title: Opioid-related adverse drug events: do parents recognize the signals?
abstract: OBJECTIVE
  Evidence of unrelieved childhood pain, adverse drug events (ADE), and deaths suggest that parents may inadequately respond to pain and opioid-related ADE signals. This study examined parents' recognition and response to pain and ADE signals using both dynamic hypothetical scenarios and real at-home opioid decisions.
  
  
  METHODS
  A total of 514 parents whose children required prescription opioids after discharge were surveyed. Parents made analgesic decisions for 4 hypothetical scenarios wherein the child's pain level and ADE symptoms were altered. After discharge, parents recorded their child's real pain levels, ADEs, and their analgesic decisions. Mixed-effects logistic regression examined the influence of pain and ADE signals on parents' opioid decisions.
  
  
  RESULTS
  Pain intensity had a main effect on parents' hypothetical and real decisions to give opioids (P≤0.001). Nausea/vomiting influenced the decision to give the prescribed opioid dose (β=-1.48 [95% confidence interval (CI): -1.78, -1.19], P<0.001) as did oversedation (β=-1.02 [95% CI: -1.30, -0.75], P<0.001); however, parents were more likely to give the prescribed dose for oversedation than nausea/vomiting (odds ratio (OR) =1.53 [95% CI: 1.14, 2.05], P=0.005). Gastrointestinal effects were more likely to motivate a change in postdischarge opioid administration compared with other ADEs (OR=4.41 [95% CI: 1.91, 10.18], P<0.001), whereas sedation symptoms did not (OR=0.46 [95% CI: 0.21, 1.04], P=0.06).
  
  
  CONCLUSIONS
  Findings demonstrated that many parents failed to withhold a prescribed opioid dose for oversedation, suggesting a lack of awareness regarding this potentially serious ADE. Strategies to improve parents' recognition of oversedation and its potential consequences are warranted to improve opioid safety.
authors.affiliation: *Department of Anesthesiology-Pediatric Section †Department of Health Behavior and Health Education, School of Public Health ‡Department of Internal Medicine §School of Nursing, University of Michigan, Ann Arbor, MI.
authors.forename: Terri
authors.initials: T
authors.lastname: Voepel-Lewis
authors.forename: Brian
authors.initials: B
authors.lastname: Zikmund-Fisher
authors.forename: Ellen L
authors.initials: EL
authors.lastname: Smith
authors.forename: Sarah
authors.initials: S
authors.lastname: Zyzanski
authors.forename: Alan R
authors.initials: AR
authors.lastname: Tait
mesh_terms: D000293:Adolescent; D000701:Analgesics, Opioid / Q000009:adverse effects*; D016009:Chi-Square Distribution; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis* / Q000503:physiopathology*; D005260:Female; D006306:Health Surveys; D006801:Humans; D016015:Logistic Models; D008297:Male; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy* / Q000503:physiopathology; D010290:Parents / Q000523:psychology*
chemical_list: D000701:Analgesics, Opioid