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Tramadol Use in Pediatric Surgery: Trends After the Food and Drug Administration Black-Box Warning

Stephanie Y Chen1, Shadassa Ourshalimian1, Eugene Kim2

  • 1Division of Pediatric Surgery, Children's Hospital Los Angeles, Los Angeles, California.

The Journal of Surgical Research
|August 9, 2022
PubMed

Insights

Despite a 2017 FDA black-box warning, perioperative tramadol use in children under 12 continues. Factors like sex, age, and comorbidities influence prescribing, necessitating interventions to reduce its use in pediatric surgery.

Area of Science:

  • Pediatric Surgery
  • Pharmacology
  • Public Health

Background:

  • The U.S. Food and Drug Administration (FDA) issued a black-box warning in 2017, contraindicating tramadol in children younger than 12 years.
  • Longitudinal trends and factors influencing perioperative tramadol use in pediatric surgical patients remained unclear following the warning.

Purpose of the Study:

  • To evaluate temporal trends in perioperative tramadol use in children after the FDA's 2017 black-box warning.
  • To identify patient and institutional factors associated with tramadol use in pediatric surgical patients.

Main Methods:

  • A retrospective, multi-institutional cohort study was conducted using the Pediatric Health Information System database.
  • Data included children aged 2-18 years who underwent one of ten common surgeries between January 2009 and February 2020.
  • Hierarchical multivariable logistic regression analysis was used to identify factors associated with tramadol use.

Main Results:

  • Of 477,153 children, 1.2% received tramadol. Post-warning, 16.1% of tramadol recipients were under 12 years old.
  • Tramadol use in children under 12 decreased from 1.87% in 2016 to 0.66% in 2019.
  • Factors increasing tramadol likelihood included female sex, age ≥12 years, Midwest location, and specific comorbidities (gastrointestinal, metabolic, transplant-related). Hispanic/Latino ethnicity and public insurance were associated with decreased use.

Conclusions:

  • Tramadol prescribing persists in children under 12 undergoing surgery, despite the FDA contraindication.
  • Patient demographics, comorbidities, and institutional factors significantly influence perioperative tramadol use.
  • Interventions are necessary to further reduce the use of tramadol in pediatric surgical patients.
Abstract

Keywords:
OpioidPainPediatric surgeryTramadol

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