Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims - Full Text View

Sponsor:	Kent State University
Collaborators:	Akron Children's Hospital Ohio Board of Regents
Information provided by:	Kent State University
ClinicalTrials.gov Identifier:	NCT00597389

Purpose

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.

Condition	Intervention
Posttraumatic Stress Disorders	Drug: Inderol (propranolol)

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.

Resource links provided by NLM:

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Wounds

Drug Information available for: Propranolol hydrochloride Propranolol Dexpropranolol

U.S. FDA Resources

Further study details as provided by Kent State University:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

cardiovascular reactivity during trauma description [ Time Frame: at 6-week follow-up ] [ Designated as safety issue: No ]

Enrollment:	29
Study Start Date:	February 2004
Study Completion Date:	February 2006
Primary Completion Date:	November 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: 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).	Drug: Inderol (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.
2: Placebo Comparator A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution)	Drug: Inderol (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.

Eligibility

Ages Eligible for Study:	10 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597389

Sponsors and Collaborators

Kent State University

Akron Children's Hospital

Ohio Board of Regents

Investigators

Principal Investigator:

Douglas L Delahanty, PhD

Kent State University

More Information

Publications:

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.

Responsible Party:	Kent State University ( Douglas L. Delahanty/ Professor )
Study ID Numbers:	04-326
Study First Received:	January 9, 2008
Last Updated:	January 17, 2008
ClinicalTrials.gov Identifier:	NCT00597389 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Kent State University:

posttraumatic stress disorder
propranolol
inderol

child
trauma
Posttraumatic stress disorders (PTSD)

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Stress Disorders, Traumatic
Pharmacologic Actions

Pathologic Processes
Anxiety Disorders
Propranolol
Mental Disorders
Therapeutic Uses
Stress Disorders, Post-Traumatic
Adrenergic beta-Antagonists
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on November 27, 2009