Clinical trial NCT01333059
Conditions: Respiratory Failure
Keywords: Sedation Cycling Pediatric
Sponsor: Javier Gelvez, MD
Start date: 2010-09-01; Completion date: 2013-01-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
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.

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.

Arms: arm 1: 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 arm 2: 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.
Interventions: intervention 1: Midazolam intervention 2: Normal saline intervention 3: Fentanyl
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: