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 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Induced Respiratory Depression Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

1 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: May 23, 2013
Registry last updated: May 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting