Infant Conditions
Conditions
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.
Interventions
OTHER24% Sucrose
Participants will be given either sugar water (24% sucrose) randomly
OTHERSterile water
Participants will be given sterile water randomly
Sponsors
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Months to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores | up to 7 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Heart rate | up to 7 months | Maximum heart rate (beats per minute - bpm) as measured by a pulse oximeter during FNL in 60 infants under 12 months of age following the use of oral sucrose solutions. |
| Time to baseline | up to 7 months | The time taken for heart rate to return to baseline (second - s) as measured by a pulse oximeter during FNL in 60 infants under 12 months of age following the use of oral sucrose solutions. |
| Crying time | up to 7 months | Crying time (second - s) after FNL in 60 infants under 12 months of age following the use of oral sucrose solutions. |
| Duration of clinic visit | up to 7 months | Duration of clinic visits (minutes) following the administration of oral sucrose. |
| Caregiver impression | up to 7 months | Caregiver impression of infant discomfort following the use of oral sucrose based on Wong-Baker FACES Pain Rating Scale (range of 0-10), higher scores mean a worse outcome. |
| Plantar skin conductance | up to 7 months | Plantar skin conductance (μS) during FNL in 60 infants under 12 months of age as measured by maximum peaks per second, following the use of oral sucrose solutions. |
Countries
Canada
Contacts
Primary ContactNikolaus E. Wolter, MD
Backup ContactMary-Elizabeth Vanderpost, RN
Outcome results
None listed