Comparison of intranasal and intramuscular naloxone in opioid overdoses managed by ambulance staff: A double-dummy, randomized, controlled trial
Addiction Feb 11, 2022
Researchers conducted a randomized, controlled, double-dummy, blinded, non-inferiority trial, with the aim of measuring and evaluating clinical response to nasal naloxone in opioid overdoses in the prehospital environment.
Men and women aged above 18 years with miosis, rate of respiration ≤ 8/min, and Glasgow Coma Score < 12/15 were randomized to a commercially available 1.4 mg/0.1 mL intranasal naloxone or 0.8 mg/2 mL naloxone administered intramuscularly.
In the per-protocol population, analysis of 201 participants was done.
In 196 cases, heroin was suspected.
Relative to 0.8 mg intramuscular naloxone, intranasal naloxone (1.4 mg/0.1 mL) was identified as less efficient for return to spontaneous breathing within 10 minutes in overdose patients in the prehospital environment when compared head-to-head.
Eighty percent of the participants had restored breathing after receiving one dose of intranasal naloxone at 1.4 mg/0.1 mL with few mild adverse reactions.
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