Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

Kent State University29 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Posttraumatic Stress Disorders

Interventions

Inderol (propranolol)DRUG

Children ingested a propranolol HCL 20 mg/5 ml solution twice daily for 10 days (and taper for 5 days). Medication was initiated within 12 hours post-trauma. Dose was calculated to be 2.5 mg/kg/d with a maximum dose of 40 mg.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Medication-specific exclusion criteria included hypersensitivity to beta-blockers * Bradycardia * Cardiogenic or hypovolemic shock * Diabetes * 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.

Outcomes

Primary Outcomes

PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)

Time frame: 6-week follow-up

Secondary Outcomes

cardiovascular reactivity during trauma description

Time frame: at 6-week follow-up

Data from ClinicalTrials.gov

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