Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial

Surran, B; Visintainer, Paul; Chamberlain, Stacey; Kopcza, Kathleen; Shah, Bhavesh; Singh, Rachana

doi:10.1038/jp.2013.95

Cited by 72 publications

(59 citation statements)

References 29 publications

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“…45 However, these studies combined clonidine with morphine, and the concern for potential detrimental effects of continuing postnatal opiate exposure remains. 27 We observed a longer duration of treatment than those reported in combination therapy 25,45 ; this outcome may be related to the single-drug therapy. In addition, the dose for this study is at the lower end reported in the literature, especially for clonidine.…”

Section: Discussionmentioning

confidence: 99%

“…25,26,45 Clonidine as adjunctive therapy for NAS was associated with a decrease in the number of morphine doses, duration of treatment, or length of hospital stay. 25,45 From a recent randomized trial, clonidine given with morphine resulted in a shorter duration of therapy compared with the morphine and phenobarbital combination. 45 However, these studies combined clonidine with morphine, and the concern for potential detrimental effects of continuing postnatal opiate exposure remains.…”

Section: Discussionmentioning

confidence: 99%

“…25,45 From a recent randomized trial, clonidine given with morphine resulted in a shorter duration of therapy compared with the morphine and phenobarbital combination. 45 However, these studies combined clonidine with morphine, and the concern for potential detrimental effects of continuing postnatal opiate exposure remains. 27 We observed a longer duration of treatment than those reported in combination therapy 25,45 ; this outcome may be related to the single-drug therapy.…”

Section: Discussionmentioning

confidence: 99%

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Morphine Versus Clonidine for Neonatal Abstinence Syndrome

Bada¹,

Sithisarn²,

Gibson

et al. 2015

Pediatrics

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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 mg/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 mg/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. WHAT'S KNOWN ON THIS SUBJECT:Increased central adrenergic activity occurs with opiate withdrawal. Clonidine is an effective drug as an adjunct to morphine in the treatment of neonatal abstinence syndrome. It is unclear whether clonidine is effective as single-drug therapy.WHAT THIS STUDY ADDS: Clonidine, a a 2 -adrenergic agonist, seems to be as effective as morphine when used as a single-drug therapy for neonatal abstinence syndrome. Its administration results in improvement in neurobehavioral performance.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Morphine Versus Clonidine for Neonatal Abstinence Syndrome

Bada¹,

Sithisarn²,

Gibson

et al. 2015

Pediatrics

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show abstract

“…Several studies yielded contradictory results in evaluating the efficacy of adjunctive treatment with phenobarbital and clonidine; however, a 2010 Cochrane Review of six studies concluded that addition of phenobarbital or clonidine may reduce duration of treatment for NAS 63. These medications have also been compared directly to one another (in combination with morphine) 64. Surran et al 64 found that infants receiving adjunctive treatment with phenobarbital had a shorter duration of hospitalisation than those adjunctively treated with clonidine, notably, however, infants were discharged home on phenobarbital resulting in a much longer duration of treatment.…”

Section: Neonatal Managementmentioning

confidence: 99%

“…These medications have also been compared directly to one another (in combination with morphine) 64. Surran et al 64 found that infants receiving adjunctive treatment with phenobarbital had a shorter duration of hospitalisation than those adjunctively treated with clonidine, notably, however, infants were discharged home on phenobarbital resulting in a much longer duration of treatment.…”

Section: Neonatal Managementmentioning

confidence: 99%

The opioid epidemic and neonatal abstinence syndrome in the USA: a review of the continuum of care

Pryor

Maalouf

Krans

et al. 2017

Arch Dis Child Fetal Neonatal Ed

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As the prescription opioid epidemic grew in the USA, its impact extended to pregnant women and their infants. This review summarises how increasing rates of neonatal abstinence syndrome resulted in a need to improve care to pregnant women and opioid-exposed infants. We discuss the variations in care delivery with particular emphasis on screening at-risk mothers, scoring systems for neonatal drug withdrawal, type and duration of pharmacotherapy, and discharge safety.

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Neonatal Abstinence Syndrome

Wachman

Schiff

Silverstein

2018

JAMA

165

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Evidence pertaining to the optimal diagnosis and treatment strategies for neonatal abstinence syndrome is based on small or low-quality studies that focus on intermediate outcomes, such as need for pharmacologic treatment or length of hospital stay. Clinical trials are needed to evaluate health and neurodevelopmental outcomes associated with objective diagnostic approaches as well as pharmacologic and nonpharmacologic treatment modalities.

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Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial

Abstract: Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.

Cited by 72 publications

References 29 publications

Morphine Versus Clonidine for Neonatal Abstinence Syndrome

Morphine Versus Clonidine for Neonatal Abstinence Syndrome

The opioid epidemic and neonatal abstinence syndrome in the USA: a review of the continuum of care

Neonatal Abstinence Syndrome

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