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Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims
This study has been completed.
Study NCT00597389   Information provided by Kent State University
First Received: January 9, 2008   Last Updated: January 17, 2008   History of Changes

January 9, 2008
January 17, 2008
February 2004
November 2005   (final data collection date for primary outcome measure)
PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA) [ Time Frame: 6-week follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00597389 on ClinicalTrials.gov Archive Site
cardiovascular reactivity during trauma description [ Time Frame: at 6-week follow-up ] [ Designated as safety issue: No ]
Same as current
 
Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims
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.

 
 
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Posttraumatic Stress Disorders
Drug: Inderol (propranolol)
  • Active Comparator: 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: A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
29
February 2006
November 2005   (final data collection date for primary outcome measure)

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.
Both
10 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00597389
Douglas L. Delahanty/ Professor, Kent State University
04-326
Kent State University
  • Akron Children's Hospital
  • Ohio Board of Regents
Principal Investigator: Douglas L Delahanty, PhD Kent State University
Kent State University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP