Be Sweet to Babies During Nasolaryngoscopy

The Hospital for Sick Children

Status: Enrolling

Conditions: Infant Conditions

Treatments: Other: Sterile water; Other: 24% Sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT06641687

1000081486

Details and patient eligibility

About

The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.

Full description

This study aims to evaluate the impact of oral sucrose on pain or distress in outpatient infants undergoing flexible nasolaryngoscopy during a scheduled appointment at the SickKids Pediatric Otolaryngology Clinic.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 12 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient <12 months of age;
• Scheduled for an appointment with Dr. Nikolaus Wolter or Dr. Jennifer Siu, who are Staff Pediatric Otolaryngologists at the Hospital for Sick Children, or Meghan Tepsich, a complex airway Nurse Practitioner at SickKids;
• Requiring flexible nasolaryngoscopy for diagnostic purposes;
• Accompanied by caregivers who provided consent.

Exclusion criteria

• Patient >12 months of age

• Infants <37 weeks corrected gestational age

• Infants with decreased level of consciousness or delayed neuromuscular development with limited pain response

• Infants who have received acute/urgent /emergent airway assessment such as respiratory distress or a foreign body, etc.

• Infants who have received topical anesthesia (topical decongestant/anesthetic spray)

• Infants with the following conditions, where oral sucrose is contraindicated or ineffective:

  • Carbohydrate intolerance
  • Decreased level of consciousness or heavy sedation
  • Absent gag reflex
  • Non-functional gastrointestinal tract
  • History of aspiration, tracheoesophageal fistula
  • Necrotizing enterocolitis

• Infants whose parents did not consent to enrolling their child in the study, including randomization into either arm of the study due to preference for a given intervention

• Any other circumstance in which consent for participation in the study was not obtained prior to the scope

Infants will also be excluded from the study if they present with conditions in which FNL is contraindicated:

• Severe respiratory distress
• Post-palliative systemic artery to pulmonary artery shunt
• Single ventricle congenital heart disease

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Sterile water

Placebo Comparator group

Description:

Participants will be given sterile water which does not contain sugar and is used as a placebo

Treatment:

Other: Sterile water

Sucrose solution

Experimental group

Description:

Participants will be given sugar water which contains 24% sucrose. As per pharmacy at The Hospital for Sick Children, Sucrose is not classified as a drug as per Health Canada.

Treatment:

Other: 24% Sucrose