A Phase 1b, Multicenter, double blind randomized controlled dose escalating trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children

Date Added
June 20th, 2019
PRO Number
John Costello

List of Studies


We are asking children to be in the study because he/she needs pain
medicine and also needs a breathing machine while in the intensive care unit. Children who are on a breathing machine in the intensive care unit are usually given a drug called fentanyl to treat pain. But fentanyl can be addictive and children can have withdrawal effects when the medicine is stopped. This
study will test whether adding another medication, dexmedetomidine, will reduce the amount of fentanyl needed while children are on the breathing machine. Every child in the study will get regular pain medicine. They will also receive either the study drug or the placebo (fluid with no drugs in it). This means not all children will get the study drug. Approximately 75% of the participants will receive
the study drug and 25% will receive the placebo.
Children will receive either fentanyl with the study drug (dexmedetomidine) or fentanyl with saline placebo for up to 7 days. The study doctors will follow each participant for a total of up to 28 days.

Recruitment Contact
Kalyan Chundru

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