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临床试验/NCT02062996
NCT02062996撤回2 期

The Hemodynamic and Pharmacokinetic Analysis of Oxymetazoline Absorption During Functional Endoscopic or Turbinate Reduction Surgery and From the Nasal Mucosa During Operative Dentistry

Richard Cartabuke1 个研究点 分布在 1 个国家开始时间: 2014年6月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Full strength oxymetazoline pledgets packed in the nose (total volume 20 ml).

干预措施: Oxymetazoline (Drug)

ENT - 1/2 strength

Experimental

½ strength oxymetazoline pledgets packed in the nose (total volume 20 ml).

干预措施: Oxymetazoline (Drug)

DENTAL - Full strength 1.0 mL

Experimental

Full strength oxymetazoline 1.0 mL to each naris (total =1000 mcg).

干预措施: Oxymetazoline (Drug)

DENTAL - Full strength 0.5 mL

Experimental

Full strength oxymetazoline 0.5 mL to each naris (total = 500 mcg).

干预措施: Oxymetazoline (Drug)

DENTAL - ½ strength 0.5 mL

Experimental

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

发起方
Richard Cartabuke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Richard Cartabuke

Co-Director Outpatient Anesthesia Services

Nationwide Children's Hospital

研究点 (1)

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