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Propranolol in Severely Burned Children

The University of Texas System (UT) logo

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

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

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

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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