548 COMPARISON OF INTRANASAL MIDAZOLAM WITH RECTAL DIAZEPAM FOR TREATING SEIZURES IN CHILDREN: A PROSPECTIVE, RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED TRIAL.
Bibliographic record
Abstract
Purpose To determine the efficacy of intranasal (IN) midazolam in the management of pediatric patients between 6 months and 16 years of age presenting with an active seizure. Our hypothesis is that IN midazolam is more effective in stopping seizure activity than rectal (PR) diazepam and can do so in a shorter period of time from the time of presentation to hospital. Methods Inclusion criteria: (1) age between 6 months and 16 years old and (2) active seizure activity and duration of greater than 10 minutes. Exclusion criteria include (1) age less than 6 months old; (2) previous administration of any anti-epileptic medication for the presenting seizure episode; (3) spontaneous cessation of seizure; and (4) critical level of illness or injury, such that the following the study protocol would distract health professionals from providing other life-sustaining care. All children meeting the inclusion criteria will be treated in the same way. Each child will be assigned a package containing either an intravenous (IV) preparation of midazolam (which will be used IN) and a diazepam placebo, or midazolam placebo and PR preparation of diazepam. Both drug and placebo will be administered as contemporaneously as possible. After administration, patients will be monitored at regular intervals for 1 hour. Vital signs, time of seizure cessation, and any adverse events will be recorded. Treatment would be considered successful if seizures cease within 5 minutes of administration; successful but delayed if within 5 to 10 minutes; and failure if seizures persist beyond 10 minutes or recur. Results This study is currently in the process of enrolling patients. Implications for Practice Intranasal midazolam is a proven safe and effective means of managing acute seizures in children and may be a superior alternative to rectal diazepam for several reasons. It can provide more reliable serum concentrations and bioavailability, in addition to a simpler and less complicated route of administration. This would decrease time to seizure cessation and thus morbidity. In addition, the intranasal route provides a more palatable alternative for health care providers and parents who find rectal administration less acceptable because of the undignified nature of the procedure.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.007 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".