Infant ConditionsNCT06641687
Be Sweet to Babies During Nasolaryngoscopy
A study testing 24% Sucrose and Sterile water in people with Infant Conditions, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Infant Conditions
- What is being tested?
- 24% Sucrose and Sterile water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2024to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mary-Elizabeth Vanderpost, RN contact
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1E8
Nikolaus E. Wolter, MD, 4168137654 ext. 204351, nikolaus.wolter@sickkids.ca
About this study
Official title: Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy
The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.
Read the 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.
- Conditions
- Infant Conditions
- Being tested
- 24% Sucrose, Sterile water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24% SucroseOther
Participants will be given either sugar water (24% sucrose) randomly
Sterile waterOther
Participants will be given sterile water randomly
| Study group | Role | What they receive |
|---|---|---|
| Sterile water | Placebo comparator | Participants will be given sterile water which does not contain sugar and is used as a placebo Receives: Other: Sterile water |
| Sucrose solution | Experimental | Participants will be given sugar water which contains 24% sucrose. As per pharmacy at The Hospital for Sick Children, Sucrose is not classified as a drug as per Health Canada. Receives: Other: 24% Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
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).
Measured: up to 7 months
Secondary outcomes (6)
Crying time
Crying time (second - s) after FNL in 60 infants under 12 months of age following the use of oral sucrose solutions.
Measured: up to 7 months
Maximum Heart rate
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.
Measured: up to 7 months
Time to baseline
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.
Measured: up to 7 months
Plantar skin conductance
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.
Measured: up to 7 months
Duration of clinic visit
Duration of clinic visits (minutes) following the administration of oral sucrose.
Measured: up to 7 months
Caregiver impression
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.
Measured: up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start23 Sep 2024
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ConditionsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaus Wolter, The Hospital for Sick Children
- Investigators
- Nikolaus E. Wolter, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06641687
- Sponsor's protocol ID
- 1000081486
- Status last verified
- Jul 2025
- First submitted
- 4 Oct 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We are not going to make individual patient data available to others.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy
- ClinicalTrials.gov ID
- NCT06641687
- Acronym / sponsor ID
- 1000081486
- Conditions
- Infant Conditions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 23 Sep 2024 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sterile water | Placebo comparator | Other: Sterile waterParticipants will be given sterile water which does not contain sugar and is used as a placebo |
| Sucrose solution | Experimental | Other: 24% SucroseParticipants will be given sugar water which contains 24% sucrose. As per pharmacy at The Hospital for Sick Children, Sucrose is not classified as a drug as per Health Canada. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 24% SucroseParticipants will be given either sugar water (24% sucrose) randomly | Other | Sucrose solution |
| Sterile waterParticipants will be given sterile water randomly | Other | Sterile water |
Primary outcome
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).
6 secondary outcomes
Crying time
Time frame: up to 7 months
Maximum Heart rate
Time frame: up to 7 months
Time to baseline
Time frame: up to 7 months
Plantar skin conductance
Time frame: up to 7 months
Duration of clinic visit
Time frame: up to 7 months
Caregiver impression
Time frame: up to 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Individual participant dataSharing planned: No. We are not going to make individual patient data available to others.
Related trials for Infant Conditions
Active, not recruiting
Providing an Optimized and Empowered Pregnancy for You (POPPY) Aim 3: Randomized Controlled Trial
Pregnancy Complications, Maternal Distress
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
RecruitingObservational study
Natural History of Noncirrhotic Portal Hypertension
Cystic Fibrosis, Immunologic Deficiency Syndrome
Recruiting
Sustained Cord Circulation at Emergency Cesarean Section
Asphyxia Neonatorum, Fetal Hypoxia
RecruitingObservational study
Hospital-Based Prospective Cohort of Malnutrition Under 6-Month Study (HOSPIC-6-Study)
Malnutrition, Infant, Malnutrition
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mary-Elizabeth Vanderpost, RN contact
Nikolaus E. Wolter, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24% Sucrose and Sterile water in people with Infant Conditions, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nikolaus E. Wolter, MD (4168137654 ext. 204351, nikolaus.wolter@sickkids.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: up to 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.