NCT00934947已完成2 期
The BURN HELP Trial: BURN Healing and AnaLgesia With Propranolol
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Overall Pain Trajectory Slopes
研究概览
简要总结
The purpose of this study is to investigate the ability of propranolol to decrease pain and improve recovery in burn patients with a common genotype.
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
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Thermal burn
- •Greater than or equal to 18 years of age
- •Less than 60 years of age
- •Able to speak and read English
排除标准
- •Intubated
- •Clinically unstable
- •Other substantial comorbid injury (e.g. long bone fracture)
- •Heart block greater than first degree (EKG)
- •History of coronary artery disease
- •History of congestive heart failure
- •Asthma (within past 10 years, induced by a beta-blocker, or receiving current treatment)
- •Psychotic, suicidal, or homicidal
- •Hepatic failure (acute or chronic)
- •Renal failure (acute or chronic)
- •History of hyperthyroidism unless taking synthroid or other thyroid hormone replacement
- •Exceeds daily acceptable chronic opioid use prior to burn
- •Interacting medication
- •Received propranolol within the last 6 months
- •Multiple severe allergic reactions
- •On daily methylphenidate or similar stimulant medication
- •Unwilling to use medically acceptable birth control (if childbearing potential)
- •Breastfeeding
- •Severe peripheral vascular disease or vasospastic disorder
- •Bradycardia that in the opinion of the investigator would constitute too great a risk when considered in the context of the patient's medical comorbidities and health history
- •Other criteria that in investigator's opinion makes participant poor candidate for the trial
- •Cancer (except basal cell cancer)
研究组 & 干预措施
Sugar pill
Placebo Comparator
干预措施: Placebo (Drug)
Propranolol, Propanolol ER
Experimental
干预措施: Propranolol (Drug)
Propranolol, Propanolol ER
Experimental
干预措施: Propanolol (Drug)
结局指标
主要结局
Overall Pain Trajectory Slopes
时间窗: Study days 5, 7, 10, 13, 17 and 19
Overall pain trajectory slopes by treatment group, where linear mixed modeling was used to combine pain measurements (waking, worst, and least pain) assessed on primary outcome days into an overall pain score. Pain was assessed using a 0-10 numeric rating scale (NRS). A lower score on the NRS indicated less pain and a higher score was indicative of worse pain.
次要结局
- Sleep Quality(6 weeks after injury timepoint was chosen for this analysis)
- Itch Symptoms(Week 6 after injury was chosen as the main timepoint of interest)
- Anxiety Symptoms(6 weeks after injury was chosen as the main timepoint of interest)
研究者
研究点 (4)
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