- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860885
Critical Respiratory Events in Children Requiring Naloxone: Naloxone Use as Opioid Safety Measure
May 21, 2013 updated by: Children's Hospital Medical Center, Cincinnati
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
Conditions
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
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Ohio
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Cincinnati, Ohio, United States, 45229
- Cincinnati Children's Hospital Medical Center
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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 |
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Patients requiring naloxone for respiratory depression
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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
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Data leading to the event and post-event descriptives will be collected
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about 6 hours around the event
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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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIN1-2012-1219
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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