NCT00597389

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2004

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
Last Updated

January 18, 2008

Status Verified

January 1, 2008

Enrollment Period

1.8 years

First QC Date

January 9, 2008

Last Update Submit

January 17, 2008

Conditions

Posttraumatic Stress Disorders

Keywords

posttraumatic stress disorderpropranololinderolchildtraumaPosttraumatic stress disorders (PTSD)

Outcome Measures

Primary Outcomes (1)

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

    6-week follow-up

Secondary Outcomes (1)

  • cardiovascular reactivity during trauma description

    at 6-week follow-up

Study Arms (2)

1

ACTIVE COMPARATOR

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).

Drug: Inderol (propranolol)

2

PLACEBO COMPARATOR

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

Drug: Inderol (propranolol)

Interventions

Inderol (propranolol)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.

Also known as: propranolol
12

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    RESULT

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticWounds and Injuries

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Douglas L Delahanty, PhD

    Kent State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

February 1, 2004

Primary Completion

November 1, 2005

Study Completion

February 1, 2006

Last Updated

January 18, 2008

Record last verified: 2008-01