Oral Sucrose for Pain Management During Flexible Nasolaryngoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain Scores
研究概览
简要总结
The investigators want to know if sugar water containing 24% sucrose is helpful in reducing pain in babies during scopes.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Pain Scores
时间窗: 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).
次要结局
- Crying time(up to 7 months)
- Maximum Heart rate(up to 7 months)
- Time to baseline(up to 7 months)
- Plantar skin conductance(up to 7 months)
- Duration of clinic visit(up to 7 months)
- Caregiver impression(up to 7 months)
研究者
Nikolaus Wolter
Staff Otolaryngologist, Department of Otolaryngology - Head & Neck Surgery
The Hospital for Sick Children