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Recruiting

NCT Number: NCT06641687

Be Sweet to Babies During Nasolaryngoscopy

The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.

Recruiting

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Key information

Conditions

Infant Conditions

Age range

1 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1E8, Canada

Location status: Recruiting

Location contact

Nikolaus E. Wolter, MD

CONTACT

[email protected]

4168137654 ext. 204351

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 which FNL is contraindicated:

  • Severe respiratory distress
  • Post-palliative systemic artery to pulmonary artery shunt
  • Single ventricle congenital heart disease

Treatment and study plan

24% Sucrose

Other

Participants will be given either sugar water (24% sucrose) randomly

Sterile Water

Other

Participants will be given sterile water randomly

Primary outcomes

  1. 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).

Secondary outcomes

  1. Crying time

    Time frame: up to 7 months

    Crying time (second - s) after FNL in 60 infants under 12 months of age following the use of oral sucrose solutions.

  2. Maximum Heart rate

    Time frame: up to 7 months

    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.

  3. Time to baseline

    Time frame: up to 7 months

    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.

  4. Plantar skin conductance

    Time frame: up to 7 months

    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.

  5. Duration of clinic visit

    Time frame: up to 7 months

    Duration of clinic visits (minutes) following the administration of oral sucrose.

  6. Caregiver impression

    Time frame: up to 7 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary-Elizabeth Vanderpost, RN

CONTACT

[email protected]

Nikolaus E. Wolter, MD

CONTACT

[email protected]

4168137654 ext. 204351

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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