Cycling of Sedative Infusions in Critically Ill Pediatric Patients

January 2, 2019 updated by: Javier Gelvez, MD

A Randomized, Double-blind, Controlled Trial of Cycling Continuous Sedative Infusions in Critically Ill Pediatric Patients Requiring Mechanical Ventilation

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Cook Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group

In this arm Fentanyl and Midazolam was replaced with placebo (normal saline) during cycling.

At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the placebo drug (normal saline). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the placebo drug (normal saline), was started. The switch Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.

Dosing was done per standard of care and not prescribed per protocol
Drug: Fentanyl
Other Names:
  • Subsys, Duragesic, Abstral, Lazanda, IONSYS, Study Drug F
Drug: Midazolam
Other Names:
  • Versed, Study Drug M
Drug: Normal saline
Other Names:
  • Placebo
Active Comparator: Control Group

In this arm, midazolam and fentanyl were administered during cycling.

At cycling time for midazolam, the continuous infusion of midazolam was stopped by the bedside nurse. The nurse started a pump containing a syringe labeled "Study Drug M" which contained the control drug (midazolam). The switch to Study Drug M occurred twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl was stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which contained the control drug (fentanyl), was started. The switch to Study Drug F occurred twice daily at 1400 and 0200 for a period of 3 hours each.

Dosing was done per standard of care and not prescribed per protocol.
Drug: Fentanyl
Other Names:
  • Subsys, Duragesic, Abstral, Lazanda, IONSYS, Study Drug F
Drug: Midazolam
Other Names:
  • Versed, Study Drug M

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Mechanical Ventilation Days
Time Frame: From date of randomization until the date of discharge from PICU, assessed up to 1 month
Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.
From date of randomization until the date of discharge from PICU, assessed up to 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PICU Length of Stay
Time Frame: From date of randomization until the date of discharge from PICU, assessed up to 1 month
Participants will be followed for an expected average of 7 days. This secondary endpoint is to be evaluated every six months.
From date of randomization until the date of discharge from PICU, assessed up to 1 month
Hospital Length of Stay
Time Frame: From date of hospital admission to date of hospital discharge, assessed up to 6 weeks
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.
From date of hospital admission to date of hospital discharge, assessed up to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Javier Gelvez, MD

Investigators

  • Principal Investigator: Javier Gelvez, MD, Cook Children's Physician Network
  • Principal Investigator: Linda L Thompson, MD, Cook Children's Physician Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 6, 2011

First Submitted That Met QC Criteria

April 8, 2011

First Posted (Estimate)

April 11, 2011

Study Record Updates

Last Update Posted (Actual)

January 15, 2019

Last Update Submitted That Met QC Criteria

January 2, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sedation Cycling

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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