Propranolol in Severely Burned Children

The University of Texas System (UT)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Burn

Treatments: Drug: Propranolol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01957449

13-103

Details and patient eligibility

About

To determine the safety and efficacy of administration of propranolol for reducing heart rate and blood pressure in burn injury.

Full description

Other purposes of this study are to study the effect on muscle function, the infectious process, sepsis, systemic inflammation and long-term scarring. Quality of life will also be looked at over time.

Enrollment: 63 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Burns covering >20% of the total body surface are
• Age of 0 to 18 years
• Patient arrival to the burn center within 96 hours (4 days) of burn injury
• Require > 1 surgical procedure

Exclusion criteria

• Pregnancy
• Known history of AIDS, Aids Related Complex, or HIV
• History of cancer within 5 years
• Existence of pre-morbid conditions
• Asthma
• Congestive heart failure (measured ejection fraction < 20%)
• Medical condition requiring glucocorticoid treatment
• Burn injury due to chemical burns
• Burn injury due to deep electrical injury (decision of hospital PI)
• Presence of anoxic brain injury that is not expected to result in complete recovery
• Decision not to treat due to burn injury severity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 2 patient groups, including a placebo group

Propranolol

Active Comparator group

Description:

Propranolol by mouth given daily throughout hospitalization for up to 12 months

Treatment:

Drug: Propranolol

Sugar Pill

Placebo Comparator group

Description:

Placebo by mouth given daily throughout hospitalization for up to 12 months

Treatment:

Drug: Placebo