DOSE Trial of Opioid Sparing Effect

Phase 1 Terminated 30 enrolled Duke University Intermountain Health Care, Inc. · collab Johns Hopkins University · collab National Institutes of Health (NIH) · collab Vanderbilt University Medical Center · collab

RandomizedSequentialTriple-blindTreatment

Summary

Multicenter, double blind randomized controlled trial of fentanyl vs. fentanyl + dexmedetomidine as the initial regimen for maintenance of sedation in mechanically-ventilated, critically ill children. This trial will evaluate the opioid-sparing effect of dexmedetomidine when administered with fentanyl to mechanically ventilated, critically ill children. Study drug or placebo will be administered with fentanyl, which will be titrated to achieve sedation scores consistent with response to light touch. Plasma samples and bedside assessments for pain, sedation, and delirium will be collected.

Timeline

Start: 2019-07-18
Primary completion: 2020-10-21
Completion: 2020-11-06

Publications

Boutzoukas AE, Olson R, Sellers MA, Fischer G, Hornik CD, Alibrahim O, Iheagwara K, Abulebda K, Bass AL, Irby K, Subbaswamy A, Zivick EE, Sweney J, Stormorken AG, Barker EE, Lutfi R, McCrory MC, Costello JM, Ackerman KG, Munoz Pareja JC, Dean JM, Abdelsamad N, Hanley DF Jr, Mould WA, Lane K, Stroud M, Feger BJ, Greenberg RG, Smith PB, Benjamin DK Jr, Hornik CP, Zimmerman KO, Becker ML. Mechanisms to expedite pediatric clinical trial site activation: The DOSE trial experience. Contemp Clin Trials. 2023 Feb;125:107067. doi: 10.1016/j.cct.2022.107067. Epub 2022 Dec 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Dexmedetomidine	Other / unclassified	0.2 ug/kg	—
Comparator	Dexmedetomidine	Other / unclassified	0.5 ug/kg	—
Comparator	Dexmedetomidine	Other / unclassified	0.7 ug/kg	—
Comparator	Fentanyl	Other / unclassified	—	—

Indications

No indication recorded.