Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

Study Overview
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Brief Summary
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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
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The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.

Conditions
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Posttraumatic Stress Disorders

Intervention / Treatment
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* Drug: Inderol (propranolol)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>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). | Drug: Inderol (propranolol)<br>* 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.<br>* Other names: propranolol;|
| Placebo Comparator: 2<br>A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution) | Drug: Inderol (propranolol)<br>* 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.<br>* Other names: propranolol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA) |  | 6-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular reactivity during trauma description |  | at 6-week follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posttraumatic stress disorder, propranolol, inderol, child, trauma, Posttraumatic stress disorders (PTSD)