DOSE Trial of Opioid Sparing Effect (DOSE)

DEXMEDETOMIDINE OPIOID SPARING EFFECT IN MECHANICALLY VENTILATED CHILDREN: 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

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.

Study Overview

• Status: Terminated
• Conditions: Critically Ill; Dexmedetomidine; Mechanical Ventilation Complication
• Intervention / Treatment: Drug: Fentanyl; Drug: Dexmedetomidine; Drug: Dexmedetomidine; Drug: Dexmedetomidine

Detailed Description

Phase 1b randomized, double-blind, placebo-controlled dose escalation trial of sedation regimens in critically ill children. Testing the hypothesis of mean daily fentanyl dose through day 7 of mechanical ventilation will be reduced by ≥25% by the addition of dexmedetomidine to fentanyl therapy. This trial will involve multiple clinical sites. Randomization will occur by individual and investigators will be blinded to study/treatment arm. The statistical analysis will account for center effects, participant characteristics (including post-surgical state), and changes over time to minimize bias. In addition, PIs and study coordinators will undergo training to standardize assessment procedures. The study will randomize participants to receive placebo (fentanyl standard of care) titrated to sedation+saline placebo (bolus+infusion) or one of the following 3 Dexmedetomidine treatment arms in a sequential cohort fashion: Cohort 1: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2 mcg/kg/hr infusion); Cohort 2: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion); and, Cohort 3: Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion).

An interim analysis is planned for this trial.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida, Shands Children's Hospital
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health, Riley Hospital for Children
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Our Lady of the Lake Children's Hospital
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center, Children's Center
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Masonic Children's Hospital
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University, Cardinal Glennon Children's Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico Children's Hospital
  • New York
    • Buffalo, New York, United States, 14203
      • University of Buffalo, Oishei Children's Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester Medical Center, Golisano Children's Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest Baptist Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Rainbow Babies and Children's Hospital, University Hospitals Cleveland Medical Center
    • Cleveland, Ohio, United States, 44109
      • MetroHealth System, Case CTSA
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University, Doernbecher Children's Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • Drexel University, St. Christopher's Hospital for Children
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina Children's Hospital
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas - Health Science Center San Antonio
  • Utah
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Medical Center- University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Ages 0 to <18 years at the time of enrollment.
2. If < 6 months postnatal age, gestational age ≥ 35 weeks.
3. Admitted to an intensive care unit.
4. Planned or anticipated mechanically ventilation for ≥2 days.
5. Require sedation to maintain mechanical ventilation per clinical judgment.
6. No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment.
7. Availability and willingness of the parent/legal guardian to provide written informed consent.

Exclusion Criteria:

1. Previous participation in this study.
2. Severe traumatic brain injury as the underlying etiology for critical illness requiring mechanical ventilation or baseline pediatric cerebral performance category (PCPC) >3.
3. Planned receipt of sedatives other than fentanyl or dexmedetomidine.
4. Anticipated receipt of neuromuscular blockade for >48 consecutive hours during the study period.
5. Receipt of fentanyl or dexmedetomidine via continuous infusion for >12 hours in the 24 hours prior to enrollment.
6. Extracorporeal life support (including renal replacement therapy, extracorporeal membrane oxygenation, ventricular assist device, etc.) at the time of enrollment.
7. Chronic use of or recent overdose of serotonergic agents (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase (MAO) inhibitors, cyclic antidepressants)
8. Known pregnancy
9. Known liver dysfunction, defined as: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2x the upper limit of normal for age
10. Known or impending renal failure defined as: anuria > or equal to 12 hours prior to enrollment or requiring renal replacement therapy
11. High risk children, define as: a. known heart block b. known bradyarrythmia including clinically significant bradycardia (defined as requiring chronotropic agents or cardiac pacing to treat)
12. Receipt of mechanical ventilation during an admission for cardiac surgery

Note: receipt of drugs other than fentanyl or dexmedetomidine for intubation, and receipt of neuromuscular blockage for intubation, will not be considered exclusionary criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Fen. SOC+saline placebo (bolus+infusion); Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)	Drug: Fentanyl; Fentanyl standard of care
Active Comparator: Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr); Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)	Drug: Fentanyl; Fentanyl standard of care; Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr); Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr); Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)
Active Comparator: Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr); Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)	Drug: Fentanyl; Fentanyl standard of care; Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr); Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr); Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)
Active Comparator: Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr); Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)	Drug: Fentanyl; Fentanyl standard of care; Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr); Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr); Drug: Dexmedetomidine; Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Daily Dose of Fentanyl in mcg/kg/hr (Micrograms Per Kilogram Per Hour)	Characterize the opioid-sparing effect of dexmedetomidine when co-administered with fentanyl in children receiving mechanical ventilation. Characterization of differences between dosing exposures for the four groups will allow estimation of the opioid-sparing effect of dexmedetomidine.	through day 7 of mechanical ventilation or initial extubation (whichever is first)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation Based on the State Behavior Scale (SBS) Relative to Fentanyl Plasma Concentrations (Cmax)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Cmin)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (Css)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on SBS Scale Relative to Fentanyl Plasma Concentrations (AUC)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (Css)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on SBS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The SBS is a 6-point scale that ranges from +2 to -3 with -3. Scores that are more negative reflect a more sedated state (-3). Scores that are more positive reflect a more agitated state (+2). Zero is awake and easily calmed.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on Richmond Agitation and Sedation Scale (RASS) Scale Relative to Fentanyl Plasma Concentrations (Cmax)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Cmin)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-pint scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (Css)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on RASS Scale Relative to Fentanyl Plasma Concentrations (AUC)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmax)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Cmin)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (Css)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Sedation Based on RASS Scale Relative to Dexmedetomidine Plasma Concentrations (AUC)	Characterize the exposure response relationships of fentanyl and dexmedetomidine when administered alone or in combination in children receiving mechanical ventilation. PK is known to be altered in children compared to adults, and in those with critical illness. Characterization of pharmacokinetic-pharmacodynamic relationships can improve dose optimization when dose may not be equivalent to plasma exposure and related effect. The RASS scale is a 10-point scale that ranges from -5 to +4 with -5=unarousable and +4=combative. Zero means the patient is alert and calm.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Number of Participants Experiencing a Clinically Significant Episode of Hypotension	Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.	up to 28 days or until discharge from the ICU (whichever is first)
Number of Participants Experiencing SAEs (Serious Adverse Events)		up to 28 days or until discharge from the ICU (whichever is first)
Mean Number of SAEs (Serious Adverse Events) Experienced by Participants		up to 28 days or until discharge from the ICU (whichever is first)
Number of Participants Experiencing a Clinically Significant Episode of Bradycardia	Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.	up to 28 days or until discharge from the ICU (whichever is first)
Number of Participants Experiencing a Clinically Significant Episode of Urinary Retention	Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.	up to 28 days or until discharge from the ICU (whichever is first)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Cornell Assessment of Pediatrics in Delirium (CAPD) Scores	Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Maximum Daily CAPD Scores	Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Minimum Daily CAPD Scores	Estimate the incidence of intensive care unit delirium in children exposed to fentanyl and dexmedetomidine alone or in combination when receiving mechanical ventilation. (Measures of delirium). The CAPD scale goes from 0-4 and has 8 questions. All items scored as occurring never, rarely, sometimes, often, or always. Individual item scores are added for a sum total score.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Average Daily Withdrawal Assessment Tool (WAT-1) Score	Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Minimum Daily WAT-1 Score	Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.	through day 7 of mechanical ventilation or initial extubation (whichever is first)
Maximum Daily WAT-1 Score	Estimate the incidence of opioid withdrawal syndrome in children exposed to fentanyl and dexmedetomidine when administered alone or in combination when receiving mechanical ventilation. (Measures of withdrawal). WAT-1 scale is 0=no/none and 1=yes/moderate/severe. Total score is on a 0-12 scale where lower is better.	through day 7 of mechanical ventilation or initial extubation (whichever is first)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Johns Hopkins University; National Institutes of Health (NIH); Vanderbilt University Medical Center; Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Daniel Benjamin, MD, Duke Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Actual): October 21, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: May 2, 2019
• First Posted (Actual): May 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Hypnotics and Sedatives; Adjuvants, Anesthesia; Fentanyl; Dexmedetomidine
• Other Study ID Numbers: Pro00102267; 5U24TR001608 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No