Posttraumatic Stress Disorders Clinical Trial
Official title:
The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.
Verified date | January 2008 |
Source | Kent State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | February 2006 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 18 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Kent State University | Akron Children's Hospital, Ohio Board of Regents |
The efficacy of early propranolol administration at preventing/reducing PTSD symptoms in child trauma victims: Pilot. Nugent, Nicole Renee; Dissertation Abstracts International: Section B: The Sciences and Engineering, Vol 68(4-B), 2007. pp. 2665.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA) | 6-week follow-up | No | |
Secondary | cardiovascular reactivity during trauma description | at 6-week follow-up | No |
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