Evidence map›Paper›PMID 25976238›Full record

Trial reportBMC pediatrics2015

Phenobarbital versus morphine in the management of neonatal abstinence syndrome, a randomized control trial.

Fatemeh Nayeri, Mahdi Sheikh, Majid Kalani, Pedram Niknafs, Mamak Shariat, Hosein Dalili, Ahmad-Reza Dehpour

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC pediatrics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 4 pooled it
4.6field-weighted citation impact, top 6% of its field
1 · What the graph read from 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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 4 syntheses or guidelines pooled it, 35 citations in OpenAlex.

  1. Opioid treatment for opioid withdrawal in newborn infants.The Cochrane database of systematic reviews · 2021
    Pooled it
  2. Pooled it
  3. Therapeutic approaches for neonatal abstinence syndrome: a systematic review of randomized clinical trials.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2019
    Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Neonatal Abstinence Syndrome Practices in the United States.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2021
    Article
  13. Article
  14. Review
  15. Review
  16. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 3 institutions in 1 country.

Fatemeh NayeriMaternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran. fnayeri@sina.tums.ac.ir.
Mahdi SheikhMaternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran. mahdisheikh@gmail.com.
Majid KalaniDepartment of Neonatology, Akbar-Abadi Hospital, Iran University of Medical Sciences, Tehran, Iran. mahduni@icloud.com.
Pedram NiknafsPediatrics Department, Kerman University of Medical Sciences, Kerman, Iran. Pniknaffs@yahoo.com.
Mamak ShariatMaternal, Fetal and Neonatal Research Center, Tehran University of Medical Sciences, Tehran, Iran. mshariat@tums.ac.ir.
Hosein DaliliBreastfeeding Research Center, Tehran University of Medical Sciences, Tehran, Iran. hoseindalili@yahoo.com.
Ahmad-Reza DehpourDepartment of Pharmacology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran. dehpour@medscape.com.
Tehran University of Medical Sciences · IRIran University of Medical Sciences · IRKerman University of Medical Sciences · IR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundsEvaluating the efficacy of the loading and tapering dose of Phenobarbital versus oral Morphine in the management of NAS.

methodsThis randomized, open-label, controlled trial was conducted on 60 neonates born to illicit drugs dependent mothers at Vali-Asr and Akbar-Abadi hospitals, Tehran, Iran, who exhibited NAS requiring medical therapy. The neonates were randomized to receive either: Oral Morphine Sulfate or a loading dose of Phenobarbital followed by a tapering dose. The duration of treatment required for NAS resolution, the total hospital stay and the requirement for additional second line treatment were compared between the treatment groups.

resultsThe Mean ± Standard Deviation for the duration of treatment required for the resolution of NAS was 8.5 ± 5 days in the Morphine group and 8.5 ± 4 days in the Phenobarbital group (P = 0.9). The duration of total hospital stay was 12.6 ± 5.6 days in the Morphine group and 12.5 ± 5.3 days in the Phenobarbital group (P = 0.7). 3.3 % in the Morphine group versus 6.6 % in the Phenobarbital group required adjunctive treatment (P = 0.5).

conclusionsThere were no significant differences in the duration of treatment, duration of hospital stay, and the requirement for adjunctive treatment, between the neonates with NAS who received Morphine Sulfate and neonates who received a loading and tapering dose of Phenobarbital.

trial registrationThis study is registered at the Iranian Registry of Clinical Trials ( www.irct.ir ) which is a Primary Registry in the WHO Registry Network. (Registration Number =  IRCT201406239568N8 ).

Indexed as

Administration, OralAnalgesics, OpioidChemotherapy, AdjuvantDrug Administration ScheduleHumansHypnotics and SedativesInfant, NewbornIranLength of StayMorphineNeonatal Abstinence SyndromePhenobarbitalProspective StudiesTreatment OutcomeAnalgesics, OpioidHypnotics and SedativesMorphinePhenobarbital

Identifiers

PMID25976238
PMCPMC4438473
OpenAlexW1494712648

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.