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

Completed

• Conditions: Opioid Induced Respiratory Depression

• Registration Number: NCT01860885
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Study First Submitted: 2013-05-15
• Study First Submitted QC: 2013-05-21
• Last Update Submitted: 2013-05-21
• Study First Posted: 2013-05-23
• Last Update Posted: 2013-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States