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Change in Pediatric Adenotonsillectomy Postoperative Visit Patterns After Opioid Food and Drug Administration Warning
Naiomi Cohen1, Kathryn Schissler2, Justin Jeter3
1From the Department of Pediatric Emergency Medicine, Nicklaus Children's Hospital, Miami, FL.
Insights
Opioid prescriptions after tonsillectomy and adenoidectomy (T+A) correlate with increased pain-related visits. The FDA black box warning, however, reduced opioid use and associated return visits, suggesting unintended benefits in pediatric pain management.
Area of Science:
- Pediatric Otolaryngology
- Pain Management
- Pharmacovigilance
Background:
- Tonsillectomy with adenoidectomy (T+A) is a common pediatric procedure.
- Postoperative pain management is critical, with opioids historically being a primary treatment.
- Concerns exist regarding the safety and efficacy of opioid use in children.
Purpose of the Study:
- To investigate the association between opioid prescriptions and pain-related return visits after pediatric T+A.
- To evaluate the impact of the Food and Drug Administration (FDA) black box warning on opioid use and return visit rates.
Main Methods:
- Retrospective cohort study of 4778 pediatric patients undergoing T+A.
- Analysis of return visits to emergency or urgent care.
- Multivariate logistic regression to assess associations between opioid prescriptions, FDA warning, and return visits, adjusting for confounders.
Main Results:
- Opioid prescriptions were linked to a higher incidence of pain-related return visits (adjusted OR, 1.31).
- Following the FDA black box warning, opioid prescribing decreased significantly (47.9% vs. 98.6%).
- Pain-related return visits decreased post-warning (OR, 0.73), with a notable increase in steroid prescriptions.
Conclusions:
- Opioid use after T+A is associated with increased pain-related return visits in pediatric patients.
- The FDA black box warning appears to have reduced opioid prescriptions and associated return visits.
- The warning may have led to unintended positive outcomes in pediatric pain management and healthcare utilization.
Study Objective:
This study aimed to determine the association between opioid prescriptions given after tonsillectomy with adenoidectomy (T + A) and pain-related return visit rates in pediatric patients. Determine association between Food and Drug Administration (FDA) black box warning against opioid use in this population and pain-related return visit rates.
Methods:
This was a single-institution retrospective cohort study of pediatric patients who underwent T + A between April 2012 and December 2015 and had return visits to the emergency department or urgent care center. Data were obtained from the hospital electronic warehouse using International Classification of Diseases-9/10 procedure codes. Odds ratios (ORs) with 95% confidence intervals (CIs) for return visits were calculated. Multivariate logistic regression analysis was used to measure association between opioid prescriptions and return visit rates as well as FDA warning and return visit rates adjusting for confounders.
Results:
There were 4778 patients who underwent T + A, median age, 5 years. Of these, 752 (15.7%) had return visits. Pain-related return visits were higher in patients who received opioid prescriptions (adjusted OR, 1.31; 95% CI, 1.09-1.57). After FDA warning, opioids were prescribed at a lower rate (47.9%) compared with previous (98.6%) (OR, 0.01; 95% CI, 0.008-0.02). Pain-related return visits were lower after FDA warning (OR, 0.73; 95% CI, 0.61-0.87). Steroid prescription rate increased after FDA warning (OR, 415; 95% CI, 197-874).
Conclusions:
Opioid prescriptions were associated with higher pain-related return visits after T + A, whereas issuance of FDA black box warning against codeine use was associated with lower pain-related return visits. Our data suggest that the black box warning potentially had unintended benefits in pain management and health care usage.
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