Be Sweet to Babies During Nasolaryngoscopy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-23

Study Completion Date

2025-09-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Infant Conditions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sterile water

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

Group Type PLACEBO_COMPARATOR

Sterile water

Intervention Type OTHER

Participants will be given sterile water randomly

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.

Group Type EXPERIMENTAL

24% Sucrose

Intervention Type OTHER

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

Interventions

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24% Sucrose

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

Intervention Type OTHER

Sterile water

Participants will be given sterile water randomly

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No