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Clinical Trials/NCT01860885
NCT01860885
Completed
Not Applicable

Study of Hospital-wide Critical Respiratory Events Requiring Naloxone in a Pediatric Institution

Children's Hospital Medical Center, Cincinnati1 site in 1 country95 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid Induced Respiratory Depression
Sponsor
Children's Hospital Medical Center, Cincinnati
Enrollment
95
Locations
1
Primary Endpoint
Descriptive: Medical history and Risk Factors for critical respiratory events requiring Naloxone in children
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
May 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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