Trial reportArchives of disease in childhood. Fetal and neonatal edition2004
A randomised controlled trial of morphine versus phenobarbitone for neonatal abstinence syndrome.
Trial report in Archives of disease in childhood. Fetal and neonatal edition, 2004. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 108 citations in OpenAlex.
- Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021Pooled it
- Maintenance agonist treatments for opiate-dependent pregnant women.The Cochrane database of systematic reviews · 2020Pooled it
- Therapeutic approaches for neonatal abstinence syndrome: a systematic review of randomized clinical trials.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2019Pooled it
- Pharmacological Treatments for Neonatal Abstinence Syndrome: A Systematic Review and Network Meta-analysis.JAMA pediatrics · 2019Pooled it
- Review of the assessment and management of neonatal abstinence syndrome.Addiction science & clinical practice · 2014Pooled it
- Accelerated Weaning of Opioids to Reduce Pharmacologic Exposure for Neonatal Opioid Withdrawal Syndrome: A Randomized Clinical Trial.The Journal of pediatrics · 2026Trial
- Trial
- Treatment of opioid withdrawal in neonates with morphine, phenobarbital, or chlorpromazine: a randomized double-blind trial.European journal of pediatrics · 2020Trial
- Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a randomized control trial.BMC pediatrics · 2015Trial
- Revised dose schema of sublingual buprenorphine in the treatment of the neonatal opioid abstinence syndrome.Addiction (Abingdon, England) · 2011Trial
- Sublingual buprenorphine for treatment of neonatal abstinence syndrome: a randomized trial.Pediatrics · 2008Trial
- Neonatal Abstinence Syndrome and Corresponding Pharmacotherapy Approaches from 2 University-affiliated Neonatal Intensive Care Units in Puerto Rico (2018-2020).Puerto Rico health sciences journal · 2024Article
- Use of Phenobarbital to Treat Neonatal Abstinence Syndrome From Exposure to Single vs. Multiple Substances.Frontiers in pediatrics · 2021Article
- Neonatal abstinence syndrome: an update.Current opinion in pediatrics · 2018Review
- Neonatal Adaptation Issues After Maternal Exposure to Prescription Drugs: Withdrawal Syndromes and Residual Pharmacological Effects.Drug safety · 2016Review
- Neonatal abstinence syndrome: Pharmacologic strategies for the mother and infant.Seminars in perinatology · 2016Review
- Population Pharmacokinetic Model of Sublingual Buprenorphine in Neonatal Abstinence Syndrome.Pharmacotherapy · 2015Article
- A multicenter cohort study of treatments and hospital outcomes in neonatal abstinence syndrome.Pediatrics · 2014Article
- Neonatal abstinence syndrome: essentials for the practitioner.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2014Review
- Pharmacologic management of the opioid neonatal abstinence syndrome.Pediatric clinics of North America · 2012Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe incidence of neonatal abstinence syndrome (NAS) has increased 10-fold over the last decade in Glasgow. In the Princess Royal Maternity Hospital, it now accounts for 17% of special care baby unit (SCBU) admissions.
objectiveTo compare opiate replacement therapy (morphine sulphate) with the present standard treatment (phenobarbitone) for management of NAS. The primary study end point was duration of pharmaceutical treatment. Secondary end points were the requirement for additional drugs and the requirement for SCBU admission.
designDouble blind, randomised controlled clinical trial.
methodsDifferential diagnoses were excluded, and two consecutive Lipsitz scores > 4 defined NAS requiring treatment. Infants were randomised to receive morphine sulphate or phenobarbitone. Treatments were identical in appearance, odour, and volume. Increments, decrements, and discontinuation of treatments were protocol driven.
resultsSeventy five infants participated. All mothers received opiate replacement therapy (methadone) during pregnancy and most used other drugs (n = 62, 83%). No significant difference in maternal drug use patterns was observed between treatment groups. Median treatment duration was four days shorter with opiate replacement (8 v 12 days, Mann-Whitney U test, p = 0.02). Phenobarbitone treated infants tended to require second line treatment (47% v 35%, chi(2) test, p = 0.11) and SCBU admission (62% v 30%, chi(2) test, p = 0.04) more often.
conclusionsOpiate replacement therapy appears to be superior for management of symptomatic NAS when maternal opiate use is prevalent. The shorter treatment duration and lower requirement for higher intensity nursing may have significant cost implications. Tailoring NAS treatment to local maternal drug use may result in similar benefits.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.