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

Kelly, Anne‐Maree; Kerr, Debra; Dietze, Paul

doi:10.5694/j.1326-5377.2005.tb06766.x

Cited by 42 publications

(68 citation statements)

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“…Another study of 155 participants administered IM (n=71) or IN (n=84) naloxone involved no major adverse events. 59 Other studies have shown that while there is a longer mean response time and an additional dose of naloxone required when using IN naloxone, there were no additional adverse outcomes associated with its use. 59, 64, 65 …”

Section: Resultsmentioning

confidence: 96%

A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming into Clinical Practice

et al. 2015

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Background As physicians have increased opioid prescribing, overdose deaths from pharmaceutical opioids have substantially increased in the United States. Naloxone hydrochloride (naloxone), an opioid antagonist, is the standard of care for treatment of opioid induced respiratory depression. Since 1996, community-based programs have offered overdose prevention education and distributed naloxone for bystander administration to people who use opioids, particularly heroin. There is growing interest in translating overdose education and naloxone distribution (OEND) into conventional medical settings for patients who are prescribed pharmaceutical opioids. For this review, we summarized and classified existing publications on overdose education and naloxone distribution to identify evidence of effectiveness and opportunities for translation into conventional medical settings. Methods For this review, we searched English language PubMed for articles on naloxone based on primary data collection from humans, including feasibility studies, program evaluations, surveys, qualitative studies and studies comparing the effectiveness of different routes of naloxone administration. We also included cost-effectiveness studies. Results We identified 41 articles that represented 5 categories: evaluations of OEND programs, effects of OEND programs on experiences and attitudes of participants, willingness of medical providers to prescribe naloxone, comparisons of different routes of naloxone administration, and the cost-effectiveness of naloxone. Conclusions Existing research suggests that people who are at risk for overdose and other bystanders are willing and able to be trained to prevent overdoses and administer naloxone. Counseling patients about the risks of opioid overdose and prescribing naloxone is an emerging clinical practice which may reduce fatalities from overdose while enhancing the safe prescribing of opioids.

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Section: Resultsmentioning

confidence: 96%

A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming into Clinical Practice

et al. 2015

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“…First, the assignment of Critical Task Errors for NXN required the determination of a “clinically meaningful dose.” Because nasally administered naloxone is not an FDA approved route of administration, the selection of the dose was based on published literature in which a full dose of 1 mL is administered into each nostril [8, 15–18]. Several studies describe the need for additional doses of naloxone, therefore, the study team viewed the full dose of NXN as the minimally effective amount [24, 25].…”

Section: Discussionmentioning

confidence: 99%

Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery

Edwards

Davis³

et al. 2015

Pain Ther

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IntroductionThe standard of care for reversal of opioid-induced respiratory depression associated with opioid overdose is injectable naloxone. This study compared the usability of two naloxone delivery devices, a naloxone auto-injector (NAI) and a naloxone intranasal delivery system (NXN), in the administration of naloxone during a simulated opioid overdose emergency. NAI (EVZIO®; kaleo, Inc., Richmond, VA, USA) is a Food and Drug Administration approved single-use pre-filled auto-injector containing 0.4 mg of naloxone.MethodsStudy participants were randomly assigned to administer naloxone using NAI and NXN, sequentially. The primary endpoint was successful administration of a simulated dose of naloxone into a mannequin during a simulated opioid emergency, both before and after receiving training. Secondary endpoints included using the NAI or NXN in accordance with the instructions-for-use and the comparative measurement of successful completion time of administration for both NAI and NXN.ResultsA total of 42 healthy participants aged 18–65 years were enrolled in the study. The proportion of participants able to successfully administer a simulated dose of naloxone was significantly greater for NAI compared to NXN both before (90.5% vs. 0.0%, respectively, P < 0.0001) and after (100% vs. 57.1%, respectively, P < 0.0001) participant training. The proportion of participants able to administer a simulated dose of naloxone in accordance with the instructions-for-use was also significantly greater for NAI compared to NXN before (85.7% vs. 0.0%, respectively, P < 0.0001) and after (100% vs. 0.0%, respectively, P < 0.0001) participant training. The average time to task completion for administration attempt before training was 0.9 ± 0.25 min for NAI versus 6.0 ± 4.76 min for NXN and after training was 0.5 ± 0.15 min for NAI versus 2.0 ± 2.15 min for NXN.ConclusionLaypersons experienced substantially greater success administering a simulated dose of naloxone, both before and after training, using NAI versus NXN during a simulated opioid overdose emergency. No participants correctly used NXN without training.Electronic supplementary materialThe online version of this article (doi:10.1007/s40122-015-0035-9) contains supplementary material, which is available to authorized users.

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“…Unfortunately such studies have suffered from several limitations such as lack of randomization or blinding and reliance on the subjective reporting of paramedics who were required to record times, administer medications and assess appropriate patient responses [4, 14–18]. …”

Section: Introductionmentioning

confidence: 99%

Naloxone therapy in opioid overdose patients: intranasal or intravenous? A randomized clinical trial

Sabzghabaee

Eizadi-Mood

Yaraghi

et al. 2014

aoms

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IntroductionThis study was designed to compare the effects of intranasal (IN) and intravenous (IV) administration of naloxone in patients who had overdosed on opioids.Material and methodsThis randomized clinical trial study was conducted in the Department of Poisoning Emergencies at Noor and Ali Asghar (PBUH) University Hospital. One hundred opioid overdose patients were assigned by random allocation software into two study groups (n = 50). Both groups received 0.4 mg naloxone: one group IN and the other IV. Outcomes included change in the level of consciousness (measured using a descriptive scale and the Glasgow Coma Scale (GCS)), time to response, vital signs (blood pressure, heart rate and respiratory rate), arterial blood O2 saturation before and after naloxone administration, side-effects (agitation) and length of hospital stay.ResultsPatients who had been administered IN naloxone demonstrated significantly higher levels of consciousness than those in the IV group using both descriptive and GCS scales (p < 0.001). There was a significant difference in the heart rate between IN and IV groups (p = 0.003). However, blood pressure, respiratory rate and arterial O2 saturation were not significantly different between the two groups after naloxone administration (p = 0.18, p = 0.17, p = 0.32). There was also no significant difference in the length of hospital stay between the two groups (p = 0.14).ConclusionsIntranasal naloxone is as effective as IV naloxone in reversing both respiratory depression and depressive effects on the central nervous system caused by opioid overdose.

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

Cited by 42 publications

References 1 publication

A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming into Clinical Practice

A Review of Opioid Overdose Prevention and Naloxone Prescribing: Implications for Translating Community Programming into Clinical Practice

Comparative Usability Study of a Novel Auto-Injector and an Intranasal System for Naloxone Delivery

Naloxone therapy in opioid overdose patients: intranasal or intravenous? A randomized clinical trial

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