Official Title: “The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.”

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

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2005

Intervention(s) in this Clinical Trial

• Drug: Inderol (propranolol)
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 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).
• Placebo Comparator: 2
  • A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution)

Primary Measures

• PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)
  • Time Frame: 6-week follow-up
    Safety Issue?: No

Secondary Measures

• cardiovascular reactivity during trauma description
  • Time Frame: at 6-week follow-up
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kent State University

Overall Clinical Trial Officials and Contacts

Douglas L Delahanty, PhD Principal Investigator Kent State University  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00597389

Study ID Number: 04-326

ClinicalTrials.gov Identifier: NCT00597389

Health Authority: United States: Institutional Review Board