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

Opioid Induced Respiratory Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860885
• Other study ID #: CIN1-2012-1219
• Status: Completed
• Phase: N/A
• First received: May 15, 2013
• Last updated: May 21, 2013
• Start date: August 2012
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Opioid Induced Respiratory Depression
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Descriptive: Medical history and Risk Factors for critical respiratory events requiring Naloxone in children	Data leading to the event and post-event descriptives will be collected	about 6 hours around the event	Yes