Principal
Investigator:
P.I.: Rachel Stanley, MD,
MHSA
Study Abstract
(brief description, 3 - 5 sentences), including "short name of
the study":
Ativan/Seizure Study
This is a pharmacokinetic study of lorazepam/Ativan in pediatric patients
diagnosed with seizure disorder. Patients that receive Ativan as standard
of care and enroll in the study will have an overnight stay in the
Emergency Department have a series of blood draws during the next
48 hours (Cohort 1). Subjects may also be provided with a free Medic-Alert
bracelet. Children with previous exposure to Ativan but not currently
experiencing seizures may enroll in another study group, and receive
an elective dose of Ativan and a series of blood draws during an overnight
visit to the GCRC (Cohort 2). Guardians of enrolled children will
be contacted for a telephone follow-up interview 7-10 and 30-40 days
after the study visit. The University of Michigan is one of 10 sites
in the Pediatric Emergency Care Applied Research Network (PECARN)
participating in this study.
IRB#
and approval date:
2004-1017, Approval Date: April 21, 2005 Study
Start and End Dates:
Start date: July 18, 2005 and End Date:
December 2005
Inclusion criteria:
1. Ages 3 months to less than 18 years.
2. Prior known exposure to lorazepam.
Exclusion criteria:
1. Parent/caretaker refusal or inability to obtain informed consent
by the methods described.
2. Patient’s refusal to assent (for patients aged = 7 yrs).
3. Weight <6.0 kg for Cohort 1 or weight <8.5 kg for cohort
2
4. Inability to insert indwelling intravenous catheter for blood
sampling.
5. Pregnancy
6. Sustained hypotension (> 10 minutes of BP below the fifth
percentile for age) at time of examination.
7. Significant arrhythmia (other than sinus tachycardia) at time
of examination.
8. Known sensitivity to lorazepam, severe adverse reaction or known
contraindication to lorazepam use.
9. Use of lorazepam within 4 days of study drug dosing.
10. Subjects that are American Society of Anesthesiology (ASA) Class
greater than 2, unless the reason for higher ASA Class is solely
their epilepsy or status epilepticus. (For Cohort 2, ASA class 1
is required unless the reason for higher ASA Class is solely their
epilepsy)
11. Age-specific hemoglobin below the normal limit.
12. Significant renal or hepatic disease as evidenced by laboratory
abnormalities greater than twice the upper limit of normal for liver
enzymes (Cohort 2 only)
Names of staff working on study,
including beeper and telephone number:
Rachel McDuffie, MPH
Pager 1368
Will any test be charges to the
study? If yes, please list and provide billing information.
Yes – all blood draws completed for study purposes will be
charged to the research account.
No study procedures (i.e. beyond standard of care) will be billed
to patient’s insurance company.
Patients will be compensated for any 24-48hr return visits (both cohorts),
and for the overnight GCRC visit (Cohort 2 only).
Is
the subject having tests and procedures done that will be relevant
to their care in the ED or follow-up from the ED? If yes, what are
the tests/procedures? Who will be responsible for interpreting those
results and reporting them to the patient and , if appropriate, providing
recommendations for follow-up?
All subjects will receive
regular monitoring including vital signs w/lead II ECG, aspiration
exams and safety labs. If the assessment of any study data indicates
a reason for concern, the Principle Investigator (Rachel Stanley,
MD, MHSA) will follow-up with patient and patient’s caregiver(s)
and provide a referral if appropriate.
|
