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

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

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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients requiring naloxone for respiratory depression

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
about 6 hours around the event

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

May 1, 2013

Study Registration Dates

First Submitted

May 15, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (ESTIMATE)

May 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2013

Last Update Submitted That Met QC Criteria

May 21, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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