European journal of clinical pharmacology
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Eur. J. Clin. Pharmacol. · Jul 2018
Randomized Controlled TrialPharmacokinetics and -dynamics of intramuscular and intranasal naloxone: an explorative study in healthy volunteers.
This study aimed to develop a model for pharmacodynamic and pharmacokinetic studies of naloxone antagonism under steady-state opioid agonism and to compare a high-concentration/low-volume intranasal naloxone formulation 8 mg/ml to intramuscular 0.8 mg. ⋯ A target-controlled infusion of remifentanil provides good conditions for studying the pharmacodynamics of naloxone, and pupillometry was a better modality than heat pain threshold. Intranasal naloxone 0.8 mg is inferior for a similar dose intramuscular. Our design may help to bridge the gap between studies in healthy volunteers and the patient population in need of naloxone for opioid overdose.