Evidence map›Paper›PMID 34037761›Full record

ArticleJournal of analytical toxicology2021

Neonatal Exposure to Tramadol through Mother's Breast Milk.

Ashley M Gesseck, Michelle R Peace, Carrol R Nanco, Carl E Wolf, Karen D Hendricks-Muñoz, Jie Xu, Justin L Poklis

Abstract read
In one paragraph

Article in Journal of analytical toxicology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
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

1 citing paper in PubMed.

  1. 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.

Ashley M GesseckIntegrative Life Sciences Doctoral Program, Virginia Commonwealth University, 1000 W Cary St, Richmond, VA 23284, USA.ORCID 0000-0002-3400-5745
Michelle R PeaceDepartment of Forensic Science, Virginia Commonwealth University, 1015 Floyd Ave, Richmond, VA 23284, USA.
Carrol R NancoDepartments of Pathology, Virginia Commonwealth University, 1001 E Marshall St, Richmond, VA 23284, USA.
Carl E WolfDepartments of Pathology, Virginia Commonwealth University, 1001 E Marshall St, Richmond, VA 23284, USA.
Karen D Hendricks-MuñozDivision of Neonatal Medicine, Department of Pediatrics, Children's Hospital of Richmond at VCU, School of Medicine, Virginia Commonwealth University, 1000 E Broad St, Richmond, VA 23284, USA.
Jie XuDivision of Neonatal Medicine, Department of Pediatrics, Children's Hospital of Richmond at VCU, School of Medicine, Virginia Commonwealth University, 1000 E Broad St, Richmond, VA 23284, USA.
Justin L PoklisDepartments of Pharmacology and Toxicology, Virginia Commonwealth University, 1112 E Clay St, Richmond, VA 23284, USA.ORCID 0000-0001-5470-5717

Funding

VCU Center for Drug Addiction ResearchP30DA033934 · NIDA · VIRGINIA COMMONWEALTH UNIVERSITY · PI YAN ZHANG · 2014 to 2026
$13.8M
NIDA NIH HHS P30 DA033934NIH HHS [P30DA033934]
6 · The paper itself

Abstract

Tramadol is an opioid used in the treatment of moderate to moderately severe pain. Tramadol's use during pregnancy is generally avoided and may cause some reversible withdrawal effects in neonates, and its use during lactation is not licensed by the manufacturer. A small clinical trial reported infants were exposed to <3% of a mother's tramadol dose through breast milk with no evidence of harmful effects. Presented is a case study of breast milk, neonatal urine, and neonatal oral fluid for the analysis of tramadol and its metabolites, along with the validation of a method for the analysis of tramadol, O-desmethyltramadol, and N-desmethyltramadol in breast milk. Tramadol and its metabolites were extracted by solid-phase extraction after saponification of breast milk to remove lipids. Samples were analyzed by ultra-pressure liquid chromatography-tandem mass spectrometry. To the author's knowledge, this is the first report of tramadol and its metabolites in neonatal oral fluid. The breast milk concentrations were 63, 22, and 76 ng/mL for the analysis of tramadol, O-desmethyltramadol, and N-desmethyltramadol, respectively, on day of life 12. On day of life 20, the breast milk concentrations were 1,254, 388, and 937 ng/mL for the analysis of tramadol, O-desmethyltramadol, and N-desmethyltramadol, respectively. Oral fluid concentrations were 1,011, 1,499, and 406 ng/mL for the analysis of tramadol, O-desmethyltramadol, and N-desmethyltramadol, respectively, on day of life 20. Oral fluid concentrations were similar to breast milk for tramadol, almost four times higher for O-desmethyltramadol, and less than half for N-desmethyltramadol. The absolute infant dose was calculated to be 10 μg/kg/day and 294 μg/kg/day for tramadol on day of life 12 and 20, respectively.

Indexed as

TramadolAnalgesics, OpioidChromatography, LiquidFemaleHumansInfant, NewbornMilk, HumanMothersPregnancyAnalgesics, OpioidTramadol

Identifiers

PMID34037761
PMCPMC8446644

What OpenQuestion holds

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Registered trials

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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.