Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infant Conditions
- Sponsor
- The Hospital for Sick Children
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Pain Scores
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Nikolaus Wolter
Staff Otolaryngologist, Department of Otolaryngology - Head & Neck Surgery
The Hospital for Sick Children
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
Outcomes
Primary Outcomes
Pain Scores
Time Frame: 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 Outcomes
- Crying time(up to 7 months)
- Maximum Heart rate(up to 7 months)
- Time to baseline(up to 7 months)
- Plantar skin conductance(up to 7 months)
- Duration of clinic visit(up to 7 months)
- Caregiver impression(up to 7 months)