Be Sweet to Babies During Nasolaryngoscopy

Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy

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

Study Overview

• Status: Recruiting
• Conditions: Infant Conditions
• Intervention / Treatment: Other: Sterile water; Other: 24% Sucrose

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nikolaus E. Wolter, MD; Phone Number: 204351 4168137654; Email: nikolaus.wolter@sickkids.ca
• Study Contact Backup: Name: Mary-Elizabeth Vanderpost, RN; Email: mary-elizabeth.vanderpost@sickkids.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1E8
      • Recruiting
      • The Hospital for Sick Children
      • Contact: Nikolaus E. Wolter, MD; Phone Number: 204351 4168137654; Email: nikolaus.wolter@sickkids.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sterile water; Participants will be given sterile water which does not contain sugar and is used as a placebo	Other: Sterile water; Participants will be given sterile water randomly
Experimental: Sucrose solution; 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.	Other: 24% Sucrose; Participants will be given either sugar water (24% sucrose) randomly

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Scores	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).	up to 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Crying time	Crying time (second - s) after FNL in 60 infants under 12 months of age following the use of oral sucrose solutions.	up to 7 months
Maximum Heart rate	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.	up to 7 months
Time to baseline	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.	up to 7 months
Plantar skin conductance	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.	up to 7 months
Duration of clinic visit	Duration of clinic visits (minutes) following the administration of oral sucrose.	up to 7 months
Caregiver impression	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.	up to 7 months

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Nikolaus E. Wolter, MD, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 11, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1000081486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are not going to make individual patient data available to others.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No