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DOSE Trial of Opioid Sparing Effect

NCT03938857 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-11-05

Study results available
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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.

Conditions

  • Dexmedetomidine
  • Mechanical Ventilation Complication
  • Critically Ill

Interventions

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)

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Johns Hopkins University

    collaborator OTHER

  • Intermountain Health Care, Inc.

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Daniel Benjamin, MD · Duke Clinical Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-18
Primary Completion
2020-10-21
Completion
2020-11-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03938857 on ClinicalTrials.gov