Actively Recruiting
Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy in Infants
Led by The Hospital for Sick Children · Updated on 2025-07-04
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether oral sucrose (sugar water containing 24% sucrose) can reduce pain and distress in infants undergoing flexible nasolaryngoscopy, a procedure used to examine the nasal and throat areas. This study takes place in an outpatient setting at the SickKids Pediatric Otolaryngology Clinic and aims to understand how sucrose affects pain scores and other measures in babies during this procedure. Participants will be randomly assigned to receive either sterile water without sugar (placebo) or sugar water with 24% sucrose before the nasolaryngoscopy. The sucrose solution is not classified as a drug by Health Canada. The study uses a quadruple masking method, meaning that participants, caregivers, and researchers do not know which solution is given. This helps compare the effects of the sugar water to sterile water more accurately. During the study visit, researchers will measure pain scores, crying time, heart rate, time to baseline, skin conductance, visit duration, and caregiver impressions in infants up to 7 months old. Caregivers provide consent, and infants are monitored closely during and after the procedure to assess these outcomes. The total participation spans the scheduled clinic appointment when the flexible nasolaryngoscopy is performed.
CONDITIONS
Brief Title
Be Sweet to Babies During Nasolaryngoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient less than 12 months of age
- Scheduled for an appointment with specific pediatric otolaryngologists or a complex airway nurse practitioner at the Hospital for Sick Children
- Requiring flexible nasolaryngoscopy for diagnostic purposes
- Accompanied by caregivers who provided consent
You will not qualify if you...
- Patient older than 12 months of age
- Infants younger than 37 weeks corrected gestational age
- Infants with decreased consciousness or delayed neuromuscular development limiting pain response
- Infants who had urgent airway assessments such as for respiratory distress or foreign body
- Infants who received topical anesthesia (decongestant or anesthetic spray)
- Infants with conditions contraindicating oral sucrose, including carbohydrate intolerance, absent gag reflex, non-functional gastrointestinal tract, history of aspiration or tracheoesophageal fistula, and necrotizing enterocolitis
- Infants without parental consent or who declined randomization
- Infants with severe respiratory distress
- Infants with post-palliative systemic artery to pulmonary artery shunt
- Infants with single ventricle congenital heart disease
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) during a scheduled appointment
Duration - 1 day (during the scheduled clinic visit)
Participants receive either oral sucrose (24% sugar water) or sterile water as a placebo during flexible nasolaryngoscopy to manage pain and distress.
1 visit (in-person) during a scheduled appointment
Duration - Up to 7 months
Participants are observed for pain scores, crying time, heart rate, and other outcomes for up to 7 months after the procedure.
Follow-up assessments may occur during or after clinic visits up to 7 months
Trial Site Locations
Total: 1 location
1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1E8
Actively Recruiting
Research Team
N
Nikolaus E. Wolter, MD
M
Mary-Elizabeth Vanderpost, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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