BME100 f2017:Group14 W0800 L3

TEAM MEMBERS

Name: Shae Diaz

Name: Kennedy Miskin

Name: David Asuncion

Name: Sean Smits

Name: Carlos Mendez-Arias

Design for Our Experiment

Gold Standards:

·Oral medication of Lorazepam

·IV Lorazepam

·Rectal Diazapam

Target sample size: 660, arrived at this number by calculating the current amount of people with epilepsy in the US (3 million) and the confidence level (5%)

To test how fast medication is getting into bloodstream:

1. Compare oral dosage of Lorazepam, IV injection of Lorazepam, rectal Diazepam, and our auto injector (LorazePen)

2. Obtain sample size (approximately 660 people)

• 500 people to be divided into three groups: one receiving IV, rectal, and auto injector (these people are epileptics, ranging from focal to generalized)
• 160 people will receive the oral dosage (these people are not actively seizing, rather they have been prescribed it for anxiety)

3. Set time intervals for which we will take blood samples to measure the concentration of medication inside the bloodstream

• Intervals (min): 1, 2, 3, 4, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 120, 240, 360, 480

• 20 total blood draws

• Maximum amount of blood to draw per person: about 3% of their total blood volume

• On average, people have 5 liters³ of blood so the average of blood allowed to draw is .15 liters¹
• It takes approximately .003 liters per blood draw to receive an accurate reading ⁴
• Take initial blood reading
• Draw blood every minute for 5 minutes, then every 5 minutes for an hour
• Draw blood once it has been 2 hours for every two hours until total time has reached 8 hours (this will show how long the drug lasts in the bloodstream)

Factors to consider: The average ambulance response time is 6 minutes and 35 seconds, which means that someone who is having a seizure has to wait 6 minutes before paramedics even arrive on the scene to start an IV or other form of treatment.²

To test how quickly seizure dissipates:

1. Compare IV Lorazepam, rectal Diazepam, and our auto injector (LorazePen)

2. Obtain sample size (660 people: all epileptics, ranging from focal to generalized)

• 220 receiving IV Lorazepam
• 220 receiving rectal Diazepam
• 220 receiving auto injector (LorazePen)

3. When someone in this experiment has a seizure, they can only receive the kind of the treatment of their group

• For IV Lorazepam (2 mg/1 mL) ⁵
• For rectal Diazepam (.2 mg/ 1 kg) ⁶
• For autoinjector (LorazePen) (2 mg/1 mL) ⁵

• Same dosage as IV

4. Time how long it takes for someone to stop having a seizure once the treatment has been administered

Factors to consider: The average ambulance response time is 6 minutes and 35 seconds, which means that someone who is having a seizure has to wait 6 minutes before paramedics even arrive on the scene to start an IV or other form of treatment.²

References

1. Dr. Greene, “How Much Blood is too Much Guideline”. https://www.drgreene.com/blood-guideline/

2. DC Fire and EMS Department, “Average Response Time to Emergency Scenes Improves”. https://fems.dc.gov/release

3. Elert, Glenn, “Volume of Blood in a Human”. http://www.webcitation.org/mainframe.php

4. EthnoMed, "How Much Blood is Taken?", https://ethnomed.org/patient-education/blood/how-much-blood-is-taken-spanish-english

5. Medscape, "lorazepam", http://reference.medscape.com/drug/ativan-loraz-lorazepam-342906

6. Medscape, "diazepam", http://reference.medscape.com/drug/valium-diastat-diazepam-342902