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

NCT01860885 | Completed

• 1 other identifier: CIN1-2012-1219
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Induced Respiratory Depression

Keywords

naloxone; children; opioid; respiratory depression; safety

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients requiring naloxone for respiratory depression

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients who required rescue with naloxone between June 2006 and June 2012; identified based upon an automated trigger report generated from the hospital's risk management database for any dispensation of naloxone from the hospital pharmacy

You may qualify if:

• any gender, age or race
• administered naloxone for opioid induced respiratory depression

You may not qualify if:

• Any one who did not require naloxone for opioid induced respiratory depression

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2013
• First Posted: May 23, 2013
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 23, 2013

Record last verified: 2013-05

Locations

US (1)