Clonidine versus phenobarbital as adjunctive therapy for neonatal abstinence syndrome. 2020

Carrie Brusseau, and Tara Burnette, and R Eric Heidel
Department of Pharmacy, University of Tennessee Medical Center, Knoxville, TN, USA. cbrussea@utmck.edu.

To compare clonidine versus phenobarbital as adjunctive therapy in infants who failed monotherapy with morphine for neonatal abstinence syndrome (NAS). Prospective, randomized, open-label study of infants ≥ 35 weeks' gestation. Infants received clonidine or phenobarbital per protocol. Primary outcome was morphine treatment days. Secondary outcomes were inpatient adjunctive days, length of stay (LOS), triple therapy, safety, and readmission rates. A total of 25 infants were treated with clonidine (n = 14) or phenobarbital (n = 11). Mean morphine treatment duration was significantly longer with clonidine (34.4 days, SD = 10.6) compared with phenobarbital (25.5 days, SD = 7.3, p = 0.026). The clonidine group also had higher inpatient adjunctive days (mean: 33.8 days [SD = 14.3] vs. 22 days [SD = 12.6], p = 0.042) and LOS (mean: 41.8 days [SD = 10.9] vs. 31 days [SD = 10]; p = 0.018) compared with phenobarbital. Phenobarbital, as adjunctive therapy, led to significantly shorter duration of morphine therapy, inpatient adjunctive days, and length of stay compared with clonidine.

UI MeSH Term Description Entries
D007231 Infant, Newborn An infant during the first 28 days after birth. Neonate,Newborns,Infants, Newborn,Neonates,Newborn,Newborn Infant,Newborn Infants
D007902 Length of Stay The period of confinement of a patient to a hospital or other health facility. Hospital Stay,Hospital Stays,Stay Length,Stay Lengths,Stay, Hospital,Stays, Hospital
D008691 Methadone A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3) Amidone,Biodone,Dolophine,Metadol,Metasedin,Methaddict,Methadone Hydrochloride,Methadose,Methex,Phenadone,Phymet,Physeptone,Pinadone,Symoron,Hydrochloride, Methadone
D009020 Morphine The principal alkaloid in opium and the prototype opiate analgesic and narcotic. Morphine has widespread effects in the central nervous system and on smooth muscle. Morphine Sulfate,Duramorph,MS Contin,Morphia,Morphine Chloride,Morphine Sulfate (2:1), Anhydrous,Morphine Sulfate (2:1), Pentahydrate,Oramorph SR,SDZ 202-250,SDZ202-250,Chloride, Morphine,Contin, MS,SDZ 202 250,SDZ 202250,SDZ202 250,SDZ202250,Sulfate, Morphine
D009357 Neonatal Abstinence Syndrome Fetal and neonatal addiction and withdrawal as a result of the mother's dependence on drugs during pregnancy. Withdrawal or abstinence symptoms develop shortly after birth. Symptoms exhibited are loud, high-pitched crying, sweating, yawning and gastrointestinal disturbances. Abstinence Syndrome, Neonatal,Neonatal Withdrawal Syndrome,Passive Addiction, Neonatal,Substance Withdrawal, Neonatal,Neonatal Substance Withdrawal,Abstinence Syndromes, Neonatal,Addiction, Neonatal Passive,Addictions, Neonatal Passive,Neonatal Abstinence Syndromes,Neonatal Passive Addiction,Neonatal Passive Addictions,Neonatal Substance Withdrawals,Neonatal Withdrawal Syndromes,Passive Addictions, Neonatal,Substance Withdrawals, Neonatal,Syndrome, Neonatal Abstinence,Syndrome, Neonatal Withdrawal,Syndromes, Neonatal Abstinence,Syndromes, Neonatal Withdrawal,Withdrawal Syndrome, Neonatal,Withdrawal Syndromes, Neonatal,Withdrawal, Neonatal Substance
D010634 Phenobarbital A barbituric acid derivative that acts as a nonselective central nervous system depressant. It potentiates GAMMA-AMINOBUTYRIC ACID action on GABA-A RECEPTORS, and modulates chloride currents through receptor channels. It also inhibits glutamate induced depolarizations. Phenemal,Phenobarbitone,Phenylbarbital,Gardenal,Hysteps,Luminal,Phenobarbital Sodium,Phenobarbital, Monosodium Salt,Phenylethylbarbituric Acid,Acid, Phenylethylbarbituric,Monosodium Salt Phenobarbital,Sodium, Phenobarbital
D011446 Prospective Studies Observation of a population for a sufficient number of persons over a sufficient number of years to generate incidence or mortality rates subsequent to the selection of the study group. Prospective Study,Studies, Prospective,Study, Prospective
D003000 Clonidine An imidazoline sympatholytic agent that stimulates ALPHA-2 ADRENERGIC RECEPTORS and central IMIDAZOLINE RECEPTORS. It is commonly used in the management of HYPERTENSION. Catapres,Catapresan,Catapressan,Chlophazolin,Clofelin,Clofenil,Clonidine Dihydrochloride,Clonidine Hydrochloride,Clonidine Monohydrobromide,Clonidine Monohydrochloride,Clopheline,Dixarit,Gemiton,Hemiton,Isoglaucon,Klofelin,Klofenil,M-5041T,ST-155,Dihydrochloride, Clonidine,Hydrochloride, Clonidine,M 5041T,M5041T,Monohydrobromide, Clonidine,Monohydrochloride, Clonidine,ST 155,ST155
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000701 Analgesics, Opioid Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. Opioid,Opioid Analgesic,Opioid Analgesics,Opioids,Full Opioid Agonists,Opioid Full Agonists,Opioid Mixed Agonist-Antagonists,Opioid Partial Agonists,Partial Opioid Agonists,Agonist-Antagonists, Opioid Mixed,Agonists, Full Opioid,Agonists, Opioid Full,Agonists, Opioid Partial,Agonists, Partial Opioid,Analgesic, Opioid,Full Agonists, Opioid,Mixed Agonist-Antagonists, Opioid,Opioid Agonists, Full,Opioid Agonists, Partial,Opioid Mixed Agonist Antagonists,Partial Agonists, Opioid

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