Table 2.
Summary of the demographic characteristics of the participants enrolled in the four included trials
| Study ID | Study arm | N analysed | Age, years, mean (SD) | Gender (M/F), n (%) | Ethnicity, % | Final diagnosis, n (%) | Time from onset of convulsive SE to study drug admin; minutes, mean (SD) or median [range] |
|---|---|---|---|---|---|---|---|
| [15] | IV lorazepam | 66 | 49.9 (20.1) |
M 46 (70%) F 20 (30%) |
Black: 18.2% White: 48.5% Othera: 33.3% |
NR | 34.0 (17.8) |
| IV diazepam | 68 | 50.4 (19.1) |
M 41 (60%) F 27 (40%) |
Black: 16.2% White: 54.4% Othera: 29.4% |
NR | 31.3 (14.5) | |
| IV placebo | 71 | 52.0 (18.2) |
M 42 (59%) F 29 (41%) |
Black: 29.6% White: 46.5% Othera: 23.9% |
NR | 46.7 (38.8) | |
| [21] | IV levetiracetam + clonazepam | 68 | 55 (18) |
M 49 (72%) F 19 (28%) |
NR |
SE: 66 (97.1%) Non-epileptic: 2 (2.9%) |
58 [15–135] |
| IV placebo + clonazepam | 68 | 53 (18) |
M 45 (66%) F 23 (34%) |
NR |
SE: 64 (94.1%) Non-epileptic: 4 (5.9%) |
60 [20–258] | |
| [23] | IV phenobarbital + phenytoin | 18 | 55.9 (19.4) |
M 13 (72%) F 5 (28%) |
NR |
GCSE*: 18 (100%) Other**: 0 (0%) |
NR |
| IV diazepam + phenytoin | 18 | 43.8 (16.5) |
M 9 (50%) F 9 (50%) |
NR |
GCSE*: 17 (94%) Other**: 1 (6%) |
NR | |
| [22] | IM midazolam | 391 | 48 (17) |
M 217 (56%) F 174 (44%) |
Black: 54.0% White: 35.3% Othera: 10.7% |
SE: 352 (90%) Non-epileptic: 28 (7%) Undetermined: 11 (3%) |
NR |
| IV lorazepam | 391 | 49 (18) |
M 203 (52%) F 188 (48%) |
Black: 52.2% White 39.9% Othera: 7.9% |
SE: 348 (89%) Non-epileptic: 29 (7%) Undetermined: 14 (4%) |
NR |
GCSE generalised convulsive status epileptics; IM intramuscular; IV intravenous; NR not reported; SD standard deviation; SE status epilepticus
aOther, mixed or unknown
*GCSE for entrance into study defined as a history of 30 min of continuous GCSE, and witnessed generalised seizures in the emergency room; or a history of 30 min of recurrent GCSE but failure to attain baseline mental status between seizures, and witnessed generalised seizures in the emergency room
**Includes a history of three or more GCSE in 1 h in patients with obtundation prior to the onset of status epilepticus and witnessed generalised convulsive seizures in the emergency room; or uncertain history of seizures but generalised convulsive seizures continuously for more than 5 min as witnessed in the emergency room