The Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery and From the Nasal Mucosa During Operative Dentistry
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Oxymetazoline plasma concentration
研究概览
简要总结
Oxymetazoline is an α-adrenergic agonist that is commonly used as a topical sympathomimetic agent in over-the-counter decongestant sprays. It is used extensively at Nationwide Children's Hospital for surgical procedures to produce vasoconstriction and reduce bleeding. Although there is generally limited vascular absorption, when administered in larger doses, uptake of oxymetazoline can lead to significant systemic hemodynamic effects. The NCH anesthesia department recently reported a case of oxymetazoline induced postoperative hypertension in a three-year-old child following inferior turbinate reduction and adenoidectomy. Current practice at NCH is to soak pledgets with full strength oxymetazoline and insert a varying number of pledgets during surgical procedures or instill oxymetazoline drops into the nose prior to nasotracheal intubation. There is no pediatric data regarding the method of administration and the absorption of oxymetazoline or the dose-response relationship of oxymetazoline serum levels on blood pressure and heart rate. These studies would be the first to determine safe and appropriate doses of oxymetazoline in the pediatric population.
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
- None
入排标准
- 年龄范围
- 2 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 2 through 12 yrs.
- •Scheduled for: operative dentistry, functional endoscopic sinus surgery, or turbinate reduction (with or without tonsillectomy and/or adenoidectomy).
排除标准
- •Treatment with oral decongestants or antihistamines within 24 hours of surgery.
- •Taking anticoagulants.
- •History of nasal trauma.
- •History of epistaxis (nose bleeds).
- •History of hypertension or cardiac disease.
- •Allergy to oxymetazoline.
研究组 & 干预措施
ENT - full strength
Full strength oxymetazoline pledgets packed in the nose (total volume 20 ml).
干预措施: Oxymetazoline (Drug)
ENT - 1/2 strength
½ strength oxymetazoline pledgets packed in the nose (total volume 20 ml).
干预措施: Oxymetazoline (Drug)
DENTAL - Full strength 1.0 mL
Full strength oxymetazoline 1.0 mL to each naris (total =1000 mcg).
干预措施: Oxymetazoline (Drug)
DENTAL - Full strength 0.5 mL
Full strength oxymetazoline 0.5 mL to each naris (total = 500 mcg).
干预措施: Oxymetazoline (Drug)
DENTAL - ½ strength 0.5 mL
½ strength oxymetazoline 0.5 mL to each naris (total = 250 mcg).
干预措施: Oxymetazoline (Drug)
结局指标
主要结局
Oxymetazoline plasma concentration
时间窗: 5, 10, 20, 45, 90 & 150 mins. after dosing
次要结局
- Heart rate(Every 2-5 mins. for a maximum of 240 mins.)
- Blood pressure(Every 2-5 mins. for a maximum of 240 mins.)
研究者
Richard Cartabuke
Co-Director Outpatient Anesthesia Services
Nationwide Children's Hospital
