Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

Kent State University

Status: Completed

Conditions: Posttraumatic Stress Disorders

Treatments: Drug: Inderol (propranolol)

Study type: Interventional

Funder types: Other

Identifiers

NCT00597389

04-326

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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29 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

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).

Treatment:

Drug: Inderol (propranolol)

2

Placebo Comparator group

Description:

A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution)

Treatment:

Drug: Inderol (propranolol)