Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims
Information source: Kent State University
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Posttraumatic Stress Disorders
Intervention: Inderol (propranolol) (Drug)
Sponsored by: Kent State University
Official(s) and/or principal investigator(s):
Douglas L Delahanty, PhD, Principal Investigator, Affiliation: Kent State University
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.
Official title: The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)
Secondary outcome: cardiovascular reactivity during trauma description
Minimum age: 10 Years.
Maximum age: 18 Years.
- 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.
- Medication-specific exclusion criteria included hypersensitivity to beta-blockers
- 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.
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Starting date: February 2004
Last updated: January 17, 2008