1. Principal Investigator
2. Appointments at The RSD / CRPS Treatment Center and Research Institute
3. Laboratory Tests
4. Travel Preparation
5. Breakthrough Pain: Non-Narcotics
6. Other Information
Hotels near The RSD/CRPS Treatment Center and Research Institute
Typical fees for research study
7. Related Videos
8. New Patient Information Form
1. PRINCIPAL INVESTIGATOR:
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):
San José Hospital
Technological of Monterrey
School of Medicine
The Ketamine Coma Study is supervised by Dr. Cantu who makes the final determination if a patient qualifies for the study.
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:
2. APPOINTMENTS AT THE RSD/CRPS TREATMENT CENTER AND RESEARCH INSTITUTE :
Clinic appointments are scheduled at: 813 995-5511
If you are here just for an evaluation as a new patient = 0ne day
If the evaluation suggests that you are a candidate for the ketamine study = Two days in Tampa
Day 1 = New patient evaluation
Day 2 = Interview about the study and baseline measurements for study. This evaluation will be recorded on video. (No charge for day 2)
The following videos will give you an idea of what to expect on Day 2:
Bring your medical records and the New Patient Information Form to the evaluation on Day 1.
How long do you need to be in Florida?
1. The initial evaluation on day 1 takes 2 - 3 hours.
2. The research evaluation on day 2 takes 1 -3 hours with a video recording. The Research Consent Form and Protocol will be discussed on day 2. Below is a link to the English version of the consent form for the Ketamine Study.
There is no charge for the research evaluation on Day 2.
3. On Day 2 you will need to be evaluated by our Psychologist (Dr. Richard Hoffman) for 2 - 3 hours to determine your baseline mental function before the research study. The cost for this evaluation is $100. It is your responsibility to schedule your appointment with Dr. Hoffman's office at: 813-977-2924.
3. REQUIRED LABORATORY TESTS IN USA
Typical labs completed in the USA prior to the study include:
Thyroid Panel (TSH)
Venous doppler of the legs to rule out deep vein thrombosis
4. TRAVEL PREPARATION
Typical items to acquire in the USA prior to the study include:
Sedative for travel by air (e.g., Xanax, Ativan, etc)
Contact Information for all people traveling with patients, while in Mexico, 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:
___________________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,_____________(family member or friend), will need to accompany the patient at all times to insure her safety. Therefore, (family member) will require an emergency passport as well. Feel free to contact me at 813 435-8206.
Anthony Kirkpatrick, MD, PhD
My patient _______________ 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.
Follow-Up Evaluations in Tampa are Required:
It is essential that research subjects return to Tampa after the ketamine coma procedure for evaluations as stated in the CONSENT they signed before they entered the study.
Research subjects will be evaluated by Dr. Kirkpatrick at 1 month, 6 months, 12 and 24 months.
CONSENT .... Click Here
Prior to entering the ketamine coma study, research subjects need to write a check payable to the International Research Foundation for RSD / CRPS for the cost of three round trip tickets to Tampa for two people.
When they appear for the 12-month follow-up testing per the CONSENT they signed, the money will be returned.
If the research subject does NOT return for evaluation, the money will be donated to the Foundation.
This deposit is a means to insure research subjects understand the importance of follow-up evaluations to the research.
5. Breakthrough Pain: Medications & Ketamine Boosters :
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.
1. Use of Non-Narcotics (Non-Opioids)
The following combinations of drugs are useful for treating acute pain:
A. Alternating doses of Tylenol (acetaminophen) with ibuprofen, or:
B. Alternating doses of Tylenol (acetaminophen) with Celebrex (celecoxib).
i. Alternating with Tylenol will tend to decrease the risk of stomach problems associated with ibuprofen and Celebrex.
ii. All three of the pain medications suppress fever. That might make the patient feel better but will tend to mask the early sign of an infection.
Do NOT exceed the maximum recommended doses of Tylenol, ibuprofen and Celebrex:
Tylenol: 650 mg every 4 hours (Do not exceed 4 grams per day).
Ibuprofen: 800 mg every 8 hours.
Celebrex: Loading dose 400 mg and then 200 mg every 12 hours.
NOTE: Use of Celebrex
Evidence suggests that Celebrex has an advantage over other pain medications of preventing RSD following surgery
2. Use of Opioids (Narcotics):
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.
Ketamine Treatment Protocol ... Learn More
1. Wilson GR, Reisfield GM. Morphine hyperalgesia: a case report. Am J Hosp Palliat Care. 2003;20:459-461.
2. Li X, Angst MS, Clark JD. Opioid-induced Hyperalgesia and Incisional Pain. Anesth Analg. 2001;93:204-209.
3. Vanderah TW, Suenaga NMH, Ossipov MH, et al. Tonic descending facilitation from the rostral ventromedial medulla mediates opioid-induced abnormal pain and antinociceptive tolerance. J Neurosci. 2001;21:279-286.
4. Angst MS, Koppert W, Pahl I, et al. Short-term infusion of the mu-opioid antagonist remifentanil in humans causes hyperalgesia during withdrawal. Pain. 2003;106:49-57.
3. Ketamine Boosters:
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.
Treatment of breakthrough pain due to RSD / CRPS is an accepted treatment by all insurance companies.
For over 30 years, treatment of breakthrough pain with IV ketamine at doses up to and including those doses required for general anesthesia have been approved by the Food & Drug Administration (FDA).
Therefore, insurance companies are obligated to reimburse patients for customary and usual cost for the treatment of breakthrough pain with IV ketamine without further delay pursuant to PPO contracts.
If you believe your insurance company is underpaying you for out-of-network treatment with ketamine, please visit the following site:
Reimbursement for Ketamine Treatment
6. OTHER INFORMATION:
The RSD / CRPS Treatment Center and Research Institute:
1910 East Busch Boulevard
Tampa, Florida 33612
A list of hotels and their discounted rates can be found at the link below:
Patients 18 years and younger can stay with their family for free at the:
Ronald McDonald House
For reservations, call Betsy Wilkinson at 813 254-2398, ext: 314
Typical fees for research study effective December 14, 2007.
Anthony Kirkpatrick, MD, PhD