Be Sweet to Babies During Nasolaryngoscopy
ConditionInfant Conditions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-12
SponsorThe Hospital for Sick Children
About this trial
The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
24% Sucrose
Other interventionParticipants will be given either sugar water (24% sucrose) randomly
Sterile water
Other interventionParticipants will be given sterile water randomly
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Sterile waterPlacebo comparator 1 intervention
Group B: Sucrose solutionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
up to 7 monthsSecondary outcomes
1
Crying time
Crying time (second - s) after FNL in 60 infants under 12 months of age following the use of oral sucrose solutions.
Time frame
up to 7 months2
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.
Time frame
up to 7 months3
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.
Time frame
up to 7 months4
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.
Time frame
up to 7 monthsSponsors and contacts
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Source ClinicalTrials.gov