Exogenous melatonin administration for primary prevention of delirium in critically ill pediatric patients: A Pilot Study
Study ID: STU 042017-042
Summary
This is a single-center, prospective, double-blinded, randomized controlled pilot study. The primary endpoint will be the development of delirium. Secondary endpoints include total cumulative narcotic and benzodiazepine dose, time spent at goal sedation level as indicated by percentage of state behavioral state (SBS) score at goal level, duration of invasive mechanical ventilation, and iCu length of stay. The investigational pharmacy will randomize patients in 1:1 block randomization after age stratification (0 - 6 yrs, 6yrs 1d - 18 yrs) to the intervention or placebo arm. Patients in the treatment arm will receive melatonin for 5 consecutive evenings or until PiCu discharge, whichever occurs sooner. Control patients will receive placebo for 5 days or until PiCu discharge, whichever occurs sooner. The development and resolution of delirium will be determined by twice-daily nursing bedside assessments utilizing the Cornell assessment of Pediatric Delirium (CaPD) scoring tool. CaPD has been validated for use in children of all ages (0 x 21 years).
Participant Eligibility
1. Patients 0 to 18 years of age 2. Patients admitted to the pediatric intensive care unit 3. Patients receiving continuous sedative infusion 4. Patients requiring invasive mechanical ventilation 5. Current intubation occurred within the preceding 48 hours
We hypothesize that melatonin, when administered for up to 5 consecutive nights in critically ill children, will decrease the incidence of delirium when compared to placebo.
