Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

Posttraumatic Stress Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00597389
• Other study ID #: 04-326
• Status: Completed
• Phase: N/A
• First received: January 9, 2008
• Last updated: January 17, 2008
• Start date: February 2004
• Est. completion date: February 2006

Study information

• Verified date: January 2008
• Source: Kent State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 2006
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Posttraumatic Stress Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Kent State University	Akron Children's Hospital, Ohio Board of Regents

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PTSD symptoms with the Clinician Administered PTSD Scale for Children and Adolescents (CAPS-CA)		6-week follow-up	No
Secondary	cardiovascular reactivity during trauma description		at 6-week follow-up	No