Medical Student Research Fellowship for Summer 2009
Mentor: Peter Szmuk, MD
Department: Department of Anesthesiology
Room number: B3304 Children's Medical Center Dallas
Mail Code: B3304
Phone number: 214-456-6404
E-mail: Peter.szmuk@UTsouthwestern.edu
Project # 1 title: Endo Pharmaceuticals - An Open-Label, Ascending, Two-part,
Single and Multiple-Dose evaluation of the Safety, Pharmacokinetics, and Effectiveness
of Oxymorphone for Acute Postoperative Pain in Pediatric Subjects: EN3203-010
Human subjects IRB approved project number: 102008-028
Project Type
Patient-based research
Brief Description of Project:
Oxymorphone hydrochloride is a semisynthetic opioid agonist derived from thebaine
with more rapid onset of action and a significantly higher analgesic potency
compared to the structurally-related compound morphine. Oxymorphone was first
synthesized and developed in the 1950s and oxymorphone-containing products were
first approved by the FDA in 1959. Up to now it was not evaluated in pediatric
patients.
This study is evaluating the safety, pharmacokinetics and effectiveness of
oxymorphone for acute postoperative pain in pediatric subjects. We plan to enroll
a total of 15 subjects in our center.
The student will participate in the subject selection, enrollment and consent
procedures and postoperatively will assist in evaluation of pain, PKA blood
sample collection and data recording.
Project # 2 title: Changes in Intraocular Pressure during Surgery in Prone Position in Pediatric Patients
Human subjects IRB approved project number (where applicable): 012008-067
Project Type - Patient-based research
Brief Description of Project:
This is a full board review, active study in which we are recording the eye
pressures a minimum of 4 instances intraoperatively during neurological surgery
cases for prone position patients.
Vision loss or impairment after spine surgery is a devastating problem with
an overall incidence variance in adult patients between 0.1 to 1 %. The incidence
of vision loss or impairment in the postoperative period in the pediatric population
is less prevalent than in adults and the exact numbers are unknown.
The IOP values and the magnitude of the IOP change over the duration of surgery
in children operated in prone position have never been measured in pediatric
patients. In consequence, we propose to determine time-dependent changes in
IOP in children undergoing prone surgery. At the time we have 21 subjects enrolled
and needing another 20.
The student will be involved in the identification of suitable subjects from
the preoperative surgery lists, will participate in the consenting process and
will help with data collection during neurosurgery. Finally, the student will
be responsible with transferring the study data in the database.
Project #3 title: Multicenter Study of Use and Complication in Pediatric Regional Anesthesia
Human subjects IRB approved project number (where applicable): 062008-064
Project Type
Patient-based research
Brief Description of Project:
The aim of this study is to collect de-identified, prospective data on the use
of regional anesthesia in pediatrics, to determine the incidence and nature
of complications of these blocks and to develop benchmark data to allow institutions
to compare their performance to an aggregate national standard. Our center is
part of this national study which intends to enroll up to 50,000 prospective
subjects (becoming the largest pediatric anesthesia study in US).
The student will be assisting the anesthesiologists performing the regional
blocks with completing the data, performing follow-up in patients with continuous
blocks (epidural blocks) and entering the data in the secure database.
Project #4 title: Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients with Difficult Intravenous Access
Human subjects IRB approved project number: 112008-041
Project Type Patient-based research
Brief Description of Project:
Even experienced clinicians fail to insert venous catheters in some patients.
Failed cannulations are uncomfortable for patients, embarrassing for the clinician,
and can delay needed medical treatments. We therefore are testing the hypothesis
that use of Vein Viewer (a new device which utilizes near infrared light and
patented technologies to illuminate subcutaneous vasculature by imaging their
location on the surface of the skin) improves cannulation success rate and decreases
the cannulation time.
The study is performed in conjunction with the intravenous nurse team at Children's.
The student will be following the IV nurse team, participate in the enrolling
process by evaluating the inclusion/exclusion criteria, record the data and
finally introduce the data in the database.
Project #5 title: Early clinical experience with the GlideScope Cobalt Video Baton in neonates and infants
Protocol is submitted for IRB approval.
Project Type
Patient-based research
Brief Description of Project:
The GlideScope video laryngoscope (Verathon Inc, Bothell, WA) is a new device
for assisting intubation that is designed to allow a view of the glottis without
the need for aligning the oral, pharyngeal, and tracheal axes.
This will be a clinical study looking into the ease and efficacy of the new
GlideScope Cobalt Video Baton for intubation in neonates and infants. The laryngoscopy
in all the consecutive cases presenting to the operating room at Children Medical
Center for general anesthesia with endotracheal intubation, will be performed
with the GlideScope Cobalt Video Baton. As outcome measurements, we will specifically
measure the time to intubation, laryngoscopic views, number of attempts, and
the success rate.
We intend to enroll 200 patients.
The student will be involved with patient enrollment, collecting the data and
introducing it in the database.