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Effect of Mirtazapine on Nausea in Children with Functional Nausea and Functional Dyspepsia Postprandial Distress Syndrome

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Abstract

Objective

The objective of this study was to assess the clinical response and safety of mirtazapine in the pediatric population with a diagnosis of functional nausea and nausea associated with functional dyspepsia postprandial distress syndrome.

Methods

This was a retrospective chart review to evaluate the safety and efficacy of mirtazapine for pediatric nausea and nausea associated with functional dyspepsia postprandial distress syndrome. Clinical response was classified as complete response, partial response, and no response. We also identified the prescribed doses, side effects, and weight changes during mirtazapine therapy.

Results

Among the 57 total patients, 67% were females and ages ranged from 7 to 19 years with a mean of 14 ± 3 years. Clinical (complete and partial) response was reported in 82% of patients. Nausea resolved in 82% and insomnia in 77% of the patients. Eighty-four percent gained weight with a mean of 4 ± 7 kg. Sixty-five percent did not report adverse effects. The most common adverse effects were undesired weight gain (16%) and dysphoria (9%). Two patients discontinued the medicine after the first dose because of adverse effects. There was a significant correlation between the initial dose and weight (rs = 0.478; p = 0.0002). The median initial and final doses were 15 mg, respectively.

Conclusions

Mirtazapine is an option for treating children and adolescents with functional nausea and nausea associated with functional dyspepsia post-prandial distress syndrome, especially for a select group of patients with concurrent weight loss, anxiety, and insomnia.

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Author information

Authors and Affiliations

  1. Department of Pediatric Gastroenterology, Hepatology, and Nutrition of LSU Health Sciences Center New Orleans, New Orleans, LA, USA

    Ivonne M. Iglesias-Escabi, Colleen LeBlanc & Paul E. Hyman

  2. Children’s Hospital of New Orleans, New Orleans, LA, USA

    Ivonne M. Iglesias-Escabi, Erin Reuther, Colleen LeBlanc & Paul E. Hyman

  3. Division of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA

    David Kleesattel & Neha R. Santucci

  4. Department of LSU School of Public Health of New Orleans, New Orleans, LA, USA

    Lee S. McDaniel

  5. Division of Pediatric Gastroenterology, Hepatology, and Nutrition, Cincinnati Children’s Hospital Center, Suite T8.382, 3333 Burnet Ave, Cincinnati, OH, 45229, USA

    Neha R. Santucci

Authors
  1. Ivonne M. Iglesias-Escabi
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  2. David Kleesattel
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  3. Lee S. McDaniel
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  4. Erin Reuther
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  5. Colleen LeBlanc
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  6. Paul E. Hyman
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  7. Neha R. Santucci
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Corresponding author

Correspondence to Neha R. Santucci.

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Funding

None.

Conflicts of interest/Competing interests

There is no financial disclosure or conflicts of interests.

Availability of data and material

Available upon request

Code availability

Not applicable

Ethics approval

LSU: #10116, date: 7-30-2018; CCHMC: #00002988, date: 7-30-2018

Consent to participate

Consent waivered for retrospective chart review

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Consent available

Authors' contributions

Dr. Iglesias-Escabi wrote the IRB proposal, reviewed charts, collected data, interpreted the collected data, and wrote the first draft of the manuscript with input from Dr. Santucci, Dr. Hyman, and Dr. LeBlanc. Dr. McDaniel performed statistical analysis for the study.Dr. Reuther provided psychology feedback, critically review the study proposal, drafted and revised the manuscript. Dr. Kleesattel reviewed charts, collected data, performed literature search and revised the manuscript. Dr. LeBlanc assisted in graphs and tables, drafted and revised the research work. (Late) Dr. Hyman conceptualized the study, provided feedback on study design, and contributed to revision of the manuscript. Dr. Santucci conceptualized the study, provided framework for study design, supervised and mentored Dr. Iglesias to prepare the manuscript and revised each iteration of the manuscript.

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Iglesias-Escabi, I.M., Kleesattel, D., McDaniel, L.S. et al. Effect of Mirtazapine on Nausea in Children with Functional Nausea and Functional Dyspepsia Postprandial Distress Syndrome. Pediatr Drugs 24, 155–161 (2022). https://doi.org/10.1007/s40272-022-00494-2

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  • DOI: https://doi.org/10.1007/s40272-022-00494-2

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