Clinical trial NCT06641687: Be Sweet to Babies During Nasolaryngoscopy
Official title: Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Conditions
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Pain Scores
timeFrame: up to 7 months
Secondary outcomes:
measure: Crying time
timeFrame: up to 7 months
measure: Maximum Heart rate
timeFrame: up to 7 months
measure: Time to baseline
timeFrame: up to 7 months
measure: Plantar skin conductance
timeFrame: up to 7 months
measure: Duration of clinic visit
timeFrame: up to 7 months
measure: Caregiver impression
timeFrame: up to 7 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Nikolaus E. Wolter, MD
role: PRINCIPAL_INVESTIGATOR
References: