Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial.

Three suitable compounds (morphine, chlorpromazine, and phenobarbital) to treat neonatal abstinence syndrome were compared in a prospective multicenter, double-blind trial. Neonates exposed to opioids in utero were randomly allocated to one of three treatment groups. When a predefined threshold of a...

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Publicado en:European Journal of Pediatrics Vol. 179; no. 1; pp. 141 - 150
Autores principales: Zimmermann, Urs, Rudin, Christoph, Duò, Angelo, Held, Leonhard, Bucher, Hans Ulrich
Formato: research randomized controlled trial Journal Article
Publicado: Springer Nature Jan2020
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Jan2020
      vid: 179
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      pub: Springer Nature
      place: New York, New York
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        atl: Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial.
      aug:
        au:
          Zimmermann, Urs
          Rudin, Christoph
          Duò, Angelo
          Held, Leonhard
          Bucher, Hans Ulrich
        affil: Department of Neonatology, Spital Bülach, CH–8180, Bülach, Switzerland
      sug:
        subj:
          Morphine Therapeutic Use
          Phenobarbital Therapeutic Use
          Hypnotics and Sedatives Therapeutic Use
          Neonatal Abstinence Syndrome Drug Therapy
          Chlorpromazine Therapeutic Use
          Dopamine Antagonists Therapeutic Use
          Analgesics, Opioid Adverse Effects
          Dose-Response Relationship, Drug
          Human
          Prospective Studies
          Analgesics, Opioid Therapeutic Use
          Infant, Newborn
          Drug Therapy, Combination
          Double-Blind Studies
          Treatment Outcomes
          Female
          Male
          Drug Administration Schedule
          Validation Studies
          Comparative Studies
          Evaluation Research
          Multicenter Studies
          Randomized Controlled Trials
          Infant, Newborn: birth-1 month
          Female
          Male
      ab: Three suitable compounds (morphine, chlorpromazine, and phenobarbital) to treat neonatal abstinence syndrome were compared in a prospective multicenter, double-blind trial. Neonates exposed to opioids in utero were randomly allocated to one of three treatment groups. When a predefined threshold of a modified Finnegan score was reached, treatment started and increased stepwise until symptoms were controlled. If symptoms could not be controlled with the predefined maximal dose of a single drug, a second drug was added. Among 143 infants recruited, 120 needed pharmacological treatment. Median length of treatment for morphine was 22 days (95% CI 18 to 33), for chlorpromazine 25 days (95% CI 21 to 34), and for phenobarbital 32 days (95% CI 27 to 38) (p = ns). In the morphine group, only 3% of infants (1/33) needed a second drug; in the chlorpromazine group, this proportion was 56% (24/43), and in the phenobarbital group 30% (13/44).Conclusion: None of the drugs tested for treating neonatal abstinence syndrome resulted in a significantly shorter treatment length than the others. As morphine alone was able to control symptoms in almost all infants, it may be preferred to the two other drugs but should still be tested against more potent opioids such as buprenorphine.Trial registration: At ClinicalTrials.gov NCT02810782 (registered retrospectively).What is Known:• Neonates exposed to opiates in utero and presenting with withdrawal symptoms should first be treated by non-pharmacological supportive measures.• In those who fail, drugs have to be given, but there is controversy which drug is best.What is New:• Among three candidates, morphine, chlorpromazine and phenobarbital, none resulted in significantly shorter treatment time.• As morphine alone was able to control symptoms in almost all infants, it may be preferred to the two other drugs.
      pubtype: Academic Journal
      doctype:
        research
        randomized controlled trial
        Journal Article
      ougenre: Article
    language: English
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