6.2 million US children and adolescents have an asthma diagnosis and nearly half experience an asthma attack annually, which is responsible for significant healthcare utilization and costs. Opioids might worsen asthma symptom by directly causing bronchoconstriction or through central nervous system mediated effects such as analgesia and respiratory depression. The use of many prescription opioids are contraindicated in an unmonitored setting or in the absence of resuscitative equipment for patients with acute or severe bronchial asthma. Given that children may be more sensitive to the respiratory side effects associated with opioids, the FDA issued three additional contraindication warnings to specifically tighten the regulation on opioid use in children. Despite of these warnings, outpatient prescription opioid analgesics including codeine, hydrocodone, and tramadol use was found to be 58% to 77% higher in those with a diagnosis of asthma than for the general pediatric population, and nearly a half of these asthmatic children with opioid exposure have filled three or more opioid prescriptions. The incidence of adverse opioid effects for children with asthma during routine medical use remains unknown. A recent Food and Drug Administration advisory committee meeting stressed the need for data on outcomes in pediatric patients to support informed decision for pain management and protect children?s health. Guided by the conceptual framework of Andersen Behavioral Model (ABM), we proposed to assess the adverse drug effect of using opioids in children with asthma. We would also identify the provider and patient characteristics associated with this practice using the data from Texas Children?s Health Plan (TCHP), a large pediatric Managed Care Organization (MCO) that covers 400,000 Medicaid and CHIP enrolled children and adolescents. The proposed study has three specific aims:
Aim I : To assess the patient and prescriber characteristics associated with the use of prescription opioid analgesics versus alternative pharmacotherapies in children and adolescents, and to identify the unique risk factors associated with the contraindicated use of prescription opioids in those with active asthma.
Aim II : To examine the risk of asthma exacerbation associated with the use of prescription opioid analgesics.
Aim III : To identify the individual opioid analgesic associated with relatively lower risk of asthma exacerbation. Using a propensity score adjusted retrospective cohort design, we will test the Hypotheses that exposing children and adolescents to prescription opioid analgesics is associated with increased risk of asthma attack, measured as asthma-related emergency room visits or asthma-related hospitalizations. Of those exposed to opioid analgesics, the risk of having an asthma attack varies by the type of opioid (hydrocodone, tramadol, codeine) after controlling for opioid dosage and duration of action. This Innovative and Significant study is the first population based study that will quantify the risk associated with using prescription opioids in children with asthma. The risk, if verified as significant, will lead to an intervention that has the potential to change the existing practice paradigm and protect minors? safety.

Public Health Relevance

Asthma is a common chronic disease affecting millions of children and adolescents in the United States. The worsening of asthma symptoms often lead to emergency room visits, hospitalizations, and missed school and parent work days. The proposed study will examine whether exposing children with asthma to prescription opioids for cough or for pain will lead to asthma exacerbation, and also examine the patient and provider characteristics relevant to the practice. The findings will inform an important medication safety issue in children and will lead to interventions that have the potential to change providers? prescribing behaviors.

National Institute of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Small Research Grants (R03)
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Healthcare Effectiveness and Outcomes Research (HEOR)
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Perfetto, Deborah
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University of Houston
Schools of Pharmacy
United States
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