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OpenTrials
Completed

NCT Number: NCT00697788

Dexmedetomidine Cardiovascular Safety in Pediatric Burn Patients

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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Key information

Conditions

Burns Sedation Wounds and Injuries

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shriners Burn Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

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.

Other names: Precedex

Primary outcomes

  1. Percent Change in Mean Arterial Pressure (MAP)

    Time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

    Looking at hemodynamic response to dexmedetomidine. Mean arterial pressure primary outcome measure.

Secondary outcomes

  1. Presence of Arrhythmias.

    Time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

    Presence of arrhythmias was studied using a 3 lead realtime EKG throughout study.

  2. Oxygen Saturation

    Time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

    Pulse oximetry was used to measure oxygen saturation.

  3. Heart Rate

    Time frame: 10, 25, 40, 55, 70, 85, 100, 115 minutes after dexmedetomidine bolus administration

    Heart Rate recorded off EKG in beats per minute

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Official study title

Cardiovascular Safety of Dexmedetomidine in Pediatric Burn Patients.

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 16, 2008
Registry last updated
Jul 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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