Randomised trial of intranasal versus intramuscular naloxone in prehospital treatment for suspected opioid overdose

Abstract

Objective: To determine the effectiveness of intranasal (IN) naloxone compared with intramuscular (IM) naloxone for treatment of respiratory depression due to suspected opiate overdose in the prehospital setting. Design: Prospective, randomised, unblinded trial of either 2 mg naloxone injected intramuscularly or 2 mg naloxone delivered intranasally with a mucosal atomiser. Participants and setting: 155 patients (71 IM and 84 IN) requiring treatment for suspected opiate overdose and attended by paramedics of the Metropolitan Ambulance Service (MAS) and Rural Ambulance Victoria (RAV) in Victoria. Main outcome measures: Response time to regain a respiratory rate greater than 10 per minute. Secondary outcome measures were proportion of patients with respiratory rate greater than 10 per minute at 8 minutes and/or a GCS score over 11 at 8 minutes; proportion requiring rescue naloxone; rate of adverse events; proportion of the IN group for whom IN naloxone alone was sufficient treatment. Results: The IM group had more rapid response than the IN group, and were more likely to have more than 10 spontaneous respirations per minute within 8 minutes (82% v 63%; P = 0.0173). There was no statistically significant difference between the IM and IN groups for needing rescue naloxone (13% [IM group] v 26% [IN group]; P = 0.0558). There were no major adverse events. For patients treated with IN naloxone, this was sufficient to reverse opiate toxicity in 74%. Conclusion: IN naloxone is effective in treating opiate‐induced respiratory depression, but is not as effective as IM naloxone. IN delivery of naxolone could reduce the risk of needlestick injury to ambulance officers and, being relatively safe to make more widely available, could increase access to life‐saving treatment in the community.

Pharmacokinetic Properties and Human Use Characteristics of an FDA‐Approved Intranasal Naloxone Product for the Treatment of Opioid Overdose

“…Individuals administering the naloxone are instructed to give half a vial, or 1 mL, in each nostril (for a total dose of 2 mL); a second dose can be administered if the patient has not responded to the first dose. 9,10 Despite multiple reports describing the effectiveness of using these improvised intranasal devices in reversing opiate overdose, [9][10][11]13,14 a high error rate has been associated with both kit assembly and proper IN administration, even in individuals receiving training. 15 Moreover, it is not known if the pharmacokinetic (PK) properties of naloxone produced by these improvised IN devices are equivalent to the approved dose of parenterally administered naloxone.…”

Ambulance attendances resulting from self-harm after release from prison: a prospective data linkage study

“…Finally, a considerable amount of funding and research effort has been dedicated recently to preventing overdoses in formerly incarcerated adults (49)(50)(51)(52), including research with paramedics in Australia (53,54). However, despite the incidence of self-harm being higher than the incidence of nonfatal overdose in ex-prisoners (22,52,55), the same efforts have not been directed to this important issue.…”

Opioid Harm Reduction Strategies: Focus on Expanded Access to Intranasal Naloxone

“…Emergency medical services programs in Boston, Denver, and San Francisco use this drug administration technique as the standard of care. [19][20][21][22] An additional reason to advocate intranasal delivery of naloxone is that there are different tiers of responsibility and professional scopes of practice within the emergency medical services staff. For example, paramedics are authorized to start intravenous lines and administer injections whereas emergency medical technicians (EMTs) are not.…”

“…A similar randomized trial, also reported in 2005, comparing intranasal naloxone 2 mg with intramuscular naloxone 2 mg produced similar results. 21 Two other reports published in 2005 and 2009 compared intravenous naloxone with intranasal naloxone in the "prehospital" setting of the San Francisco emergency medical services area. 22,23 One hundred fifty-four patients were enrolled; 100 received intravenous and 54 received intranasal treatment.…”