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

Abstract

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.

Intranasal Opioid Administration in Rhesus Monkeys: PET Imaging and Antinociception

“…For example, Barton et al (2005) compared naloxone IV (1-2 mg) or IN (2 mg) for opioid overdose in humans, and found that both routes were equally effective in reversing overdose within 3 minutes. Other studies investigating IN versus IM or IV NLX for opioid overdose reached similar conclusions (e.g., Kerr et al, 2009;Sabzghabaee et al, 2014). Although the experimental design in the current study did not allow us to assess the onset of action, which was a noted limitation, the finding that NLX given IN and IV was equipotent in reversing antinociception is consistent with these single-dose studies in humans.…”

Clinical provision of improvised nasal naloxone without experimental testing and without regulatory approval: imaginative shortcut or dangerous bypass of essential safety procedures?

“…administration of naloxone reversing opioid overdose: at least 327 overdose reversals using nasal naloxone kits were reported in the Massachusetts ‐based take‐home naloxone scheme . In ambulance and hospital‐based trials, the time from dose administration to clinical response often took longer for nasal administration compared to injectable routes . However, for the comparison of i.n.…”

“…naloxone administration in healthy volunteers or patients with suspected opioid overdose. Eighteen records matched our search criteria (see Table and Fig. ).…”

Prescription Opioid Misuse, Abuse, and Treatment in the United States: An Update

“…When administered intramuscularly or intravenously, naloxone has a rapid effect on respiratory depression, within 1 to 2minutes of administration. Although initial investigations of intranasal naloxone did not support its effectiveness, a recent randomized clinical trial of an intranasal reformulation found that it was as effective as intravenous naloxone in reversing opioid overdose-induced respiratory and CNS depression (11). Intranasal naloxone has the advantage of reducing the risks of needle-stick injury and transmission of blood-borne illnesses, as well as the potential for peer administration of naloxone (12).…”