Testing 24% Sucrose with Sterile water against a placebo for infant conditions
Official title: Be Sweet to Babies During Nasolaryngoscopy
Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy
- 2 groups
- One site, in Toronto
- Recruiting
Interventions
- Other intervention
24% Sucrose
Participants will be given either sugar water (24% sucrose) randomly
- Other intervention
Sterile water
Participants will be given sterile water randomly
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario
Eligibility Criteria
See who this study is looking for22 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
Exclusion
- −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 consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → to enrolling their child in the study, including randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → into either armArmOne of the groups in a study, each receiving something different.Read more → 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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to improve comfort and quality of life alongside other care.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Sterile water.
Registry label: A: Sterile water
Group B receives 24% Sucrose.
Registry label: B: Sucrose solution
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 1 month to 12 months.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 60 people.
The study is currently expected to finish around September 2025.
The main measurement is taken over: up to 7 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Pain Scores — measured over up to 7 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06641687 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 24% SucroseOther
Participants will be given either sugar water (24% sucrose) randomly
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Sterile waterOther
Participants will be given sterile water randomly
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 1 month to 12 months.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 1 month to 12 months.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: up to 7 months.
The study as a whole is currently expected to finish around 2025-09-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 60 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Toronto, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.
Think this trial might be right for you?
Complete a quick intake form and we will match you with this and other relevant trials based on your medical profile.
See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.