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


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

    Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

    At, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.