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NCT01860885 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.

Completed
Registry status
95
Enrollment target

NCT01860885: Completed study, sponsored by Children's Hospital Medical Center, Cincinnati.

NCT01860885 is a clinical trial that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 95 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01860885 has completed, sponsored by Children's Hospital Medical Center, Cincinnati.

COMPLETED
Registry status
95 participants
Enrollment target

Study 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.

Primary Outcome

Data leading to the event and post-event descriptives will be collected

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2012-08
Est. Completion 2013-05

What the finished NCT01860885 record still lists

NCT01860885 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 95 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01860885 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01860885 about?

NCT01860885 is a clinical study titled "Critical Respiratory Events in Children Requiring Naloxone: Naloxone Use as Opioid Safety Measure". 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 medi...

What is the current status of trial NCT01860885?

This trial is currently completed. The enrollment target is 95 participants. The study started on 2012-08. Estimated completion is 2013-05.

Who is sponsoring clinical trial NCT01860885?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01860885, the US trial registry maintained by the National Library of Medicine. NCT01860885 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.