Geeta Gathwala1, Mayank Goel, Jagjit Singh, Kundan Mittal. 1. Departments of Pediatrics, Pt. B.D.Sharma PGIMS, University of Health Sciences Rohtak, 6J/8, Medical Enclave, Rohtak, 124001 Haryana, India. g_gathwala@hotmail.com
Abstract
OBJECTIVE: To evaluate the safety and efficacy of three benzodiazepine drugs: Lorazepam, Midazolam and Diazepam, when given parenterally in the control of acute seizure. METHODS:One hundred and twenty children of either sex in the age group 6 month to 14 years brought convulsing to the pediatric emergency services, were enrolled in the study. These were randomised to three equal groups of 40 patients each; Group A-received diazepam, Group B-received midazolam, Group C-received lorazepam. End of seizure episode (clinically) was defined as cessation of visible epileptic phenomenon or return of purposeful response to external stimuli within 15 min of drug administration. A stopwatch was used to measure various time intervals accurately. The patient's vitals were monitored and recorded in a predesigned performa. The primary outcome was the time to seizure cessation and secondary outcome was the side effects of the drugs. Data obtained was analysed statistically using student's t-test and chi-square test. RESULTS:Mean duration to clinical seizure cessation was comparable among the three groups. For diazepam group it was 84.94 ± 38.56 s, for midazolam group it was 92.69 ± 25.97 s, for lorazepam group it was 91.12 ± 23.58 s. Number of patients with any abnormality in seizure cessation were significantly higher in diazepam group [11/40 (27.5%)] when compared to the midazolam [4/40 (10%)] and lorazepam group [2/40 (5%)]. Number of patients requiring 2nd dose to control seizures was significantly higher [4/40 (10%)] in diazepam group when compared to lorazepam group [0/40 (0%)] but diazepam and midazolam and midazolam and lorazepam were comparable in this aspect.All the three drugs were comparable in terms of side effects except excessive somnolence which was significantly higher in diazepam group. CONCLUSIONS: All the three groups were comparable in terms of time to clinical seizure cessation, seizure recurrence and uncontrolled seizures after drug administration. However, number of patients requiring second dose to control seizures were significantly higher in diazepam group when compared to lorazepam group. Excessive somnolence and sedation occurred more frequently with diazepam.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of three benzodiazepine drugs: Lorazepam, Midazolam and Diazepam, when given parenterally in the control of acute seizure. METHODS: One hundred and twenty children of either sex in the age group 6 month to 14 years brought convulsing to the pediatric emergency services, were enrolled in the study. These were randomised to three equal groups of 40 patients each; Group A-received diazepam, Group B-received midazolam, Group C-received lorazepam. End of seizure episode (clinically) was defined as cessation of visible epileptic phenomenon or return of purposeful response to external stimuli within 15 min of drug administration. A stopwatch was used to measure various time intervals accurately. The patient's vitals were monitored and recorded in a predesigned performa. The primary outcome was the time to seizure cessation and secondary outcome was the side effects of the drugs. Data obtained was analysed statistically using student's t-test and chi-square test. RESULTS: Mean duration to clinical seizure cessation was comparable among the three groups. For diazepam group it was 84.94 ± 38.56 s, for midazolam group it was 92.69 ± 25.97 s, for lorazepam group it was 91.12 ± 23.58 s. Number of patients with any abnormality in seizure cessation were significantly higher in diazepam group [11/40 (27.5%)] when compared to the midazolam [4/40 (10%)] and lorazepam group [2/40 (5%)]. Number of patients requiring 2nd dose to control seizures was significantly higher [4/40 (10%)] in diazepam group when compared to lorazepam group [0/40 (0%)] but diazepam and midazolam and midazolam and lorazepam were comparable in this aspect.All the three drugs were comparable in terms of side effects except excessive somnolence which was significantly higher in diazepam group. CONCLUSIONS: All the three groups were comparable in terms of time to clinical seizure cessation, seizure recurrence and uncontrolled seizures after drug administration. However, number of patients requiring second dose to control seizures were significantly higher in diazepam group when compared to lorazepam group. Excessive somnolence and sedation occurred more frequently with diazepam.
Authors: Lawrence C Ku; Christoph P Hornik; Ryan J Beechinor; James M Chamberlain; Jeffrey T Guptill; Barrie Harper; Edmund V Capparelli; Karen Martz; Ravinder Anand; Michael Cohen-Wolkowiez; Daniel Gonzalez Journal: CPT Pharmacometrics Syst Pharmacol Date: 2018-09-28
Authors: Adam Strzelczyk; Laurent M Willems; Ricardo Kienitz; Lara Kay; Isabelle Beuchat; Sarah Gelhard; Sophie von Brauchitsch; Catrin Mann; Alexandra Lucaciu; Jan-Hendrik Schäfer; Kai Siebenbrodt; Johann-Philipp Zöllner; Susanne Schubert-Bast; Felix Rosenow Journal: CNS Drugs Date: 2022-08-16 Impact factor: 6.497