TRAUMA HELP: Healing and Analgesia With Propranolol (TRAUMA_HELP)

University of North Carolina (UNC)

Status and phase: Withdrawn; Phase 2

Conditions: Trauma

Treatments: Drug: Propranolol ER; Drug: Sugar pills; Drug: Propranolol

Study type: Interventional

Funder types: Other

Identifiers

NCT01007084

09-1391

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Propranolol

Experimental group

Treatment:

Drug: Propranolol

Drug: Propranolol ER

Sugar pill

Placebo Comparator group

Treatment:

Drug: Sugar pills