The IN-MIDAZ study – Intranasal midazolam in aborting seizures – An epilepsy monitoring unit based randomized controlled trial for efficacy

• Published in: Epilepsy research Vol. 188; p. 107037
• Main Authors: Shaikh, Raja Gulfam, Ramanujan, Bhargavi, Singh, Rajesh Kumar, Vibha, Deepti, Mehta, Santosh, Appukuttan, Renjith, Tripathi, Manjari
• Format: Journal Article
• Language: English
• Published: Netherlands Elsevier B.V 01.12.2022
• Subjects: Administration, Intranasal; Adult; Anticonvulsants - adverse effects; Antiepileptic drugs; Child; Drug Resistant Epilepsy - drug therapy; EMU; Epilepsy; Humans; Intranasal; Midazolam; Midazolam - adverse effects; Midazolam - therapeutic use; Seizures - chemically induced; Seizures - drug therapy; Status Epilepticus - drug therapy; VEEG; Intranasal; IM; IN; Epilepsy; DRE; VEEG; Midazolam; EMU; Antiepileptic drugs; AEDs; PWE
• ISSN: 0920-1211; 1872-6844; 1872-6844
• DOI: 10.1016/j.eplepsyres.2022.107037

To compare efficacy and safety of Intranasal and Intramuscular routes of midazolam administration in terminating seizures. This was an open label Randomized controlled trial (RCT). People with drug resistant epilepsy (DRE) undergoing Video Electroencephalogram (VEEG) monitoring, were randomized in a 1:1 ratio to receive either Intranasal (IN) or Intramuscular (IM) midazolam, for prolonged seizures: longer than 5 min for focal, and longer than 2 min for focal to bilateral tonic-clonic. Outcome assessor was blinded to the allocation arm. Primary outcome was time to electrographic seizure termination after administration of midazolam. All adverse events in both the groups were noted. A total of 1108 seizures were recorded in 130 subjects, of which 110 (65 seizures in 23 subjects in IN group; 45 seizures in 18 subjects in IM group) seizures required midazolam administration and were included in final analysis. Mean time to electrographic seizure termination after midazolam administration was 45.1 ± 23.8 s in the IM group and 90.4 ± 59.0 s in the IN group (p = 0.0014); mean time to clinical seizure termination was 53.9 ± 25.8 s in IM group and 104.3 ± 66.4 s in the IN group (p = 0.002). Local side effects were more in IN group; hypotension as serious adverse event was noted in the IM group. Though mean time to electrographic and clinical seizure termination was significantly lesser in Intramuscular group for both adults and pediatric population, it was still under 2 min in the Intranasal midazolam group.IN midazolam is a useful option for terminating seizures. •To compare efficacy and safety of IN and IM routes of midazolam administration in terminating seizures.•PWE were randomized equally in IN or IM group for seizures longer than 5 min for focal and 2 min for focal to bilateral.•Primary outcome was time to electrographic seizure termination after administration of midazolam.•130 subjects, of which 110 seizures (65 in 23 subjects in IN group; 45 in 18 subjects in IM group) required midazolam.•Time to terminate seizure was significantly less in IM group for adults and chlidren, it was still under 2 min in IN group.