Critical Respiratory Events in Children Requiring Naloxone: Naloxone Use as Opioid Safety Measure

Overview

Opioids are the mainstay of analgesia in hospitalized children but opioid therapy is associated with life-threatening respiratory depression requiring antagonism with naloxone. Hence, it is hypothesized that naloxone requirement can be used as a quality measure of opioid safety. A retrospective medical chart review of 95 patients, who received naloxone for life threatening events, from June 2006-2012, is planned, to identify significant factors associated with risk for opioid induced respiratory depression and formulation of preventive strategies.

Full Title of Study: “Study of Hospital-wide Critical Respiratory Events Requiring Naloxone in a Pediatric Institution”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: May 2013

Arms, Groups and Cohorts

  • Patients requiring naloxone for respiratory depression

Clinical Trial Outcome Measures

Primary Measures

  • Descriptive: Medical history and Risk Factors for critical respiratory events requiring Naloxone in children
    • Time Frame: about 6 hours around the event
    • Data leading to the event and post-event descriptives will be collected

Participating in This Clinical Trial

Inclusion Criteria

  • any gender, age or race – administered naloxone for opioid induced respiratory depression Exclusion Criteria:
  • Any one who did not require naloxone for opioid induced respiratory depression
  • Gender Eligibility: All

    Minimum Age: N/A

    Maximum Age: N/A

    Are Healthy Volunteers Accepted: No

    Investigator Details

    • Lead Sponsor
      • Children’s Hospital Medical Center, Cincinnati
    • Provider of Information About this Clinical Study
      • Sponsor

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