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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00597389
Other study ID # 04-326
Secondary ID
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


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
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