Recruiting

Sugar Water

Sponsor:

The Hospital for Sick Children

Code:

NCT06641687

Conditions

Infant Conditions

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

Interventions

24% Sucrose

Sterile water

Study Details

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

Study ID

NCT06641687

Start date

Sep 23, 2024

Status verified date

Jul, 2025

Completion date

Sep 1, 2025

Anticipated

Primary completion date

Sep 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 1

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

placebo comparator: Sterile water

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

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.

Interventions

24% Sucrose

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

Sterile water

Participants will be given sterile water randomly

Primary outcome measure

  • Pain Scores [ Time Frame: up to 7 months ]

Central Contacts and Locations

Central contacts

Nikolaus E. Wolter, MD

4168137654nikolaus.wolter@sickkids.ca

Mary-Elizabeth Vanderpost, RN

mary-elizabeth.vanderpost@sickkids.ca

Locations

The Hospital for Sick Children

Recruiting

Toronto, Ontario, Canada, M5G 1E8

Contacts

Nikolaus E. Wolter, MD

4168137654nikolaus.wolter@sickkids.ca

More Information

Sponsor

The Hospital for Sick Children

Last update posted

Jul 4, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Hospital for Sick Children on 2025-07-04.