Cycling of Sedative Infusions in Critically Ill Pediatric Patients
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Respiratory Failure |
Drug: Midazolam/Fentanyl Drug: Sedative Intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-blind, Controlled Trial of Cycling Continuous Sedative Infusions in Critically Ill Pediatric Patients Requiring Mechanical Ventilation |
- Duration of mechanical ventilation days [ Time Frame: Discharge from PICU ] [ Designated as safety issue: No ]Participants will be followed for an expected average of 4 days. The Data Safety Monitoring Group will review the data every 6 months.
- PICU length of stay [ Time Frame: Discharge from PICU ] [ Designated as safety issue: No ]Participants will be followed for an expected average of 7 days. This secondary endpoint is to be evaluated every six months.
- Hospital length of stay [ Time Frame: Discharge from hospital ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | February 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Sedative control
At cycling time for midazolam, the continuous infusion of midazolam will be stopped by the bedside nurse. The nurse will start a pump containing a syringe labeled "Study Drug M" which will contain the control drug (midazolam). The switch to Study Drug M will occur twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl will be stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which will contain the control drug (fentanyl), will be started. The switch to Study Drug F will occur twice daily at 1400 and 0200 for a period of 3 hours each.
|
Drug: Midazolam/Fentanyl
Sedative Control
Drug: Sedative Intervention
Intervention arm - Fentanyl and Midazolam will be replaced with placebo
|
|
Placebo Comparator: Sedative Intervention
At cycling time for midazolam, the continuous infusion of midazolam will be stopped by the bedside nurse. The nurse will start a pump containing a syringe labeled "Study Drug M" which will contain the placebo drug (normal saline). The switch to Study Drug M will occur twice daily at 0800 and 2000 for a period of 3 hours each. At cycling time for fentanyl, the continuous infusion of fentanyl will be stopped by the bedside nurse. The pump containing a syringe labeled "Study Drug F," which will contain the placebo drug (normal saline), will be started. The switch Study Drug F will occur twice daily at 1400 and 0200 for a period of 3 hours each.
|
Drug: Midazolam/Fentanyl
Sedative Control
Drug: Sedative Intervention
Intervention arm - Fentanyl and Midazolam will be replaced with placebo
|
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Texas | |
| Cook Children's Medical Center | |
| Fort Worth, Texas, United States, 76104 | |
| Principal Investigator: | Javier Gelvez, MD | Cook Children's Physician Network |
| Principal Investigator: | Linda L Thompson, MD | Cook Children's Physician Network |
More Information
Additional Information:
Publications:
| Responsible Party: | Javier Gelvez, MD, M.D., Cook Children's Health Care System |
| ClinicalTrials.gov Identifier: | NCT01333059 History of Changes |
| Other Study ID Numbers: | Sedation Cycling |
| Study First Received: | April 6, 2011 |
| Last Updated: | December 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cook Children's Health Care System:
|
Sedation Cycling Pediatric |
Additional relevant MeSH terms:
|
Critical Illness Respiratory Insufficiency Disease Attributes Pathologic Processes Respiration Disorders Respiratory Tract Diseases Midazolam Fentanyl Hypnotics and Sedatives Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Anti-Anxiety Agents Tranquilizing Agents |
Central Nervous System Depressants Physiological Effects of Drugs Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Narcotics Analgesics Sensory System Agents Peripheral Nervous System Agents Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013