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CompletedNCT00597389Updated Jan 18, 2008

Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

An interventional study of Inderol (propranolol) in Posttraumatic Stress Disorders, sponsored by Kent State University. Completed. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2008-01-18.

Sponsored by Kent State University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
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Study 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.

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Conditions studied

  • Posttraumatic Stress Disorders

Keywords

  • posttraumatic stress disorder
  • propranolol
  • inderol
  • child
  • trauma
  • Posttraumatic stress disorders (PTSD)
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In context

Stress Disorders, Traumatic

1,147 studies on the registry are indexed under Stress Disorders, Traumatic; 108 are open to participants now.

This study's enrollment of 29 is below the median of 60 across 908 interventional studies indexed under Stress Disorders, Traumatic.

Browse Stress Disorders, Traumatic studies →

Lead sponsor

Kent State University is the lead sponsor of 31 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts 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

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Active comparator
    1

    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)

  • Placebo comparator
    2

    A 25/5ml solution of placebo (a sugar solution that looks and tastes like the propranolol solution)

    Drug: Inderol (propranolol)

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.

    Also known as: propranolol

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What researchers measure

Primary outcomes

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

    Time frame: 6-week follow-up

Secondary outcomes

  1. cardiovascular reactivity during trauma description

    Time frame: at 6-week follow-up

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Study locations

No study locations are listed for this record.

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References and documents

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.
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00597389
Lead sponsor
Kent State University
Collaborators
Akron Children's Hospital, Ohio Board of Regents
First posted
Jan 18, 2008
Start date
Feb 2004
Primary completion
Nov 2005
Completion
Feb 2006
Last update
Jan 18, 2008

Study contacts

Douglas L Delahanty, PhD
principal investigator · Kent State University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2008. You cannot join it, but the record below documents what was studied.

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