Please select the eligibility criteria that correspond to the clinical trial below.
Title: Intra-Nasal vs. Intra-Venous Lorazepam for Control of Acute Seizures in Children: Prospective Open Labeled Randomized Equivalence Trial
Brief Summary: Status epilepticus (SE) is a common pediatric emergency which is potentially life-threatening and requires rapid termination. Early and effective treatment is essential to prevent the morbidity and mortality associated with prolonged convulsive SE. Lorazepam is the standard of care for control of SE when administered by intra-venous (IV) route. The investigators intend to compare efficacy and adverse effect profile of intra-nasal vs. intravenous routes of administration of lorazepam. In resource poor settings, sometimes trained personnel or appropriate equipment for intra-venous cannulation is not available. Alternate routes of administration, if shown equivalent to conventional IV route, will be very useful in such settings or for out of hospital management of seizures in children.


Options:
A: Inclusion Criteria:

1. Age 3 months to less than 18 years;
2. Generalized tonic clonic status epilepticus, defined as:

   1. Three or more generalized tonic clonic seizures within the last hour and currently experiencing a convulsion (i.e. the current convulsion may be the third convulsion within one hour); or
   2. Two or more generalized tonic clonic seizures in succession with no recovery of consciousness between seizures and currently experiencing a convulsion (i.e. the current convulsion may be the second convulsion without recovery of consciousness after the first convulsion); or
   3. A seizure that lasts at least 5 minutes that is either generalized tonic clonic in its entirety or starts focal and then generalizes. The seizure must be associated with loss of consciousness

Exclusion Criteria:

1. Pregnancy;
2. Shock prior to study drug (sustained hypotension requiring inotropic therapy);
3. Significant dysrhythmia prior to study drug (other than sinus tachycardia);
4. Need for emergent surgical intervention and general anesthesia for a condition present prior to study drug;
5. Known sensitivity to benzodiazepines or known contraindication to benzodiazepine use; or
6. Use of a benzodiazepine within 1 week of presentation.

Certain exclusion criteria may not be known at the time of drug administration due to the need for emergent treatment. Thus patients will be terminated from the study (early terminators) if the investigators discover any of the following conditions after administration of study drug:

1. Pregnancy;
2. Use of a benzodiazepine within 1 week of presentation.
3. Parent/guardian refusal to give informed consent by the methods described;
4. Patient's refusal to assent (for patients ≥ 7 yrs old and mentally competent to understand study procedures) by the methods described, or as required by the local IRB;
B: Inclusion Criteria:

* Paramedics or reliable witnesses verify 5 minutes of either continuous seizure activity or of repeated convulsive seizure activity where the patient does not regain consciousness (operationally defined as meaningful speech or obeying commands) between seizures.
* Patient is still seizing at the time of paramedic treatment with study medications.
* Estimated weight equal to or greater than 13 kg.
* Subject to be transported to a RAMPART participating hospital.

Exclusion Criteria:

* Major trauma as the precipitant of the seizure
* Hypoglycemia (as defined by local EMS protocol or a glucose \< 60 mg/dL)
* Known allergy to midazolam or lorazepam
* Cardiac arrest or heart rate (HR) \<40 beats per minute
* Sensitivity to benzodiazepines
* Medical alert tag marked with "RAMPART declined"
* Prior treatment of this seizure with diazepam autoinjector as part of another study
* Known pregnancy
* Prisoners
C: Inclusion Criteria:

* Children presenting convulsing to the pediatric emergency or developing seizure while in casualty
* Age 6-14 years

Exclusion Criteria:

* Known hypersensitivity to any benzodiazepine
* Child has received any parenteral anti-convulsant within 1 hr prior to enrollment
* Presence of severe cardio-respiratory compromise or cardiac arrhythmias
* Presence of upper respiratory tract infection
* Presence of basal skull fracture causing cerebro-spinal fluid (CSF) rhinorrhea
D: Inclusion Criteria:

* Children aged between 2 months and 12 years
* Presenting with generalised convulsions

Exclusion Criteria:

* Any child who had received an anticonvulsant agent within 1 hour of presentation
* Seizure stopped with rapid cooling or treatment of hypoglycaemia
* Features consistent with organophosphate poisoning, hepatic or hypertensive encephalopathy

Answer: C