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Clinical Summary

Intranasal naloxone not as effective as intramuscular

Takeaway

  • Opioid overdose patients who received intranasal naloxone hydrochloride were significantly more likely to require a rescue dose than patients who received the same naloxone dosage intramuscularly.

Why this matters

  • This was the first blinded, randomized trial to study the efficacy of the 2 methods for administering naloxone.

Study design

  • Double-blind, double-dummy randomized clinical trial on 197 individuals (aged, ≥18 years) with a history of injecting drug use.
  • Treatment: 800 μg naloxone hydrochloride/mL intranasal (n=104) or intramuscular (n=93) modes.
  • All participants received an intramuscular injection and an intranasal spray (active/placebo).
  • Funding: New South Wales Department of Health Drug and Alcohol Services.

Key results

  • Requirement for rescue dose of naloxone was less likely in intramuscular vs intranasal naloxone group (8.6% vs 23.1%; OR, 0.35; P=.002).
  • The median time to adequate Glasgow Coma Scale scores ≥13 in intramuscular vs intranasal groups:
    • 8.0 vs 15.0 minutes (HR, 1.65; P=.002).
  • The median time to respiratory rate of at least 10 breaths/minute in intramuscular vs intranasal groups:
    • 8.0 vs 17.0 minutes (HR, 1.81; P=.001).
  • No major adverse events were reported for either group.

Limitations

  • The application of the findings to other potent opioids is unknown.

Coauthored with Chitra Ravi, MPharm


References


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