Propranolol in Severely Burned Children

Safety and Efficacy of Propranolol in Severely Burned Children

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01957449

Enrollment

Registered

2013-10-08

Start date

2013-12-31

Completion date

2019-04-23

Last updated

2019-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn

Brief summary

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

Detailed 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.

Interventions

DRUGPropranolol

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Resting heart rate multiplied by the systolic blood pressure measurement= rate pressure product	Measured during acute hospital stay, an average of 4 weeks.	Multiply the subjects resting heart rate and systolic blood pressure measurements and average every 24 hours while hospitalized (an average of 4 weeks)

Secondary

Measure	Time frame	Description
Number of deaths	time of randomization up to one year	Number of deaths will be compared between placebo group and propranolol treatment groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026