Clinical Outcomes From Nalmefene

Purdue Pharma LP

Overview

The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Opioid Overdose

Interventions

Nalmefene Hydrochloride InjectionDRUG

for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration

Naloxone Hydrochloride InjectionDRUG

for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Presumed or known opioid overdose in community settings. 2. Experiencing clinically significant respiratory depression based on appropriate medical judgement. 3. Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.) 4. Pre-hospital naloxone administration is allowed. Exclusion Criteria: 1. Patient age known or estimated to be less than 18 years. 2. Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome. 3. Cardiac arrest, secondary to opioid intoxication. 4. Arrested, jailed, or imprisoned patients. 5. Inappropriate for the study per judgement of research team.

Outcomes

Primary Outcomes

Reversal of Respiratory Depression

Normalization of the end tidal carbon dioxide value (if measured) to between 35 and 45 mmHg and/or ≥5 breaths per minute increase in respiratory rate from baseline (pre-dose) measurement, with rate of at least 12 breaths per minute.

Time frame: Up to 3 hours

Secondary Outcomes

Time to Reversal from administration of opioid antagonist

Time frame: Up to 3 hours

Recurrence of Respiratory Depression

Increased end tidal carbon dioxide value (if measured) above 45 mmHg when previously within the normal range and/or ≥5 breaths per minute decrease in respiratory rate from maximum post-reversal measurement, with a rate of at most 12 breaths per minute.

Time frame: Up to 3 hours

ED Disposition

One of the following will apply: * ED Discharge * Hospital Admission * ICU Admission * Left against medical advice * Transfer to another facility * Death.

Time frame: Up to 3 hours

Drug Dosing

1. Dose administered for each opioid antagonist given to patients during their ED encounter - * Individual dose amount and frequency * Cumulative dose 2. Any pre-hospital naloxone given prior to ED arrival - * Dose amount, route

Time frame: Up to 3 hours

Richmond-Agitation Sedation Scale (RASS) Score

This is a single-item instrument used to quickly assess the degree of patient alertness and agitation in emergency and critical care settings. It is an observational assessment conducted by healthcare providers, and it can be completed in seconds. The scale uses integers from -5 to +4, each with its own clear anchor. A score of 0 means that the patient is alert and calm. Negative integers indicate diminished responsiveness and consciousness, with -1 indicating that a patient will open their eyes or make eye contact for 10 or more seconds when awakened by voice, and -5 meaning that the patient is unarousable by voice or physical stimulation. Positive integers indicate an increased level of arousal or agitation. The positive end of the scale spans from +1 (anxious, apprehensive, but not aggressive) to +4 (combative, violent, danger to staff).

Data from ClinicalTrials.gov

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