Buccal, intranasal or intravenous lorazepam for the treatment of acute convulsions in children in Malawi: An open randomized trial

Lissauer, Samantha, Kenny, Julia, Jefferis, Oliver, Wingfield, Tom ORCID: 0000-0001-8433-6887, Miller, Anne, Chagaluka, George, Kalilani-Phiri, Linda and Molyneux, Elizabeth (2015) Buccal, intranasal or intravenous lorazepam for the treatment of acute convulsions in children in Malawi: An open randomized trial. AFRICAN JOURNAL OF EMERGENCY MEDICINE, 5 (3). pp. 120-126.

Text Lorazepam Malawi African Journal Emerg Med.pdf - Published version Download (1MB)

Abstract

Introduction Acute convulsions in children are a common emergency worldwide. Benzodiazepines are the recommended first line treatment. Intravenous lorazepam is inexpensive, long acting and the first line drug in resource-rich settings. However, comparable efficacy by other routes of administration is unknown. We wished to compare the efficacy of lorazepam by the buccal, intranasal or intravenous route in the treatment of acute seizures in Malawian children. Methods A prospective, open-label, randomised, non-inferiority trial was performed in children aged 2 months to 14 years presenting to the Queen Elizabeth Central Hospital in Blantyre, Malawi with acute seizures lasting longer than 5 min. Children were randomly assigned to receive lorazepam, 0.1 mg/kg, by the buccal, intranasal or intravenous route. The primary endpoint was seizure cessation within 10 min of drug administration. Results There were 761 seizures analysed, with 252 patients in the buccal, 245 in the intranasal and 264 in the intravenous groups. Intravenous lorazepam stopped seizures within 10 min in 83%, intranasal lorazepam in 57% (RR 2.46, CI 1.82-3.34), and the buccal route in 46% (RR 3.14, CI 2.35-4.20; p = 0.001) of children. There were no significant cardio-respiratory events and no difference in mortality or neurological deficits. The study was halted after an interim analysis showed that the primary endpoint had exceeded the protocol-stopping rule. Conclusions Intravenous lorazepam effectively treats most childhood seizures in this setting. Intranasal and buccal routes are less effective but may be useful in pre-hospital care or when intravenous access cannot be obtained. Further studies comparing intranasal lorazepam to other benzodiazepines, or alternative doses by a non-intravenous route are warranted.

Item Type:	Article
Uncontrolled Keywords:	Clinical Trials and Supportive Activities, Neurodegenerative, Epilepsy, Brain Disorders, Neurosciences, Clinical Research, Pediatric
Depositing User:	Symplectic Admin
Date Deposited:	19 Oct 2016 14:31
Last Modified:	15 Mar 2024 16:44
DOI:	10.1016/j.afjem.2015.03.001
Related URLs:	Author Publisher
URI:	https://livrepository.liverpool.ac.uk/id/eprint/3003883