Be Sweet to Babies During Nasolaryngoscopy

Not Applicable

Recruiting

• Conditions: Infant Conditions

• Registration Number: NCT06641687
• Lead Sponsor: The Hospital for Sick Children

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2024-09-23
• Status Verified: 2024-10
• Study First Submitted: 2024-10-04
• Study First Submitted QC: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Scores	up to 7 months	Clinical pain scores change after flexible nasolaryngoscopy (FNL) in 60 infants under 12 months of age following the use of sucrose solutions. The EVENDOL scale is a validated 15-point scale (range of 0-15) developed for children with presenting, prolonged, or procedural pain. Infant pain observations are ranked from 0-3 based on 5 different observations: (1) vocal or verbal expression, (2) facial expression, (3) movements, (4) postures, and (5) interactions with the environment. Higher scores mean a worse outcome (more pain).

Secondary Outcome Measures

Name	Time	Method
Crying time	up to 7 months	Crying time (second - s) after FNL in 60 infants under 12 months of age following the use of oral sucrose solutions.
Maximum Heart rate	up to 7 months	Maximum heart rate (beats per minute - bpm) as measured by a pulse oximeter during FNL in 60 infants under 12 months of age following the use of oral sucrose solutions.
Time to baseline	up to 7 months	The time taken for heart rate to return to baseline (second - s) as measured by a pulse oximeter during FNL in 60 infants under 12 months of age following the use of oral sucrose solutions.
Plantar skin conductance	up to 7 months	Plantar skin conductance (μS) during FNL in 60 infants under 12 months of age as measured by maximum peaks per second, following the use of oral sucrose solutions.
Duration of clinic visit	up to 7 months	Duration of clinic visits (minutes) following the administration of oral sucrose.
Caregiver impression	up to 7 months	Caregiver impression of infant discomfort following the use of oral sucrose based on Wong-Baker FACES Pain Rating Scale (range of 0-10), higher scores mean a worse outcome.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada