Effectiveness and safety of large bolus intramuscular naloxone for opioid poisoning in the Emergency Department

Phase 4

Completed

• Conditions: Opioid poisoning; Emergency medicine - Other emergency care; Injuries and Accidents - Poisoning

• Registration Number: ACTRN12621000062820
• Lead Sponsor: Princess Alexandra Hospital Clinical Toxicology Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-25
• Study Completion: 2023-10-18
• Last Update Posted: 15 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Adult patients > 17 years old presenting to the Princess Alexandra Hospital Emergency Department that require naloxone to reverse respiratory depression (defined as a respiratory rate < 10 or oxygen saturations < 93%) due to suspected opioid poisoning

Exclusion Criteria

•Patients in which intravenous access is unable to be obtained
•Patients who have iatrogenic poisoning following opioid administration for acute pain
•Patients who are intubated and ventilated for management of concurrent conditions such as aspiration pneumonitis or to facilitate management of co-ingestions agents.
•Patients in police or corrections custody

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with recurrence of opioid toxicity (defined as respiratory rate <10 and/or oxygen saturations <93%) documented in patient medical records.[ 4-hour period following the intramuscular administration of either 1.6mg naloxone or saline]

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with reversal of opioid toxicity (defined as respiratory rate greater than or equal to 10 and oxygen saturations greater than or equal to 93%) documented in patient medical records.[ 10 minutes following naloxone administration];Total number of IV naloxone administrations documented in patient medical records.[ During presentation];Rate of naloxone infusion administration documented in patient medical records[ During patient presentation];Rate of any clinically significant features of withdrawal (tachycardia, hypertension, vomiting, acute behavioural disturbance, myocardial infarction, arrhythmia, pulmonary oedema, seizure, Subjective Opioid Withdrawal score) documented in patient medical records.[ 4-hour period following the intramuscular administration of either 1.6mg naloxone or saline]