Be Sweet to Babies During Nasolaryngoscopy

NCT06641687 | Recruiting

• 1 other identifier: 1000081486
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Infant Conditions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Crying time

  up to 7 months

• Maximum Heart rate

  up to 7 months

• Time to baseline

  up to 7 months

• Plantar skin conductance

  up to 7 months

• Duration of clinic visit

  up to 7 months

Study Arms (2)

Sterile water

PLACEBO COMPARATOR

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

Other: Sterile water

Sucrose solution

EXPERIMENTAL

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

Interventions

24% Sucrose OTHER

Participants will be given either sugar water (24% sucrose) randomly

Sucrose solution

Sterile water OTHER

Participants will be given sterile water randomly

Sterile water

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

RECRUITING

MeSH Terms

Interventions

Sucrose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Nikolaus E. Wolter, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolaus E. Wolter, MD

CONTACT

4168137654; nikolaus.wolter@sickkids.ca

Mary-Elizabeth Vanderpost, RN

CONTACT

mary-elizabeth.vanderpost@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Otolaryngologist, Department of Otolaryngology - Head & Neck Surgery

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 15, 2024
• Study Start: September 23, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)