Posttraumatic Stress Disorders
Conditions
Keywords
posttraumatic stress disorder, propranolol, inderol, child, trauma, Posttraumatic stress disorders (PTSD)
Brief summary
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.
Interventions
DRUGInderol (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.
Sponsors
Akron Children's Hospital
Ohio Board of Regents
Kent State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA) | 6-week follow-up |
Secondary
| Measure | Time frame |
|---|---|
| cardiovascular reactivity during trauma description | at 6-week follow-up |
Outcome results
None listed