Be Sweet to Babies During Nasolaryngoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 24% Sucrose, Sterile water.
- Who it may be relevant to
- Registry conditions: Infant Conditions. Basic parameters: 1 months — 12 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy
Overview
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.
Interventions
- Other 24% Sucrose
Participants will be given either sugar water (24% sucrose) randomly - Other Sterile water
Participants will be given sterile water randomly
Primary outcome measures
- Pain Scores [Time frame: up to 7 months]
Secondary outcome measures (6)
- Crying time [Time frame: up to 7 months]
- Maximum Heart rate [Time frame: up to 7 months]
- Time to baseline [Time frame: up to 7 months]
- Plantar skin conductance [Time frame: up to 7 months]
- Duration of clinic visit [Time frame: up to 7 months]
- Caregiver impression [Time frame: up to 7 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Supportive care
Study locations
Canada · 1 center
- The Hospital for Sick Children — Toronto
Identifiers
NCT: NCT06641687 · 1000081486