spray (control group)

Placebo Comparator group

Description:

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.

Treatment:

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