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

NCT ID: NCT01860885

Last Updated: 2013-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-05-31

Brief Summary

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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

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Conditions

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Opioid Induced Respiratory Depression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients requiring naloxone for respiratory depression

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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CIN1-2012-1219

Identifier Type: -

Identifier Source: org_study_id

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