Be Sweet to Babies During Nasolaryngoscopy (NCT06641687) | Clinical Trial Compass
RecruitingNot Applicable
Be Sweet to Babies During Nasolaryngoscopy
Canada60 participantsStarted 2024-09-23
Plain-language summary
The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.
Who can participate
Age range
1 Month – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 whi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.