Phase 3
Completed N=36
Safety, Efficacy and Pharmacokinetic Study of Dexmedetomidine in Pediatrics Ages ≥28 Weeks to ≤44 Weeks Gestational Age
Sedation
Source: ClinicalTrials.gov NCT01159262 ↗
Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion — 7.1; 7.1; 25 percentage of subjects
Summary
The purpose of this study is to investigate the safety, efficacy and pharmacokinetics (PK) of dexmedetomidine (DEX) at 3 different dose levels in infants, ages ≥28 weeks to ≤44 weeks gestational age, administered as a loading dose followed by a continuous infusion for a minimum of 6 hours and up to 24 hours in the neonatal intensive care unit (NICU), cardiac intensive care unit (CICU), or pediatric intensive care unit (PICU).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Who Received Rescue Medication Midazolam for Sedation During Dexmedetomidine Infusion |
7.1; 7.1; 25 | — |
| SECONDARY Percentage of Subjects Who Received Rescue Medication for Analgesia During Dexmedetomidine Infusion |
35.7; 35.7; 75 | — |
| SECONDARY Total Amount of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used) |
.360; .500; 1.125 | — |
| SECONDARY Total Amount of Rescue Medication Fentanyl Given for Sedation During Dexmedetomidine Infusion (Among Who Used) |
10.808; 5.667; 9.522 | — |
| SECONDARY Total Amount of Rescue Medication Morphine Given for Sedation During Dexmedetomidine Infusion (Among Who Used) |
0.275; 0.400 | — |
| SECONDARY Weight-adjusted Total Amount (Per kg) of Rescue Medication Midazolam Given for Sedation During Dexmedetomidine Infusion (Among Who Used) |
0.100; 0.152; 0.318 | — |
| SECONDARY Weight-adjusted Total Amount (Per kg) of Rescue Medication Fentanyl Given for Analgesia During Dexmedetomidine Infusion (Among Who Used) |
5.137; 1.863; 2.725 | — |
| SECONDARY Weight-adjusted Total Amount (Per kg) of Rescue Medication Morphine Given for Analgesia During Dexmedetomidine Infusion (Among Who Used) |
0.125; 0.109 | — |
| SECONDARY Time to Successful Extubation in DEX-exposed Subjects |
22.9; 49.3; 23.7 | — |
Eligibility Criteria
Inclusion Criteria
- Initially intubated and mechanically ventilated pediatric subjects in an intensive care setting anticipated to require a minimum of 6 hours of continuous IV sedation.
- The ability to complete all PK sampling blood draws.
- Age: subjects must fit into 1 of the following age ranges at screening:
- Preterm neonates ≥28 weeks through 1000 g.
- Subject's parent(s) or legal guardian(s) has/have voluntarily signed and dated the informed consent document approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC).
Exclusion Criteria
- Neonate subjects with neurological conditions that prohibit an evaluation of sedation such as:
- Diminished consciousness from increased intracranial pressure.
- The presence of catastrophic brain injury or other severe mental disorders that would make responses to sedatives unpredictable and/or measurement of the N-PASS unreliable.
- Subjects with immobility from neuromuscular disease or continuous infusion of neuromuscular blocking (NMB) agents.
- Subjects with second degree or third degree heart block unless subject has a pacemaker or pacing wires are in situ.
- Heart rate 115 U/L.
Data sourced from ClinicalTrials.gov (NCT01159262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.