Testing The Intranasal Route For Administration of Haloperidol In Emergency Room: Generation of Efficacy Data To Support Clinical Practice

Abstract

TeSTiNg The iNTraNaSal rouTe For admiNiSTraTioN oF haloperidol iN emergeNCy room: geNeraTioN oF eFFiCaCy daTa To SupporT CliNiCal praCTiCe R. Vives Vilagut; R. Duno; N. Planet; G. Garcia; M. Payes; M. Marinosa; M.I. Iglesias-Lepine; and C. Pontes Hospital de Sabadell. Institut Universitari Parc TauliUniversitat Autonoma de Barcelona Background: Managing schizophrenic patients with agitation in the emergency room requires medications with a rapid onset of effect. Intravenous administration is impractical, and intramuscular dosing may be risky for both patients and health care professionals. The intranasal route may offer short Tmax with safer administration. Intranasal haloperidol has been reported to achieve similar plasma concentrations to intravenous dosing, but clinical data on the efficacy and safety of such approach is lacking. Psychiatrists contacted our Clinical Pharmacology Unit for methodological and logistic support to generate clinical information on the affectivity of haloperidol by the intranasal route. We present here the research protocol that was prepared. Methods: An exploratory randomized parallel observer-blinded clinical trial was designed to compare the administration of 5mg haloperidol by either intranasal or intramuscular route. The trial will include 40 agitated schizophrenic patients visited in the emergency room of Corporacio Parc Tauli who are candidates to receive haloperidol and provide previous informed consent (personally or through representative). Patients will be monitored up to 6 hours for agitation, cardiovascular parameters and adverse events. Treatments will be administered by unblinded nurses and agitation will be assessed in blind by an uninvolved psychiatrist. Main efficacy variable is the percentage of patients with score ≤ 9 in the 5 item PANSS-EC scale 20 minutes after dosing. Sample size is based on subject’s availability considering the exploratory nature of the trial. The study will be performed according to the Good Clinical Practice. Results: The clinical trial obtained Ethic’s and regulatory approvals during 2014. The first patient was recruited on December 2014. Recruitment is ongoing and expected to last 12 months. Conclusions: An exploratory trial has been prepared to help physicians to generate initial clinical information on the effectiveness of a simple intervention aimed to improve patient management by healthcare professionals in the emergency room.