title: Morphine versus clonidine for neonatal abstinence syndrome.
abstract: OBJECTIVE
  The study goal was to determine whether clonidine treatment of neonatal abstinence syndrome (NAS) would result in a better neurobehavioral performance compared with morphine.
  
  
  METHODS
  This pilot study prospectively enrolled infants ≥ 35 weeks' gestational age admitted for treatment of NAS. After informed consent was obtained, infants were randomized to receive morphine (0.4 mg/kg per day) or clonidine (5 μg/kg per day) divided into 8 doses. A 25% dose escalation every 24 hours was possible per protocol (maximum of 1 mg/kg per day for morphine and 12 μg/kg per day for clonidine). After control of symptoms, the dose was tapered by 10% every other day. Clinical staff monitored infants by using Finnegan scoring. Masked research staff administered the NICU Network Neurobehavioral Scale (NNNS) at 1 week and at 2 to 4 weeks after initiation of treatment and the Bayley Scales III, and Preschool Language Scale IV, at 1-year adjusted age. Analyses included descriptive statistics, repeated measures analysis of variance, and Wilcoxon tests.
  
  
  RESULTS
  Infants treated with morphine (n = 15) versus clonidine (n = 16) did not differ in birth weight or age at treatment. Treatment duration was significantly longer for morphine (median 39 days) than for clonidine (median 28 days; P = .02). NNNS summary scores improved significantly with clonidine but not with morphine. On subsequent assessment, those receiving clonidine had lower height of arousal and excitability (P < .05). One-year motor, cognitive, and language scores did not differ between groups.
  
  
  CONCLUSIONS
  Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS. A multicenter randomized trial is warranted.
authors.affiliation: Departments of Pediatrics, College of Medicine, hbada2@uky.edu.
authors.forename: Henrietta S
authors.initials: HS
authors.lastname: Bada
authors.affiliation: Departments of Pediatrics, College of Medicine.
authors.forename: Thitinart
authors.initials: T
authors.lastname: Sithisarn
authors.affiliation: Department of Pharmacy, Kentucky Children's Hospital, Lexington, Kentucky; and.
authors.forename: Julia
authors.initials: J
authors.lastname: Gibson
authors.affiliation: Department of Pharmacy, Kentucky Children's Hospital, Lexington, Kentucky; and.
authors.forename: Karen
authors.initials: K
authors.lastname: Garlitz
authors.affiliation: Departments of Pediatrics, College of Medicine.
authors.forename: Rhonda
authors.initials: R
authors.lastname: Caldwell
authors.affiliation: Rehabilitation Sciences, College of Health Sciences.
authors.forename: Gilson
authors.initials: G
authors.lastname: Capilouto
authors.affiliation: Statistics, College of Arts and Sciences and.
authors.forename: Yinglei
authors.initials: Y
authors.lastname: Li
authors.affiliation: Pharmaceutical Sciences, College of Pharmacy, University of Kentucky, Lexington, Kentucky;
authors.forename: Markos
authors.initials: M
authors.lastname: Leggas
authors.affiliation: Department of Biostatistics, College of Public Health, University of Iowa, Iowa City, Iowa.
authors.forename: Patrick
authors.initials: P
authors.lastname: Breheny
mesh_terms: D000700:Analgesics / Q000627:therapeutic use*; D001143:Arousal / Q000187:drug effects; D003000:Clonidine / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D009020:Morphine / Q000627:therapeutic use*; D009357:Neonatal Abstinence Syndrome / Q000534:rehabilitation*; D009293:Opioid-Related Disorders / Q000534:rehabilitation*; D010865:Pilot Projects; D011595:Psychomotor Agitation / Q000534:rehabilitation
chemical_list: D000700:Analgesics; D009020:Morphine; D003000:Clonidine
keywords: clonidine; morphine; neonatal abstinence syndrome; neurobehavioral manifestations; neurobehavioral scale; prenatal opiate exposure