Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Compare changes in self-reported ear pain during hyperbaric oxygen therapy
研究概览
简要总结
The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT. Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure.
详细描述
Subjects will be asked to take a pill (pseudoephedrine or placebo) between 45 and 120 minutes before hyperbaric oxygen therapy. Subjects' ears will be examined before and after therapy and be asked to assess ear pain. There will be no further tests or procedures after completion of therapy session and ear examinations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
double-blind placebo control
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New patient requiring HBOT (either inpatient or outpatient)
- •Age greater than or equal to 18 years and less than 80 years
- •Fluent in English
- •Full decision capacity
- •Able and medically cleared to swallow a pill
排除标准
- •Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)
- •Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)
- •Systolic Blood Pressure >160
- •Diastolic Blood Pressure > 90
- •Heart Rate >100
- •Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
- •Intubated
- •Unable to swallow oral medications
研究组 & 干预措施
Pseudoephedrine
over the counter pseudoephedrine
干预措施: Pseudoephedrine Pill (Drug)
Placebo
pharmacy created placebo capsule
干预措施: Placebo (Drug)
结局指标
主要结局
Compare changes in self-reported ear pain during hyperbaric oxygen therapy
时间窗: 45-60 minutes
Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy
次要结局
- Incidence of completed compression(1 minute)
研究者
Jacinta Showers
Principal Investigator
John Muir Health