The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 主要终点
- PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)
研究概览
简要总结
Twenty-nine pediatric injury patients (ages 10-18) at risk for PTSD were randomly assigned to receive either propranolol or placebo in a double-blind placebo controlled design. Medication was initiated within 12 hours of hospital admission. At 6-weeks, child PTSD symptoms and heart rate (HR) during trauma recall were assessed. We hypothesized that participants who received propranolol would report fewer PTSD symptoms and have lower heart rates than those who received placebo.
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)
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants consisted of 15 male and 14 female accidental injury patients aged 10-18 recruited from the emergency department of Akron Children's Hospital. - Eligibility criteria included a Glasgow Coma Scale (GCS) score of 14 or greater (to permit informed consent) and an "at-risk" child score on the STEPP (Winston, Kassam-Adams, Garcia-Espana, Ittenbach, & Cnaan, 2003), a screen for risk of PTSD.
排除标准
- •Medication-specific exclusion criteria included hypersensitivity to beta-blockers
- •Bradycardia
- •Cardiogenic or hypovolemic shock
- •Preexisting heart condition; OR
- •Treatment for asthma within the year prior to study entry (per Lacy, Armstrong, Goldman, & Lance, 2002).
- •Children were also excluded if they received epinephrine during emergency care or if they sustained any injuries precluding initiation of the propranolol regimen within 12 hours post-trauma.
研究组 & 干预措施
1
oral solution of propranolol (propranolol HCL 20 mg/5 ml solution) or a liquid placebo twice daily for 10 days (and taper for 5 days; based on Pitman et al, 2002). Dose was calculated as determined by Famularo et al. (1988) to be 2.5 mg/kg/d with a maximum dose of 40 mg bid (Green, 2001).
干预措施: Inderol (propranolol) (Drug)
2
A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution)
干预措施: Inderol (propranolol) (Drug)
结局指标
主要结局
PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)
时间窗: 6-week follow-up
次要结局
- cardiovascular reactivity during trauma description(at 6-week follow-up)