DOSE Trial of Opioid Sparing Effect

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Dexmedetomidine, Mechanical Ventilation Complication, Critically Ill

In brief

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.

Key facts

Study ID

NCT03938857

Run by

Duke University

People needed

30

Starts

2019-07-18

Expected to finish

2020-11-06

Last updated by the study team

2021-11-05

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Previous participation in this study.
• Severe traumatic brain injury as the underlying etiology for critical illness requiring mechanical ventilation or baseline pediatric cerebral performance category (PCPC) >3.
• Planned receipt of sedatives other than fentanyl or dexmedetomidine.
• Anticipated receipt of neuromuscular blockade for >48 consecutive hours during the study period.
• Receipt of fentanyl or dexmedetomidine via continuous infusion for >12 hours in the 24 hours prior to enrollment.
• Extracorporeal life support (including renal replacement therapy, extracorporeal membrane oxygenation, ventricular assist device, etc.) at the time of enrollment.
• 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)
• Known pregnancy
• Known liver dysfunction, defined as: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2x the upper limit of normal for age
• Known or impending renal failure defined as: anuria > or equal to 12 hours prior to enrollment or requiring renal replacement therapy
• 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)
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.