Intra-nasal Topical Local Anesthetic and Decongestant for Flexible Nasendoscopy in Children: a Randomised Double-blind Placebo Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Pain score (self)
研究概览
简要总结
Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in outpatients. The purpose of this randomized controlled double-blind study is to determine whether there is a difference in the degree of discomfort experienced by children undergoing flexible nasendoscopy, after receiving one of three different intranasal sprays: (A) placebo (isotonic saline solution), (B) decongestant (0.05% xylometazoline hydrochloride), or (C) decongestant with local anesthetic (0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride).
Null hypothesis: There is no difference in the degree of reported discomfort experienced (using a validated pediatric pain score) by children undergoing flexible nasendoscopy, after receiving either intra-nasal topical placebo, decongestant, or decongestant with local anesthetic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully informed consent from parent/caregiver
- •Children aged 3 to 12 years
- •Children deemed to require flexible nasendoscopy as part of their assessment during a Pediatric Otolaryngology clinic visit
排除标准
- •Children who have previously undergone this procedure
- •Children with current upper respiratory tract infection
- •Children with known allergy to any of the trial medications
研究组 & 干预措施
Saline spray
干预措施: Isotonic normal saline (Drug)
Decongestant
干预措施: 0.05% xylometazoline hydrochloride (Drug)
Decongestant and local anesthetic
干预措施: 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride (Drug)
结局指标
主要结局
Pain score (self)
时间窗: Immediately post-nasendoscopy - same day as administration of nasal prep agent (day 1)
Self-reported Wong-Baker Faces Pain Score
次要结局
- Pain score (proxy)(Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1))
- Ease of nasendoscopy score(Immediately post-nasendoscopy- same day as administration of nasal prep agent (day 1))
研究者
Neil Chadha
Clinical Assistant Professor
Children's & Women's Health Centre of British Columbia