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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01860885

Enrollment

Registered

2013-05-23

Start date

2012-08-31

Completion date

2013-05-31

Last updated

2013-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Induced Respiratory Depression

Keywords

naloxone, children, opioid, respiratory depression, safety

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Descriptive: Medical history and Risk Factors for critical respiratory events requiring Naloxone in children	about 6 hours around the event	Data leading to the event and post-event descriptives will be collected

Countries

United States

Outcome results