TRAUMA HELP: Healing and Analgesia With Propranolol

Trauma Clinical Trial

— TRAUMA_HELP  

Official title:

Phase IIB Study: TRAUMA HELP: Healing and Analgesia With Propranolol

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01007084
• Other study ID #: 09-1391
• Status: Withdrawn
• Phase: Phase 2
• First received: November 2, 2009
• Last updated: December 7, 2011
• Start date: October 2009
• Est. completion date: July 2010

Study information

• Verified date: December 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether propranolol can decrease pain symptoms in a common subset of patients admitted to a trauma center after injury.

Description:

The main purpose of this pilot study is to investigate Propranolol's utility in the trauma population. Specifically, to see if it reduces pain scores post-injury.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• at least one fracture

• ages 18-60 yrs

• pain score >= 4

• speak and read English

Exclusion Criteria:

• gunshot, stab wound, or assault

• paraplegia/quadriplegia

• pregnancy

• psychotic, suicidal, or homicidal

• hepatic, kidney failure

• clinically unstable or intubated at time of recruitment

• hyperthyroidism

• propranolol use within the last 6 months

• significant bradycardia

• cancer (except basal cell)

• peripheral vascular disease

• heart block > 1 degree

• breastfeeding

• congestive heart failure

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Intervention

Drug:
• Propranolol
40 mg
• Propranolol ER
120 mg twice per day
• Sugar pills
sugar pill

Locations

Country	Name	City	State
United States	University of North Carolina Trauma Center	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Daily average pain score (0-10 numeric rating pain score recorded daily from patient) after study drug initiation.		Study days 1, 3, 5, 7, 10, 13, 17, and 19	No
Secondary	Sleep quality		MOS Sleep Scale	No
Secondary	Anxiety symptoms		7 days, 6 weeks, 3 months, 6 months	No