A Phase 1 interventional study of Fentanyl and Dexmedetomidine in Dexmedetomidine, Mechanical Ventilation Complication and Critically Ill, sponsored by Duke University. Terminated at 19 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2021-11-05.
Sponsored by Duke University · Phase 1, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
Note: receipt of drugs other than fentanyl or dexmedetomidine for intubation, and receipt of neuromuscular blockage for intubation, will not be considered exclusionary criteria.
Fentanyl standard of care (SOC) titrated to sedation + saline placebo (bolus + infusion)
Drug: Fentanyl
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.2mcg/kg/hr infusion)
Drug: Fentanyl · Drug: Dexmedetomidine
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.5mcg/kg/hr infusion)
Drug: Fentanyl · Drug: Dexmedetomidine
Fentanyl SOC titrated to sedation + Dexmedetomidine (0.5mcg/kg bolus load + 0.7mcg/kg/hr infusion)
Drug: Fentanyl · Drug: Dexmedetomidine
Fentanyl standard of care
Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)
Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)
Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)
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.
Time frame: through day 7 of mechanical ventilation or initial extubation (whichever is first)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: up to 28 days or until discharge from the ICU (whichever is first)
Number of Participants Experiencing SAEs (Serious Adverse Events)
Time frame: up to 28 days or until discharge from the ICU (whichever is first)
Mean Number of SAEs (Serious Adverse Events) Experienced by Participants
Time frame: 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.
Time frame: 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.
Time frame: up to 28 days or until discharge from the ICU (whichever is first)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through day 7 of mechanical ventilation or initial extubation (whichever is first)
Subjects enrolled were in a pediatric intensive care setting, critically ill and requiring ventilatory support and pain management associated with such.
| Milestone | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| Started | 6 | 12 | 12 | 0 |
| Completed | 5 | 12 | 12 | 0 |
| Not completed | 1 | 0 | 0 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 0 |
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.
| mcg/kg/hr | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| Mean Daily Dose of Fentanyl in mcg/kg/hr (Micrograms Per Kilogram Per Hour) | 2.25 ± 2.15 | 2.68 ± 1.53 | 3.23 ± 3.30 | — |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.
| Participants | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| Number of Participants Experiencing a Clinically Significant Episode of Hypotension | 2 | 5 | 3 | — |
| Participants | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| Number of Participants Experiencing SAEs (Serious Adverse Events) | 0 | 2 | 1 | — |
| serious adverse events | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| Mean Number of SAEs (Serious Adverse Events) Experienced by Participants | — | 1 ± 0 | 1 ± NA | — |
Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.
| Participants | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| Number of Participants Experiencing a Clinically Significant Episode of Bradycardia | 2 | 3 | 1 | — |
Characterize the safety profile of fentanyl and dexmedetomidine when administered alone or in combination to children receiving mechanical ventilation.
| Participants | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| Number of Participants Experiencing a Clinically Significant Episode of Urinary Retention | 1 | 2 | 1 | — |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Collected over Up to 28 days or until discharge from the ICU (whichever is first). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fen. SOC+Saline Placebo (Bolus+Infusion) | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | 0/12 (0%) | 2/12 (16.7%) | 9/12 (75%) |
| Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | 0/12 (0%) | 1/12 (8.3%) | 8/12 (66.7%) |
| Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | — | — | — |
| Event | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| General signs and symptoms NECGeneral disorders | 0/6 | 1/12 | 0/12 | — |
| Colitis (excl infective)Gastrointestinal disorders | 0/6 | 1/12 | 0/12 | — |
| Seizures and seizure disorder NECNervous system disorders | 0/6 | 0/12 | 1/12 | — |
| Event | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) |
|---|---|---|---|---|
| Vascular hypotensive disordersVascular disorders | 3/6 | 6/12 | 5/12 | — |
| Rate and rhythm disorders NECCardiac disorders | 2/6 | 5/12 | 5/12 | — |
| Febrile disordersGeneral disorders | 2/6 | 0/12 | 1/12 | — |
| Bladder and urethral symptomsRenal and urinary disorders | 1/6 | 2/12 | 1/12 | — |
| Heart rate and pulse investigationsInvestigations | 1/6 | 0/12 | 0/12 | — |
| Laryngeal spasm, oedema and obstructionRespiratory, thoracic and mediastinal disorders | 1/6 | 0/12 | 0/12 | — |
| Parainfluenzae viral infectionsInfections and infestations | 1/6 | 0/12 | 0/12 | — |
| Renal failure and impairmentRenal and urinary disorders | 0/6 | 2/12 | 0/12 | — |
| Respiratory tract and thoracic cavity procedural complicationsInjury, poisoning and procedural complications | 0/6 | 2/12 | 0/12 | — |
| Anaesthetic and allied procedural complicationsInjury, poisoning and procedural complications | 0/6 | 1/12 | 0/12 | — |
Study was prematurely terminated and no participants were enrolled in the Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) group.
| Age, Continuous(years) | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Total |
|---|---|---|---|---|---|
| Mean | 3.8 ± 6.8 | 2.5 ± 2.8 | 2.6 ± 3.7 | — | 2.8 ± 4.0 |
| Sex: Female, Male(Participants) | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Total |
|---|---|---|---|---|---|
| Female | 3 | 5 | 4 | — | 12 |
| Male | 3 | 7 | 8 | — | 18 |
| Ethnicity (NIH/OMB)(Participants) | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 | — | 2 |
| Not Hispanic or Latino | 5 | 11 | 10 | — | 26 |
| Unknown or Not Reported | 1 | 0 | 1 | — | 2 |
| Race (NIH/OMB)(Participants) | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | — | 0 |
| Asian | 0 | 0 | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | — | 0 |
| Black or African American | 3 | 3 | 1 | — | 7 |
| White | 3 | 8 | 8 | — | 19 |
| More than one race | 0 | 0 | 1 | — | 1 |
| Unknown or Not Reported | 0 | 1 | 2 | — | 3 |
| Region of Enrollment(Participants) | Fen. SOC+Saline Placebo (Bolus+Infusion) | Fen. SOC+Dex.(.5mcg/kg + .25mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .5mcg/kg/hr) | Fen. SOC+Dex.(.5mcg/kg + .75mcg/kg/hr) | Total |
|---|---|---|---|---|---|
| United States | 6 | 12 | 12 | — | 30 |
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