Cycling of Sedative Infusions in Critically Ill Pediatric Patients
NCT ID: NCT01333059
Last Updated: 2019-01-15
Study Results
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View full resultsBasic Information
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TERMINATED
NA
25 participants
INTERVENTIONAL
2010-09-30
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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
Midazolam
Normal saline
Fentanyl
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.
Midazolam
Fentanyl
Interventions
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Midazolam
Normal saline
Fentanyl
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Javier Gelvez, MD
OTHER
Responsible Party
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Javier Gelvez, MD
M.D.
Principal Investigators
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Javier Gelvez, MD
Role: PRINCIPAL_INVESTIGATOR
Cook Children's Physician Network
Linda L Thompson, MD
Role: PRINCIPAL_INVESTIGATOR
Cook Children's Physician Network
Locations
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Cook Children's Medical Center
Fort Worth, Texas, United States
Countries
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References
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Kress JP, Pohlman AS, O'Connor MF, Hall JB. Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. N Engl J Med. 2000 May 18;342(20):1471-7. doi: 10.1056/NEJM200005183422002.
Kollef MH, Levy NT, Ahrens TS, Schaiff R, Prentice D, Sherman G. The use of continuous i.v. sedation is associated with prolongation of mechanical ventilation. Chest. 1998 Aug;114(2):541-8. doi: 10.1378/chest.114.2.541.
Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.
Ista E, van Dijk M, Tibboel D, de Hoog M. Assessment of sedation levels in pediatric intensive care patients can be improved by using the COMFORT "behavior" scale. Pediatr Crit Care Med. 2005 Jan;6(1):58-63. doi: 10.1097/01.PCC.0000149318.40279.1A.
van Dijk M, Peters JW, van Deventer P, Tibboel D. The COMFORT Behavior Scale: a tool for assessing pain and sedation in infants. Am J Nurs. 2005 Jan;105(1):33-6. doi: 10.1097/00000446-200501000-00019. No abstract available.
Kress JP, Gehlbach B, Lacy M, Pliskin N, Pohlman AS, Hall JB. The long-term psychological effects of daily sedative interruption on critically ill patients. Am J Respir Crit Care Med. 2003 Dec 15;168(12):1457-61. doi: 10.1164/rccm.200303-455OC. Epub 2003 Oct 2.
Kress JP, Vinayak AG, Levitt J, Schweickert WD, Gehlbach BK, Zimmerman F, Pohlman AS, Hall JB. Daily sedative interruption in mechanically ventilated patients at risk for coronary artery disease. Crit Care Med. 2007 Feb;35(2):365-71. doi: 10.1097/01.CCM.0000254334.46406.B3.
Colville G, Kerry S, Pierce C. Children's factual and delusional memories of intensive care. Am J Respir Crit Care Med. 2008 May 1;177(9):976-82. doi: 10.1164/rccm.200706-857OC. Epub 2008 Jan 31.
Connolly D, McClowry S, Hayman L, Mahony L, Artman M. Posttraumatic stress disorder in children after cardiac surgery. J Pediatr. 2004 Apr;144(4):480-4. doi: 10.1016/j.jpeds.2003.12.048.
Related Links
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Click here for more information about this study: A randomized, double-blind, controlled trial of cycling continuous sedative infusions in critically ill pediatric patients requiring mechanical ventilation
Other Identifiers
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Sedation Cycling
Identifier Type: -
Identifier Source: org_study_id
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