PMID- 24238862
OWN - NLM
STAT- MEDLINE
DCOM- 20140325
LR  - 20220410
IS  - 1097-6833 (Electronic)
IS  - 0022-3476 (Linking)
VI  - 164
IP  - 2
DP  - 2014 Feb
TI  - A phase II/III, multicenter, safety, efficacy, and pharmacokinetic study of 
      dexmedetomidine in preterm and term neonates.
PG  - 276-82.e1-3
LID - S0022-3476(13)01230-4 [pii]
LID - 10.1016/j.jpeds.2013.10.002 [doi]
AB  - OBJECTIVE: To investigate the safety, efficacy, and pharmacokinetic profile of 
      dexmedetomidine in preterm and full-term neonates >/= 28 to </= 44 weeks gestational 
      age. STUDY DESIGN: Forty-two intubated, mechanically ventilated patients (n = 42) 
      were grouped by gestational age into group I (n = 18), >/= 28 to <36 weeks, and 
      group II (n = 24), >/= 36 to </= 44 weeks. Within each age group, there were 3 
      escalating dose levels, including a loading dose (LD, mug/kg) followed by a 
      maintenance dose (MD, mug . kg(-1) . h(-1)) for 6-24 hours: level 1, 0.05 LD/MD; 
      level 2, 0.1 LD/MD; and level 3, 0.2 LD/MD. The primary endpoint was the number 
      of patients requiring sedation as determined by the Neonatal Pain, Agitation, 
      Sedation Scale. RESULTS: During dexmedetomidine infusion, 5% of Neonatal Pain, 
      Agitation, Sedation Scale scores were >3, indicating agitation/pain, with 4 
      patients (10%) requiring more sedation and 17 (40%) requiring more analgesia. 
      Though there was significant variability in pharmacokinetic variables, group I 
      appeared to have lower weight-adjusted plasma clearance (0.3 vs 0.9 L . h(-1) . 
      kg(-1)) and increased elimination half-life (7.6 vs 3.2 hours) compared with 
      group II. Fifty-six adverse events (AEs) were reported in 26 patients (62%); only 
      3 AEs (5%) were related to dexmedetomidine. There were no serious AEs and no AEs 
      or hemodynamic changes requiring dexmedetomidine discontinuation. CONCLUSION: 
      Dexmedetomidine is effective for sedating preterm and full-term neonates and is 
      well-tolerated without significant AEs. Preterm neonates had decreased plasma 
      clearance and longer elimination half-life.
CI  - Copyright (c) 2014 The Authors. Published by Mosby, Inc. All rights reserved.
FAU - Chrysostomou, Constantinos
AU  - Chrysostomou C
AD  - Department of Pediatric Critical Care Medicine, Cardiac Intensive Care Unit, 
      Children's Hospital of Pittsburgh of UPMC, Pittsburgh, PA. Electronic address: 
      chrycx@chp.edu.
FAU - Schulman, Scott R
AU  - Schulman SR
AD  - Department of Anesthesiology, Duke Children's Hospital, Durham, NC.
FAU - Herrera Castellanos, Mario
AU  - Herrera Castellanos M
AD  - Department of Pediatrics, Hospital Roosevelt, Guatemala City, Guatemala.
FAU - Cofer, Benton E
AU  - Cofer BE
AD  - Neonatology, Greenville Hospital System, Greenville, SC.
FAU - Mitra, Sanjay
AU  - Mitra S
AD  - Department of Pediatrics, West Virginia University Hospitals and Clinics, Ruby 
      Memorial Hospital, Morgantown, WV.
FAU - da Rocha, Marcelo Garcia
AU  - da Rocha MG
AD  - Global Clinical R & D and Medical Affairs, Hospira Inc, Lake Forest, IL.
FAU - Wisemandle, Wayne A
AU  - Wisemandle WA
AD  - Global Clinical R & D and Medical Affairs, Hospira Inc, Lake Forest, IL.
FAU - Gramlich, Lisa
AU  - Gramlich L
AD  - Department of Anesthesiology, Loyola University Medical Center, Maywood, IL.
LA  - eng
SI  - ClinicalTrials.gov/NCT01159262
SI  - ClinicalTrials.gov/NCT01508455
PT  - Clinical Trial, Phase II
PT  - Clinical Trial, Phase III
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20131114
PL  - United States
TA  - J Pediatr
JT  - The Journal of pediatrics
JID - 0375410
RN  - 0 (Hypnotics and Sedatives)
RN  - 67VB76HONO (Dexmedetomidine)
SB  - IM
CIN - Acta Anaesthesiol Scand. 2016 Aug;60(7):865-73. PMID: 26940080
MH  - Dexmedetomidine/administration & dosage/*pharmacokinetics
MH  - Dose-Response Relationship, Drug
MH  - Female
MH  - Follow-Up Studies
MH  - Gestational Age
MH  - Half-Life
MH  - Humans
MH  - Hypnotics and Sedatives/administration & dosage/pharmacokinetics
MH  - Infant, Newborn
MH  - *Infant, Premature
MH  - Infant, Premature, Diseases/blood/*drug therapy
MH  - Infusions, Intravenous
MH  - Male
MH  - Pain Measurement
MH  - Prospective Studies
MH  - Respiration, Artificial
MH  - Treatment Outcome
OTO - NOTNLM
OT  - AE
OT  - AUC
OT  - Adverse event
OT  - Area under the concentration curve
OT  - BP
OT  - Blood pressure
OT  - CL(W)
OT  - HR
OT  - Half-life
OT  - Heart rate
OT  - LD
OT  - Loading dose
OT  - MD
OT  - Maintenance dose
OT  - N-PASS
OT  - Neonatal Pain, Agitation, Sedation Scale
OT  - PK
OT  - Pharmacokinetic
OT  - Plasma clearance
OT  - t(1/2)
EDAT- 2013/11/19 06:00
MHDA- 2014/03/26 06:00
CRDT- 2013/11/19 06:00
PHST- 2013/06/11 00:00 [received]
PHST- 2013/08/06 00:00 [revised]
PHST- 2013/10/01 00:00 [accepted]
PHST- 2013/11/19 06:00 [entrez]
PHST- 2013/11/19 06:00 [pubmed]
PHST- 2014/03/26 06:00 [medline]
AID - S0022-3476(13)01230-4 [pii]
AID - 10.1016/j.jpeds.2013.10.002 [doi]
PST - ppublish
SO  - J Pediatr. 2014 Feb;164(2):276-82.e1-3. doi: 10.1016/j.jpeds.2013.10.002. Epub 
      2013 Nov 14.