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Fernando Cantu MD is the Principal Investigator for the Ketamine Coma Study in Mexico. His study has been approved by his Institutional Review Board (IRB):

The Ketamine Coma Study is supervised by Dr. Cantu who makes the final determination if a patient qualifies for the study.

THIS RESEARCH STUDY HAS NOT BEEN APPROVED BY THE INSTITUTIONAL REVIEW BOARD AT THE UNIVERSITY OF SOUTH FLORIDA. NEITHER DR. KIRKPATRICK NOR THE UNIVERSITY OF SOUTH FLORIDA ARE PARTICIPATING IN OR CONTROLLING THE MEXICO RESEARCH.

The information below is for patients of Dr. Kirkpatrick that might be part of Dr. Cantu's research studies. The doctors and researchers at San José Technological Hospital of Monterrey, School of Medicine, study illnesses and other health problems. They try to find the best ways to resolve these health problems. In order to do this, they need help from referring doctors of patients who agree to be part of the research study.

Dr. Kirkpatrick might suggest Dr. Cantu's research as an option for certain patients with RSD / CRPS. Dr. Kirkpatrick will attempt to assist Dr. Cantu with the following arrangements:

If the evaluation suggests that you are a candidate for the ketamine study = Two days in Tampa

Day 2 = Wednesday ~ Interview about the study and baseline measurements for study. This evaluation will be recorded on video. (No charge for day 2)

2. THE RESEARCH EVALUATION ON WEDNESDAY TAKES 1-3 HOURS WITH A VIDEO RECORDING. THE RESEARCH CONSENT FORM AND PROTOCOL THAT WILL BE DISCUSSED ON DAY 2. HERE IS A LINK TO THE ENGLISH VERSION OF THE CONSENT FORM FOR THE KETAMINE STUDY:

3. ON THURSDAY YOU NEED TO BE EVALUATED BY OUR PSYCHOLOGIST (DR. RICHARD HOFFMAN) FOR 2-3 HOURS TO DETERMINE YOUR BASELINE MENTAL FUNCTION BEFORE THE RESEARCH STUDY. YOU NEED TO SCHEDULE AN APPOINTMENT WITH DR, HOFFMAN FOR THURSDAY – PHONE; 813 977-2924

Contact Information while in Mexico for all people traveling with patients needs to be provided to Dr. Fenrnando Cantu and Dr. Anthony Kirkpatrick

Physician's Letters for Airport Security and Ketamine Booster Infusions: See below for typical letters:

Draft Airport Security Letter

April 1, 2007

U.S. Department of State

Subject: Request for Emergency Passports

TO WHOM IT MAY CONCERN

Dr. Shannon Stocker MD is my patient with open ulcers on her arms due to her advanced complex regional pain syndrome (RSD / CRPS)

Ulcers due to RSD were reported by Dr. Robert Schwartzman more than 15 years ago:

Webster G, Schwartzman R, et. al. Reflex sympathetic dystrophy: Occurrence of inflammatory skin lesions in patients with Stage I and II disease. Arch Dermat 1991 127: 1541-44.

Infection due to RSD-induced skin ulcers can lead to multiple extremity amputations as a result of life-threatening septicemia. So far, all patients have showed improvement in skin ulcers following the 5-day ketamine coma procedure.

Please grant an emergency US Passport in order for my patient to travel to Monterrey, Mexico for treatment. Failure to do so will increase the risk of amputation.

Please be advised that these ulcers are extremely painful and sensitive to light touch (allodynia). Also, the patient’s husband (Greg) will need to accompany the patient at all times to insure her safety. Therefore, Mr. Stocker will require an emergency passport as well.

Feel free to contact me at 813 974-2870 or 813 390-8690 if you require additional information.

Sincerely,

Anthony Kirkpatrick, MD, PhD

ALTERNATE DRAFT

Medically Necessary:

My patient Deborah Caloutas has a medical condition called complex regional pain syndrome. Light touching of the skin can cause unbearable pain (allodynia)and muscle cramps. Preferential seating is required and security workers need to be cautioned about the patient’s medical condition. If there is an opening, please provide FIRST CLASS seating. If FIRST CLASS is not available, please seat family behind the bulkhead with the patient near a window.

Research subjects should expect acute pain to be caused by the ketamine coma procedure. Soreness of the throat due to the 5-day intubation and back pain due to being immobilized flat on the back are relatively common sources of acute pain. The acute pain due to the ketamine coma procedure is not RSD pain. Acute pain due to the ketamine coma procedure responds more favorably to certain types of pain medications than RSD pain.

Do NOT exceed the maximum recommended doses of Tylenol, ibuprofen and Celebrex:

Evidence suggests that Celebrex has an advantage over other pain medications of preventing RSD following surgery:

Many patients are weaned painlessly from narcotics (opioids) while under general anesthesia during the 5-day ketamine coma procedure.

During recent years, it has become increasingly clear that long-term or escalating opioid use does not lead to improvement of function in every patient. Case studies of pain report that opioids actually increase pain in some patients as a consequence of injury or surgery, often associated with a modification of the pain character and an extension of the affected region that may persist for days, weeks, or even years.[1-2] Theories suggest that opioids can induce central sensitization, causing or aggravating preexisting pain. This phenomenon has been reproduced in experimental settings in both humans and rodents, where thermal hyperalgesia, mechanical allodynia and increased pain behavior in the formalin test are manifest not only during opioid withdrawal, but also during ongoing opioid administration, lasting several days.[3,4]

It is preferable, therefore, to use IV ketamine with a sedative such as midazolam or propofol to control severe breakthrough pain following the ketamine coma procedure.

A trial of opioid therapy may be indicated for patients who have failed to respond to a reasonable trial of nonpharmacological and nonopioid modalities. The trial must document the patient’s pain and function as dose titration progresses. The treatment of pain is guided by the premise that each patient is unique in his perception of pain and in his response to medications. Accordingly, the patient's response is the ultimate guide to treatment. Maximized pain relief may be achieved by incorporating an understanding of the pain type, utilizing systematic and disciplined medication trials, and frequent reassessment and monitoring of the patient.

Insurance Authorizations for Treatment with Ketamine:

Patients should not use the word "research" with regard to the administration of ketamine – unless the use of ketamine is part of a research study.

Some insurance companies might refuse to provide adequate reimbursement to physicians and health facilities for treatment of break through pain with ketamine.

Ketamine is a drug approved for pain control by the FDA for over 30 years. Pain management is an approved treatment for RSD / CRPS.

At the following link is a report published by experts on the treatment of RSD / CRPS with ketamine:

http://www.rsdfoundation.org/en/Ketamine_Treatment.html

Modalities	Yes	No	Effectiveness
Blocks
TENS
Physiotherapy
Biofeedback
Counseling
Pain Management
Surgery
Other

Drugs	Dosage	Purpose	Effectiveness	Doctor

Drug	Effectiveness	Side Effects