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American Academy of Pediatrics
Article

Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome

Stephanie L. Merhar, Songthip Ounpraseuth, Lori A. Devlin, Brenda B. Poindexter, Leslie W. Young, Sean D. Berkey, Moira Crowley, Adam J. Czynski, Autumn S. Kiefer, Bonny L. Whalen, Abhik Das, Janell F. Fuller, Rosemary D. Higgins, Vaishali Thombre, Barry M. Lester, P. Brian Smith, Sarah Newman, Pablo J. Sánchez, M. Cody Smith, Alan E. Simon and FOR THE EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT NEONATAL RESEARCH NETWORK AND THE NIH ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES (ECHO) PROGRAM INSTITUTIONAL DEVELOPMENT AWARDS STATES PEDIATRIC CLINICAL TRIALS NETWORK
Pediatrics March 2021, 147 (3) e2020017830; DOI: https://doi.org/10.1542/peds.2020-017830
Stephanie L. Merhar
aPerinatal Institute, Division of Neonatology, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio and Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio;
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Songthip Ounpraseuth
bDepartment of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas;
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Lori A. Devlin
cDepartment of Pediatrics, University of Louisville, Louisville, Kentucky;
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Brenda B. Poindexter
aPerinatal Institute, Division of Neonatology, Cincinnati Children’s Hospital Medical Center, Cincinnati, Ohio and Department of Pediatrics, University of Cincinnati, Cincinnati, Ohio;
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Leslie W. Young
dLarner College of Medicine at the University of Vermont, Burlington, Vermont;
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Sean D. Berkey
eAlaska Native Tribal Health Consortium, Anchorage, Alaska;
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Moira Crowley
fRainbow Babies and Children’s Hospital, Cleveland, Ohio;
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Adam J. Czynski
gDepartment of Pediatrics, Women and Infant’s Hospital, Providence, Rhode Island;
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Autumn S. Kiefer
hDepartment of Pediatrics, West Virginia University School of Medicine, Morgantown, West Virginia;
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Bonny L. Whalen
iChildren’s Hospital at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire;
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Abhik Das
jRTI International, Rockville, Maryland;
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Janell F. Fuller
kUniversity of New Mexico Health Sciences Center, Albuquerque, New Mexico;
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Rosemary D. Higgins
lNational Institute of Child Health and Human Development, Bethesda, Maryland and George Mason University, Fairfax, Virginia;
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Vaishali Thombre
bDepartment of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, Arkansas;
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Barry M. Lester
mCenter for the Study of Children at Risk, Department of Pediatrics, Brown Alpert Medical School and Women and Infants Hospital, Providence, Rhode Island;
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P. Brian Smith
nDuke Clinical Research Institute, School of Medicine, Duke University, Durham, North Carolina;
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Sarah Newman
oNebraska Medical Center, Omaha, Nebraska;
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Pablo J. Sánchez
pNationwide Children’s Hospital, College of Medicine, The Ohio State University, Columbus, Ohio;
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M. Cody Smith
qDepartment of Pediatrics, School of Medicine, West Virginia University, Morgantown, West Virginia; and
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Alan E. Simon
rEnvironmental Influences on Child Health Outcomes Program, Office of the Director, National Institutes of Health, Rockville, Maryland
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Abstract

BACKGROUND AND OBJECTIVES: Despite the neonatal opioid withdrawal syndrome (NOWS) epidemic in the United States, evidence is limited for pharmacologic management when first-line opioid medications fail to control symptoms. The objective with this study was to evaluate outcomes of infants receiving secondary therapy with phenobarbital compared with clonidine, in combination with morphine, for the treatment of NOWS.

METHODS: We performed a retrospective cohort study of infants with NOWS from 30 hospitals. The primary outcome measures were the length of hospital stay, duration of opioid treatment, and peak morphine dose. Outcomes were compared by group by using analysis of variance and multivariable linear regression controlling for relevant confounders.

RESULTS: Of 563 infants with NOWS treated with morphine, 32% (n = 180) also received a secondary medication. Seventy-two received phenobarbital and 108 received clonidine. After adjustment for covariates, length of hospital stay was 10 days shorter, and, in some models, duration of morphine treatment was 7.5 days shorter in infants receiving phenobarbital compared with those receiving clonidine, with no difference in peak morphine dose. Infants were more likely to be discharged from the hospital on phenobarbital than clonidine (78% vs 29%, P < .0001).

CONCLUSIONS: Among infants with NOWS receiving morphine and secondary therapy, those treated with phenobarbital had shorter length of hospital stay and shorter morphine treatment duration than clonidine-treated infants but were discharged from the hospital more often on secondary medication. Further investigation is warranted to determine if the benefits of shorter hospital stay and shorter duration of morphine therapy justify the possible neurodevelopmental consequences of phenobarbital use in infants with NOWS.

  • Accepted December 4, 2020.
  • Copyright © 2021 by the American Academy of Pediatrics

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Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome
Stephanie L. Merhar, Songthip Ounpraseuth, Lori A. Devlin, Brenda B. Poindexter, Leslie W. Young, Sean D. Berkey, Moira Crowley, Adam J. Czynski, Autumn S. Kiefer, Bonny L. Whalen, Abhik Das, Janell F. Fuller, Rosemary D. Higgins, Vaishali Thombre, Barry M. Lester, P. Brian Smith, Sarah Newman, Pablo J. Sánchez, M. Cody Smith, Alan E. Simon, FOR THE EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT NEONATAL RESEARCH NETWORK AND THE NIH ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES (ECHO) PROGRAM INSTITUTIONAL DEVELOPMENT AWARDS STATES PEDIATRIC CLINICAL TRIALS NETWORK
Pediatrics Mar 2021, 147 (3) e2020017830; DOI: 10.1542/peds.2020-017830

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Phenobarbital and Clonidine as Secondary Medications for Neonatal Opioid Withdrawal Syndrome
Stephanie L. Merhar, Songthip Ounpraseuth, Lori A. Devlin, Brenda B. Poindexter, Leslie W. Young, Sean D. Berkey, Moira Crowley, Adam J. Czynski, Autumn S. Kiefer, Bonny L. Whalen, Abhik Das, Janell F. Fuller, Rosemary D. Higgins, Vaishali Thombre, Barry M. Lester, P. Brian Smith, Sarah Newman, Pablo J. Sánchez, M. Cody Smith, Alan E. Simon, FOR THE EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT NEONATAL RESEARCH NETWORK AND THE NIH ENVIRONMENTAL INFLUENCES ON CHILD HEALTH OUTCOMES (ECHO) PROGRAM INSTITUTIONAL DEVELOPMENT AWARDS STATES PEDIATRIC CLINICAL TRIALS NETWORK
Pediatrics Mar 2021, 147 (3) e2020017830; DOI: 10.1542/peds.2020-017830
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