Propranolol Administration and Prevention of Child PTSD in Child Trauma Victims

NCT ID: NCT00597389

Last Updated: 2008-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-02-28

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Inderol (propranolol)

Intervention Type: 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.

2

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

Group Type: PLACEBO_COMPARATOR

Inderol (propranolol)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

propranolol

Eligibility 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

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Akron Children's Hospital

OTHER

Sponsor Role: collaborator

Ohio Board of Regents

UNKNOWN

Sponsor Role: collaborator

Kent State University

OTHER

Sponsor Role: lead

Responsible Party

Kent State University

Principal Investigators

Douglas L Delahanty, PhD

Role: PRINCIPAL_INVESTIGATOR

Kent State University

References

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.

Reference Type: RESULT

Other Identifiers

04-326

Identifier Type: -

Identifier Source: org_study_id