Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

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.

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Key information

Conditions

Posttraumatic Stress Disorders Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Inderol (propranolol)

Drug

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.

Other names: propranolol

Primary outcomes

PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)

Time frame: 6-week follow-up

Secondary outcomes

cardiovascular reactivity during trauma description

Time frame: at 6-week follow-up

Sponsors and collaborators

Lead sponsor

Kent State University

Other

Collaborators

Akron Children's Hospital
Ohio Board of Regents

Registry information

Official study title

The Efficacy of Early Propranolol Administration at Preventing/Reducing PTSD Symptoms in Child Trauma Victims: Pilot.

Important dates

Study start: 2004
Primary completion: 2005
Study completion: 2006
First posted: Jan 18, 2008
Registry last updated: Jan 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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