Goal-Directed Sedation in Mechanically Ventilated Infants and Children

PHASE3RecruitingINTERVENTIONAL
Enrollment

372

Participants

Timeline

Start Date

May 10, 2021

Primary Completion Date

April 17, 2026

Study Completion Date

September 16, 2026

Conditions
DeliriumCritical IllnessSedation ComplicationExecutive DysfunctionPost Traumatic Stress Disorder
Interventions
DRUG

Dexmedetomidine

For patients in the dexmedetomidine group, dose will range from 0.2-2.0 mcg/kg/hr. For example, a 10 kg patient on an infusion of 1 mcg/kg/hr of dexmedetomidine would receive 10 mcg of study drug per hour. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the mini-MENDS study steering committee.

DRUG

Midazolam

For patients in the midazolam group, dose will range from 0.025-0.25 mg/kg/hr. For example, a 10 kg patient on an infusion of 0.15 mg/kg/hr of midazolam would receive 1.5 mg of midazolam per hour. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the mini-MENDS study steering committee.

Trial Locations (1)

37232

RECRUITING

Vanderbilt University Medical Center, Nashville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Pfizer

INDUSTRY

collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

lead

Vanderbilt University Medical Center

OTHER