Cycling of Sedative Infusions in Critically Ill Pediatric Patients

Javier Gelvez, MD25 enrolled

Overview

The purpose of this study is to determine if the reduction of the total amount of sedative critically pediatric ill patients receive in the PICU will achieve a significant decrease in mechanical ventilation days and a decrease in the overall length of stay in the PICU and hospital.

Continuous sedative infusions have been associated with longer duration of mechanical ventilation, longer stay in the intensive care unit (PICU) and total hospital stay. Also, extended duration of continuous sedative infusions limits the ability to assess for adequate neurologic function. There is, however, no published data on the use of daily interruption of continuous sedative infusions in pediatric patients, nor are there any recommendations from the leading pediatric critical care groups regarding this issue. Infants and children exposed to noxious stimuli (endotracheal tube, endotracheal suctioning, mechanical ventilation, indwelling catheters) in addition to an unknown environment are less likely to cooperate during normal daily interventions in the PICU. Continuous infusions of benzodiazepines and opioids in addition to as needed (PRN) bolus doses have been the standard of care in our institution for mechanically ventilated patients. The study seeks to determine if reducing the total dose of sedatives, by holding them in a cyclical manner, will be a safe and effective intervention that will not increase adverse patient outcomes. This will be achieved by limiting the patient tolerance to the sedatives, decreasing the body total deposit of sedatives and subsequently decreases awakening time when patient is ready for extubation.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Respiratory Failure

Interventions

MidazolamDRUG

Normal salineDRUG

FentanylDRUG

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Less than or equal to 18 years of age * Intubated and mechanically ventilated * Expected to require continuous infusions of sedatives for at least 48 hours * Parent or legal guardian available for informed consent * Males and females of any race are eligible Exclusion Criteria: * Less than 72 hours after surgery * Cyanotic heart disease with unrepaired or palliated right to left intracardiac shunt * Critical airway (according to PICU Attending) * Ventilator dependent (including noninvasive) on PICU admission * Greater than 48 hours of continuous sedation infusion(s) * Neuromuscular respiratory failure * Managed by patient controlled analgesia (PCA) or epidural catheter * Known allergy to any of the study medications (fentanyl or midazolam) * Family/Medical team have decided not to provide full support (patient treatment considered futile) * Patient requires ECMO * Head trauma requiring intracranial pressure monitoring * Pregnancy * Following resuscitation from cardiorespiratory arrest whose initial pH is \< 6.9 * ICU Attending judgment that patient should be excluded for safety reasons

Locations (1)

Cook Children's Medical Center

Fort Worth, Texas, United States

Outcomes

Primary Outcomes

Duration of Mechanical Ventilation Days

Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.

Time frame: From date of randomization until the date of discharge from PICU, assessed up to 1 month

Secondary Outcomes

PICU Length of Stay

Participants will be followed for an expected average of 7 days. This secondary endpoint is to be evaluated every six months.

Time frame: From date of randomization until the date of discharge from PICU, assessed up to 1 month

Hospital Length of Stay

Participants will be followed for an expected average of 7 days in PICU and 10 days of hospitalization. This secondary endpoint is to be evaluated every six months.

Time frame: From date of hospital admission to date of hospital discharge, assessed up to 6 weeks

Data from ClinicalTrials.gov

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