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Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

NCT00597389 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2008-01-18

No results posted yet for this 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.

Conditions

  • Posttraumatic Stress Disorders

Interventions

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.

Sponsors & Collaborators

  • Akron Children's Hospital

    collaborator OTHER

  • Ohio Board of Regents

    collaborator UNKNOWN

  • Kent State University

    lead OTHER

Principal Investigators

  • Douglas L Delahanty, PhD · Kent State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2005-11-30
Completion
2006-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597389 on ClinicalTrials.gov