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Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

Information source: Kent State University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Posttraumatic Stress Disorders

Intervention: Inderol (propranolol) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Kent State University

Official(s) and/or principal investigator(s):
Douglas L Delahanty, PhD, Principal Investigator, Affiliation: Kent State University

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.

Clinical Details

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

Study design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

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

Secondary outcome: cardiovascular reactivity during trauma description

Eligibility

Minimum age: 10 Years. Maximum age: 18 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: February 2004
Ending date: February 2006
Last updated: January 17, 2008

Page last updated: June 20, 2008

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