Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-16

Study Completion Date

2008-12-30

Brief Summary

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Dexmedetomidine is a sedative drug approved for adult patients, intubated, in intensive care units. We are studying whether this drug is cardiovascularly safe in pediatric patients who have recently been burned.

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Detailed Description

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This is an ascending dose study evaluating the cardiovascular safety of dexmedetomidine bolus/infusions in acutely burned pediatric patients. The study entails a bolus of dexmedetomidine, followed by 2 hours of increasing infusion doses. Cardiovascular parameters including EKG, heart rate, oxygen saturation, blood pressure, are recorded.

Conditions

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Burns Sedation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ascending dose study

Ascending doses of dexmedetomidine (as per protocol)

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine \[in ug/kg/hr\], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.

Interventions

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Dexmedetomidine

Dexmedetomidine bolus 1 ug/kg over 10 minutes, followed by ascending infusion as follows: Dexmedetomidine \[in ug/kg/hr\], each for 15 minutes: 0.7, 1.0, 1.3, 1.6, 1.9, 2.2, 2.5.

Intervention Type DRUG

Other Intervention Names

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Precedex

Eligibility Criteria

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Inclusion Criteria

* pediatric patient
* \>25% total body surface area (tbsa) burn and \< 90% tbsa
* opioid requirements \> 0.1 mg/kg/hour of morphine (or equivalent)
* midazolam requirement \> 0.1 mg/kg/hour
* treatment team determined that patient should be started on dexmedetomidine

Exclusion Criteria

* hemodynamically unstable patients (epinephrine \> 1.0 ug/kg/min, levophed \> 0.75 ug/kg/min, dopamine \> 10 ug/kg/min)
* pregnant patients
* patients with history of heart block
* patients with congenital heart disease
* patients with significant hepatic dysfunction
* patients with urine output \< 0.5 ml/kg/hour \[averaged\] over past 24 hours

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No