Comparison of Two Naloxone Regimens in Opioid-dependent Methadone-overdosed Patients: A Clinical Trial Study

Abstract

Background: Methadone toxicity is one of the major causes of death in opioid-dependent individuals. Objective: We aimed to compare two different protocols of naloxone administration in terms of reversal of overdose signs and symptoms and frequency of complications in opioid-dependent methadone-intoxicated patients. Method: One-hundred opioid-dependent patients with signs/symptoms of methadone overdose were included. The patients were consecutively assigned into Tintinalli (group 1) or Goldfrank regimen protocol (group 2) of naloxone administration. Group 1 received naloxone with the dose 0.1 mg given every two to three minutes while group 2 received naloxone with the initial dose of 0.04 mg increasing to 0.4, 2, and 10 mg every two to three minutes to reverse respiratory depression. They were then compared regarding reversal of toxicity and risk of development of complications. Results: The time to reversal of the overdose signs/symptoms was significantly less in Goldfrank regimen protocol (P<0.001). Frequency of withdrawal syndrome and recurrence of respiratory depression were not significantly different between the two groups. Aspiration pneumonia and intubation were more frequent in group 2, as well. Conclusion: It seems that gradual titration of naloxone by Tintinalli protocol can reduce major complications compared to the Goldfrank regimen. However, this protocol was not perfect in opioid-dependent methadone-overdosed patients, either, since it could induce complications, as well. We may need new protocols in overdosed opioid-dependent patients.