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The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sterile water | Placebo Comparator | Participants will be given sterile water which does not contain sugar and is used as a placebo |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 24% Sucrose | Other | Participants will be given either sugar water (24% sucrose) randomly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 7 months |
| Measure | Description | Time Frame |
|---|---|---|
| Crying time | Crying time (second - s) after FNL in 60 infants under 12 months of age following the use of oral sucrose solutions. | 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. |
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Inclusion Criteria:
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nikolaus E. Wolter, MD | Contact | 4168137654 | 204351 | nikolaus.wolter@sickkids.ca |
| Mary-Elizabeth Vanderpost, RN | Contact | mary-elizabeth.vanderpost@sickkids.ca |
| Name | Affiliation | Role |
|---|---|---|
| Nikolaus E. Wolter, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Recruiting | Toronto | Ontario | M5G 1E8 | Canada |
We are not going to make individual patient data available to others.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2024 | Oct 4, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Sterile water | Other | Participants will be given sterile water randomly |
|
| 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. | 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. | up to 7 months |
| Duration of clinic visit | Duration of clinic visits (minutes) following the administration of oral sucrose. | 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. | up to 7 months |
| D000073893 |
| Sugars |