THIS FORM IS PROVIDED ONLY AS A GUIDE TO HELP YOU FORMULATE THE QUESTIONS YOU MIGHT HAVE WITH RESPECT TO THE RESEARCH STUDY.
February 11, 2007
Revised: December 13, 2006
Revised: October 9, 2006. Based on the entry of Steve Altmiller (CEO of the San Juan Regional Medical Center in USA and father of the first patient in the study at San José Hospital)
San José Hospital
Technological of Monterrey
School of Medicine
This information is for persons that might be part of the Research Studies.
The doctors and researchers at San José Technological Hospital of Monterrey, School of Medicine, study illnesses and other health problems. We try to find the best ways to resolve these health problems. In order to do this, we need help from the persons who agree to be part of the research study.
Title of the Research study:
A Pilot Study of Ketamine Infusion during 5 days for the Non-treatable Complex Regional Pain Syndrome (CRPS)
Person in charge of the Study:
Dr. Fernando Cantú Flores, Anesthesiologist and specialist in pain management. Monterrey, México.
Anthony Kirkpatrick, MD, PhD, Anesthesiologist and specialist in Pain management from South Florida University, Tampa, Florida USA
Richard Hoffman, PhD, Clinical Psychologist, Tampa, Florida, USA.
Thomas Freeman, MD, Neurosurgeon, South Florida University, Tampa, Florida, USA.
Contacts for information:
Dr. Cantú may be contacted in Monterrey, México, cell phone 011-528-18-259-1023.
Dr. Kirkpatrick may be contacted in Tampa, Florida, USA. at telephone 813 995-5511. Pager and cell phone numbers will be made available to research subjects and family.
Dr. Hoffman may be contacted in Tampa, Florida, USA at telephone 813 977--2924. Cell phone number will be made available to research subjects and family.
Dr. Freeman may be contacted in Tampa, Florida, USA, at telephone 813 259-0889
Study personnel who can act in name of the person in charge:
Dr. Javier Valero Gómez, Medical Director, San José Hospital, may be contacted at telephone 011-528-18-389-8306.
Other staff members: You can expect the following staff members to be in continuous contact with you during the study:
Richard Hoffman, PhD (Clinical Psychologist), Tampa, Florida USA.
Dr. Anthony Kirkpatrick, MD, PhD, Anesthetist and specialist in Pain Management, South Florida University, Tampa, Florida USA.
Dr. Javier Valero Gómez, Medical Director and Director of Patient Safety of the San José Technological Hospital, of Monterrey
Dr. Fernando Castilleja
San José Technological Hospital of Monterrey, Mexico
Dr. Rodolfo J. Treviño Pérez,
Pediatric Critical Care
San José, Technological Hospital of Monterrey
Where will the study take place?
San José Technological Hospital of Monterrey
Who is paying for the study?
All the medical expenses related to the study will be the responsibility of the subject (patient) taking part in the study.
Should you take part in this study?
This form gives explanations about this research study. You can decide if you want to be part of it. You do not have to be part of the study. This form will help you decide if you want to be part of it. If at any moment you have any question, feel free to ask the person who is explaining this study to you.
Before you decide:
- Read this form
- Talk about this study with the doctor conducting the study or the person who explains the study to you. You may be accompanied by someone else while the study is being explained to you.
- Find out what the study is about
This form explains:
- The purpose of this research study.
- What will happen during this study and what you will have to do?
- The potential benefits of being part of the study, if any.
- The risk of having problems due to taking part in the study.
- The answers to any questions you might have.
You may ask questions:
- You might have questions that this form does not answer. If you do have them, ask the doctor conducting the study, at any time.
- You do not have to guess things you do not understand. Ask the people that are conducting the study to explain things in a way that you can understand them.
After reading this form you may:
- Take your time to think about the information that has been given to you.
- Ask a friend or family member to read the form.
- Talk about it with the doctor who is treating you.
It depends on you. If you decide to be part of the study, then you can sign the form. If you do not want to be part of this study, do not sign the consent form.
Why is this research being done?
The purpose of this research is to find out if an anesthetic called Ketamine helps in the treatment of the Complex Regional Pain Syndrome (CRPS). Ketamine has been used in thirty (30) patients in Germany. Nine of 30 patients (30%) have experienced pain relief that was not obtained by treatments used before. One of these patients has obtained complete pain relief during nine years and the others for more than five years.
Of the other 21 subjects (70%), all of who obtained at least partial pain relief, seven (7) were completely without pain during six to seven months. After that, the pain slowly returned.
Ten of the patients (33%) are being currently treated with low doses of ketamine in an effort to increase the initial effect.
If you agree to be part of this study, you will be given two drugs: Ketamine and Midazolam that will put you to sleep. You will be asleep during five days by means of continuous infusions (a quantity will be given continuously but slowly) of these drugs. At the end of the five days the drugs will be stopped and you will wake up. After the treatment you will take several tests to see if the treatment worked completely, partially, or not at all. You will have more tests every certain number of months during two years in order to observe how long the effects of the treatment last.
Ketamine is a drug approved by the FDA in the United States for use in general anesthesia. Ketamine has not been accepted by the FDA for use in the treatment of CRPS.
The 5 day Coma is a high risk experiment
Why are you being ask to be part of the study?
We are asking you to be part of the study because you have CRPS and every reasonable treatment to help your condition has failed. We want to find out if this treatment will help persons who have CRPS.
For how long will you be asked to be part of the study?
You will be asked to be part of the study for two years more or less. The initial treatment will last five days, but we want to follow up with your progress for a long time to see if the effects of the treatment last a certain time and to make sure that you are well.
The visit during the first month:
Neuropsychological studies that test cognitive function will be done before the ketamine infusion and one month after being released by HSJ. The subjects will be evaluated as outpatients by Dr. Kirkpatrick and Dr. Hoffman in Tampa, Florida. Side effects of ketamine which include dizziness, muscular weakness, fatigue, and anxiety will be documented during the patient visit. Use of opiates by patients (including those used through intrathecal infusion morphine pump) for pain management, will be documented before study participation and one month after the study. Patients will be monitored in order to evaluate changes in their everyday activities. They will be asked to evaluate their social and professional rehabilitation as complete, significantly better, unchanged, slightly worse, or significantly worse, during the outpatient visit.
Follow-up at two years:
The patients will be evaluated by Dr. Kirkpatrick at 1 month, 6 months, 12 and 24 months to evaluate the following clinical parameters:
The patient will be asked to evaluate if their social and professional rehabilitation is complete, significantly better, unchanged, slightly worse, or significantly worse.
How frequently will you have to come to the study visits?
One of the study visits is with the co-researcher Dr. Anthony Kirkpatrick, PhD. This visit is different from the visits you have with your regular doctor. You will have 2 study visits.
The first visit is to evaluate you before you participate in the study. Dr. Kirkpatrick and Dr. Hoffman will do some tests related to the research. The tests that will be conducted are to see if you can participate in the study. They are also to measure your symptoms (pain, range of movement, and your ability to think clearly and to do simple tasks).
Before your first study visit you will be given a copy of this CONSENT and will be required to read this document carefully. The first study visit should not take more than a few hours with Dr. Kirkpatrick and Dr. Hoffman.
This study visit will include a discussion of the necessary care after you have been admitted to the hospital. You will stay in the hospital in the intensive care unit during five days. You might need a longer stay in the hospital, depending on your condition after the treatment. In the study in Germany, the total stay in the hospital was between 7 and 9 days.
During your stay in the hospital, you will have blood analysis and x-rays done every day to make sure you are well.
The follow up visit after a month will last about three hours. This visit will take place at Dr. Kirkpatrick and Dr. Hoffman’s office in Tampa, Florida. You will be evaluated as an outpatient the first month. Therefore, if the admission to the hospital is considered as a visit, there will be a total of three visits. During all these visits, the doctor will give you several tests to complete. Some of these tests are to see how well the infusion worked; others are to make sure that you are well. You will not have to give a blood sample in the follow up visits. The psychological test will be done only in the first visit of the study and in the first month visit.
Patients will be evaluated to observe changes in their everyday activities. During their visit, they will be asked to evaluate their social and professional rehabilitation as complete, significantly better, unchanged, slightly worse, significantly worse. Patients will have to contact Dr. Kirkpatrick at 6 months, 12 months and 24 months to evaluate these clinical parameters.
How many other people will be part of the study? Approximately 14 people will be part of the study in the San José Technological Hospital, Monterrey, México.
Will the medical treatment you receive from your primary doctor change if you are part of this study?
The kind of treatment you are now receiving from your regular doctor will not change as a result of being part of this study. You will continue your visits with your regular doctor. If the study treatment does not help your CRPS, your regular doctor will give you the same kind of treatment that you would have anyway.
If you need to, you can
- Use other prescribed medicines that will help your illness.
- Consider any surgery you might need.
Talk to your regular doctor about the treatments you might need.
If you have an emergency you may obtain care for the emergency.
Other treatments for CRPS may be used. If you need the additional treatment for your CRPS after the study treatment period, you may receive it from your regular doctor. Besides, you can notify Dr. Kirkpatrick or Dr. Cantú about your treatment.
What other options do you have if you decide not to be part of this study?
If you decide that you do not want to be part of this study, that is fine. There are other options, like physical therapy (special exercises), drugs to help with your pain and inflammation (swelling and redness), injected medications to block the nerve actions that are causing you pain and surgery. To be a candidate for the study, you must already have received most or all these treatments.
How can you start?
- First, we will ask for your permission to be filmed during the consent process. If you accept, you will sign a release for the video film and the informed consent process will begin. The film will be used to document your physical limitations before the infusion of ketamine and one month after the infusion. While you are unconscious during 5 days in the ICU, someone independent from the study staff (for example, a family member) will be assigned to act as your legal representative. You will be offered a DVD production called “Perspective of a Volunteer about ketamine research” that lasts about 32 minutes approximately. This video could help you to better understand the study.
- You have to inform your treating doctor that you will be part of the study.
San José Hospital (HSJ) has outlined the following financial obligations:
- Before filling out the hospital admission, you will make an appointment with a financial advisor to make arrangements for the payment of your fees. This person may be contacted by asking Dr. Cantú. The HSJ financial advisor assumes the primary responsibility of explaining the hospital charges to you.
Financial options that San José Hospital has for patients:
- One LUMP amount of $32,000 US dollars.
- This includes: hospital costs, the first Ketamine reinforcement, and the medications as well as medical fees.
- The amounts may change, by written notification, either by e-mail or any other means of communication.
- Hospital San Jose reserves the right to increase or decrease the fee for each individual participating in the investigation. This will take place only with previous advice to the patient BEFORE being admitted to the hospital for the study and before signing the consent forms.
- The expenses of any complication will be covered by this amount.
- The patient makes a prepayment of $22,000 USD, but at the end of the service he/she must pay the total amount of the invoice with a discount according to the following:
- High-risk patients with an anticipated longer stay in the hospital will be asked for a higher deposit.
- The expenses of any complication will have to be covered by the patient.
- In this option, the Doctors services are NOT included with the Hospital’s bill. The amount of $9,000 US dollars must be prepaid, without discount.
- The amount of $9,000.00 dollars will cover all the Doctors expenses for the first ten days.
Declaration of injuries at HSJ
In the case of an injury or illness as a result of being part of this research study, please consider that you will have immediate medical treatment for short-term injuries or illness. The cost of the medical treatment that is not covered by your insurance, government program or study sponsor will be added to your bill. No other compensation will be offered.
Additional visits related to the study may incur in travel expenses and minor aches and pains.
We will perform these tests:
You will be given a standard group of written and verbal tests to evaluate your capacity to answer questions and do certain tasks. Some of the tests involve written answers, some involve the drawing of basic shapes, touching your fingers one after the other, or connecting dots.
This visit for the evaluation tests will take about three hours. Then you and the research team will decide if you will or will not be part of the study.
Laboratory Data Gathering before the Study: The patient must have the following tests before arriving in Mexico. The cost of the tests will be the patient’s responsibility:
- A Basic metabolic panel( electrolytes, Urea Nitrogen in the blood, Ca, Na, Creatinine, glucose), BH, hepatic enzymes, CPK, EGO (collected in a sterile container)
- Thorax X-ray and EKG
- Doppler Ultrasound test before treatment to verify normal flow in vein system.
- Chronic smokers: patients older than 30 years are excluded from the study. Subjects of the research of 30 years or younger must try to stop smoking and must have a “Simple Spirometry”. This test is necessary before evaluating the patient for the CRPS treatment. The test may be offered in most hospitals. The patient must call their local hospital and ask for the Lung Function Lab. The process in the USA has the code # 94010 and it costs approximately $378 US dollars. If you have any question, ask your pneumologist (lung specialist) to call Dr. Kirkpatrick.
What will you have to do in order to be prepared for this study?
After the evaluation tests: You and the study doctor will set a date for your study participation. If your pregnancy test is positive, you will not qualify to participate in the study.
Your part in the ketamine infusion will last at least five days and you will be staying at the hospital at least two additional days, so you will have to plan being in the hospital for at least a week.
You might have to temporarily stop the intake of some of the medicines you are now taking before you are admitted to the hospital for the treatment. This may include one or more of your medicines against pain. Dr. Kirkpatrick will tell you what medicines you may continue taking and the ones you will have to stop taking.
The morning of your treatment visit, you may not eat or drink anything after midnight. Your stomach must be empty before you can safely receive the study treatment.
What will happen during this study?
The day of the study treatment you will be admitted to San José Hospital (HSJ) in the Intensive Care Unit (ICU). HSJ reserves the right to end the study at any moment for your safety. The HSJ has the right to modify the costs in order to reimburse your money in case it stops your treatment.
To begin treatment, two catheters (a tube for intravenous liquids) will be inserted in your arm veins. The intravenous treatment will be used to take blood samples to monitor your health. They will also be used to administer the drugs. At the beginning of the infusion, you will receive two drugs through the IV line, ketamine and midazolam. These drugs will put you to sleep. You will receive another drug in order to relax your muscles called succinylcholine. This third drug is to make it safer and
easier for the doctor to introduce the breathing tube. After putting in the breathing tube, it will be connected to a machine that will help you breath. The introduction of the breathing tube and the use of the machine to help you breathe are required because you will be receiving large doses of these drugs that will not allow you to breathe completely on your own. This is called general anesthesia.
While you are under general anesthesia another catheter will be put in an artery in your wrist. This will be used to measure your arterial pressure and take blood for tests. Another two tubes will be used, one in your stomach to feed you and another one in your bladder to help you pass urine.
Clonidine may be given through the stomach tube. The Clonidine belongs to a type of medicines that can protect against the toxic effects of the ketamine in your nervous and circulatory systems.
Every day in the ICU you will have many tests done on you. Blood samples will be taken to see how well you are breathing, in order to verify the amount of oxygen in your blood, and to see how well your kidneys and liver are working. A thorax X-ray will be taken every day to make sure that your lungs are healthy. Many tests will be done in order to verify your CRPS symptoms. This will include your skin temperature verification, the amount of inflammation and the color of your skin. The nursing staff of the ICU will verify the depth of your sleep at regular intervals.
The quantity of ketamine and midazolam that you are receiving may increase slowly during the five days of your stay at the ICU. The reason for this increase is to make sure that you remain under general anesthesia.
When the five days of general anesthesia are over, the quantity of ketamine and midazolam that are given to you will be decreased slowly until you begin to wake up. The study doctor will make sure that you can breathe by yourself and can follow simple instructions such as raising your head and opening your eyes before the breathing tube is taken off. This is for your safety.
After you wake up, the study doctor will perform several tests to see how well the general anesthesia has worked. Some of these tests are simple questions, some are written and some are both written and verbal. You will be released from the ICU and transferred to a regular hospital room when the study doctors consider that it is safe for you to be transferred. You may spend two or more additional days at the hospital before you are allowed to go home, just to make sure that you are well. You will also be asked about any side effects that you might be having due to the general anesthesia. You may obtain treatment for these side effects before and after you go home.
After you are released from HSJ you will be evaluated as an outpatient in one month by Dr. Kirkpatrick and Dr. Hoffman in Tampa, Florida.
During this study visit, you will take the same neurological, physical, and pain tests you took before you were hospitalized as well as other services and tests related to your CRPS symptoms.
You may call the study doctor, Dr. Cantú or Dr. Kirkpatrick, whenever you want during the study period if you have questions about your condition, at the telephone numbers listed previously.
During this study you will need:
To schedule and go to the appointments with the study doctor for evaluation. After the study treatment, you will have to take several tests, both written and verbal during each visit.
Will you be paid for being part of this study?
We will not pay you for the time you will be in the study as a volunteer.
How much will it cost you to be part of this study?
It will cost you a great amount of money to be part of the study.
The study will pay the standard psychological tests to evaluate the treatment and how well you can perform several tasks. These tests are only available by a doctor’s order, and cannot be shown to you before you participate in the study.
You will have to make prepayment arrangements to HSJ according to the selected option to cover your medical expenses. If you have any questions about your financial obligations for this study, you should direct your questions and concerns to your assigned case financial advisor. The HSJ has assumed the primary responsibility to provide this information.
What are the potential benefits if you are part of this study?
We do not know if you will obtain a health benefit if you are part of this study. We do not know if the therapy with ketamine will help alleviate the symptoms of CRPS. That is why we are doing this study. This research study will help us know if the therapy with ketamine is helpful for CRPS.
Besides that, we will learn more about CRPS, we will learn more about what helps and what does not help. What we learn may help others with CRPS.
What are the risks if you are part of this study?
The treatment might not be of any usefulness.
At this moment we do not know with certainty if it will help. If it does not help, your condition/illness could get worse.
Can there be side effects?
You might have problems due to the use of general anesthesia with ketamine in this study. These problems are called side effects. Some of the side effects are just bothersome. Others could be harmful. There might be some side effects that we still do not know about.
These are the known side effects that might occur with the general anesthesia treatment:
- Lung infections, for example pneumonia.
- Infection of urinary tract and kidneys.
- Infections of the body due to the invasive procedures such as the insertion of tubes in veins, arteries, trachea and stomach.
- Prolonged dependence in a breathing machine that supplies oxygen to your lungs. `
- Injury to the trachea due to insertion and removal of a breathing tube.
- Blood clots in extremities and lungs.
- Injury to your arteries due to the insertion of a catheter line in the arteries.
- Unexpected allergic reaction to drugs used in the study.
- One possibility is consciousness and the ability to remember during the general anesthesia with ketamine.
- Gastrointestinal imbalance and/or discomfort and muscular weakness due to prolonged general anesthesia. Constipation can be a serious problem.
- Loss of weight and normal appetite, and abnormal sweating associated with the sensation of heat for a month or more after the five days general anesthesia with ketamine. Abnormal sweating may be related to sensations of heat throughout the body.
- Re-injury that would lead to the activation of the CRPS symptoms after 5 days of general anesthesia with ketamine.
- If there are benefits of the coma with ketamine study, these benefits may not be felt until weeks or months later.
- The hospital stay without complications is between 7 and 9 days.
Specific side effects of ketamine include:
Uncomfortable reactions have occurred in about 12 percent of patients. The psychological manifestations vary in intensity from pleasant states, similar to sleep, to imaginary vivid hallucinations and delirium during the emergency. In some cases these states have been accompanied by confusion, excitement, and irrational conduct that some patients remember as an unpleasant experience.
Generally it does not last more than a few hours. But in some cases, recurrence has taken place 48 hours after having been given ketamine. There is no known permanent residual effect as a result of the use of ketamine.
Incidence of these emergency phenomena are less in young patients (15 years of age or less) and older (more than 65 years of age). Incidence also lessens when the doctor has more experience with the medicine.
The incidence of psychological manifestations may decrease during the emergency, particularly observations such as dreaming and delirium, using ketamine in conjunction with midazolam.
THE HEART AND THE CIRCULATORY SYSTEM
Frequently arterial pressure and cardiac frequency increase after having been administered only ketamine. Oral clonidine is a drug for arterial pressure that controls high blood pressure. Even so, a decrease in arterial pressure and cardiac frequency has been observed. Irregular cardiac beat has also occurred.
Even though breathing is frequently stimulated, a severe breathing depression or a failure in breathing may occur after high doses of ketamine. Spasms of the vocal cords or other kinds of airway blockage have occurred during general anesthesia with ketamine.
Abrupt movements of the eye (nistagmus) have been observed after administering ketamine. The side effect of nistagmus is minimized by informing the patient and family that these eye movements are expected and that double vision may occur. Ketamine may also cause a slight elevation of pressure inside the eye.
THE NERVOUS SYSTEM
In some patients, an increase in the muscle tone may manifest itself by sharp movements that sometimes resemble convulsions. It is known that these movements occur under the influence of ketamine in the blood stream. Difficulty in hearing and sensibility to light in some patients has also been reported.
THE GASTROINTESTINAL SYSTEM
Lose of appetite, nausea and vomiting has been observed, but normally this is not severe and allows most patients to take liquids orally soon after recovering consciousness.
GENERAL EFFECTS OF KETAMINE
Infrequent local pain and reddishness due to irritation in the area that was injected have been reported. Occasional rash has also been reported.
SPECIFIC SIDE EFFECTS OF midazolam include:
Midazolam may cause side effects such as respiratory problems and confusion. Most side effects disappear when the effects of using midazolam are over.
SPECIFIC SIDE EFFECTS OF clonidine include:
Even though side effects of clonidine are not common, they may occur. The following symptoms may be severe: decreased arterial pressure, dry mouth, sleepiness, vertigo, constipation, tiredness, headaches, nervousness, lessened sexual ability, irritated stomach, vomiting, rash, fainting, increase or decrease of heart beats, irregular heartbeat, swollen ankles or feet.
Problems WITH WEIGHT BEARING:
You must avoid bearing your weight as much as possible at least during two weeks after the ketamine emergency. CRPS may easily be reactivated by re-injury. You will be encouraged to follow the swimming pool exercises in a heated pool while you are in Monterrey. You are allowed and encouraged to bear weight lightly in the swimming pool because your body flotation is less likely to produce a re-injury to the lower extremities.
UPDATE FROM GERMANY:
The following is an update, dated March 8, 2006, concerning the results of thirty (30) subjects of the research given to Dr. Kirkpatrick by Dr. Robert Schwartzman, Professor and Chairman of Neurology of the University of Drexel, Philadelphia. Dr. Schwartzman is a co-researcher of the ketamine study that took place in Germany and is also a co-researcher in this study.
Nine of 30 patients have experienced a complete and permanent remission of CRPS symptoms that responded to previous treatments. One of these subjects had a complete remission during nine years and the others for more than five years.
Of the other 21 subjects, all of them had at least a partial remission; seven were completely free of pain during six to eight months after which the pain returned gradually.
Ten of the subjects are currently being treated with low sub-anesthetic doses of ketamine during four hours in an effort to reinforce the initial effect.
Pneumonia developed in eight of the 30 subjects, kidney infections in six, but they all responded to treatment.
Psychological tests were done in 15 of the 30 patients before and after the infusion of 5 days with ketamine and have shown no change of their mental function.
Dr. Schwartzman treated approximately 100 patients with the sub-anesthetic doses of ketamine. He found that this sub-anesthetic dose helps but does not cure patients. The anesthetic doses of ketamine seem to be necessary for a cure.
Dr. Schwartzman and his colleagues in Germany have not had any problem of addiction related to the use of ketamine by research subjects. He has stopped the reinforcement of low dose ketamine for any patient that did not have pain higher than 3 in a scale of pain from 0-10. Those patients that have been free of pain after the 5 day infusion have difficulty in accepting a pain count of 3/10. In that case, the German researchers stop the reinforcements of ketamine and try using non narcotic medicines against pain such as anti-inflammatory and neurontin.
As soon as we can, we will inform you if we find out anything else about the side effects of ketamine, midazolam and general anesthesia.
IT IS POSSIBLE WE MIGHT HAVE TO STOP YOUR TREATMENT.
If we determine that the treatment might harm you, we will stop the ketamine and midazolam infusion and we will awake you as fast as it is safe for you.
Any number of treatments might be needed in the follow-up period. For example, some subjects have required low doses of ketamine infusions in sessions that last approximately 2 to 4 hours each in order to maintain a remission of their CRPS when they return to the United States from Germany. Each infusion costs around $400 dollars. In a hospital setting, the charge for a 4-hour ketamine infusion might be much higher. Some, but not all insurance companies have been paying for the back-up infusions of low doses of ketamine. Some patients have reported having headaches and nausea during and after the low dose ketamine infusions. Phenergan and Zofran have been used to treat nausea and Fioricet for headaches.
Is there any risk to your unborn baby if you are part of this study?
If you are a woman
You must not be part of this study if you are pregnant or planning on being pregnant during the study period. If you are part of this study, it could happen that:
- Your unborn child might have problems now or in the future.
- A Breast-Fed baby could develop problems
- The morning before the study treatment, you will be asked to bring a urine sample to see if you are pregnant.
Immediately inform one of the study doctors if:
- You are pregnant.
- You have become pregnant.
- You are breast feeding.
If you participate in this study, you have to use a good birth control method such as (1) surgical sterilization, (2) accepted hormonal birth control (such as birth control pills, Depo-Provera, or Lupron Depot), (3) barrier methods (such as condoms or diaphragms) used with a spermicide, or (4) a IUD.
What other additional things must you know about the study?
1. Important companions in Mexico:
You will probably need at least two other important companions that know you well and who can be with you in Monterrey, Mexico, while you are hospitalized. Maybe two people could not be off work for so long. In that case, if it is only one person, they must be prepared to be by your side at least during 48 hours after the ketamine coma emergence.
2. The ketamine emergence:
Your companion must be at the ICU at all times while there are hallucinations/ paranoia during the ketamine emergence, if possible. The companion must give the patient verbal reassurance. However, there will be times in which the companion must leave the ICU temporarily for adequate attention of the patient.
3. Bearing weight:
You must avoid bearing your weight as much as possible at least during two weeks after the ketamine. CRPS may reactivate easily because of re-injury. You will be encouraged to follow a few exercises in a heated pool while you are in Monterrey. You are allowed to bear a little weight in the pool because it is less likely that you may re-injure the lower extremities while floating in the water. In case it is required, you will need to contract a “personal trainer" in Mexico so you can safely get in and out of the heated pool. As an alternative, Dr. Cantú located a place with a heated pool for handicapped people. This service could be added to your bill.
4. The low dose ketamine reinforcements:
You must avoid trauma/pain at least for 3 months after the ketamine coma. You will need to receive reinforcements of two hours of ketamine at low doses every 14 days during 3 months. At the end of the three months, the reinforcements of ketamine will be stopped to see how you feel without them. We do not know the best time for ketamine reinforcements. More patients need to be studied in order to make this determination.
Below you will find an internet address to obtain the protocol of the treatment used for a low dose ketamine infusion during 2 hours:
The ketamine reinforcement
5. Your assigned companion designated as the patient’s proxy:
The patient’s proxy must have a working cell phone for his/her use at all times when in Mexico.
6. Duration of your stay:
If there is any complication, such as a re-injury, your stay in Mexico could be longer than a week after being released from the hospital for observation and possible extension of treatment.
7. Prevention of CRPS:
The following medications are generally used to treat acute pain during the two weeks after you wake from the ketamine infusion. The drugs that will be used include:
- Acetaminophen 1000 mg=(Tylenol)
- High Doses of Celecoxib 400 mg (Celebrex)
- Gabapentin 300 mg (Neurontin)
It is important to note that the benefits take time, patience, and that recuperation might take months and progress may appear to be slow. Talking with other patients that have finished the coma study with ketamine may help lower expectations. To decrease expectations of a lasting and immediate relief of pain that is experienced at the beginning may help patients in their recuperation phase. The low dose strategies with outpatients as part of the study or solution, helps set more realistic goals...in the long run.
Needs for care of the patient and their family:
1. Transportation: We suggest a rented car with GPS for the family while you are in Monterrey. Taxis may be used instead of a rental car. However, it might be difficult to get a taxi after 8 pm at the hospital.
2. Special equipment: A video recorder is recommended to document the clinical progress. Access to internet is also recommended, but optional. Access to Internet is free in the business centers of many hotels in Monterrey. However, some hotels charge for accessing Internet. San Jose hospital has access in the private rooms to the Internet and in the cafeteria.
3. Hotel accommodations: You must consider the use of hotels located near the hospital and also a wheelchair while you are in Monterrey, Mexico.
4. Accommodations at home: The family has to arrange for hydrotherapy and infusions of low dose ketamine at home before returning from Mexico.
What happens if you are injured or become sick while you are part of the study?
If you need emergency attention:
Go to the closest hospital or emergency service immediately. Ask for help.
It is important you tell the doctors at the hospital or emergency service that you are part of a research study. If possible take with you a copy of this consent form with you when you go.
Call the study doctors as soon as you can. They need to know if you are injured or ill.
IF IT IS NOT AN EMERGENCY AND YOU BECOME ILL OR INJURED WHILE YOU ARE PART OF THIS STUDY:
Go to your regular doctor. It is important you tell the regular doctor that you are part of a research study. If possible, take a copy of this consent form with you when you go. San José Hospital might not be able to provide the kind of help you need. You might need to get this help in another place.
What will we do to maintain the privacy of your study files?
The medical staff that is taking care of you:
Maybe certain government and university personnel need to know more about the study. For example, individuals that tend to the monitoring of this study might need to see your files. This includes the ethics committee in Monterrey, Mexico, and the personnel that work for the IRB (Institutional Review Board). Other individuals who work for San Jose Hospital and who provide other type of monitoring might also need to see your files. This is done to make sure that we are doing our study in the correct manner. They also need to make sure that we are protecting your rights and safety. A MEMBER OF THE ETHICS COMMITTEE must be present during the reading and signing of the consent form and will also sign the document.
We may publish what we find out from this study. If we do, we will not let anyone know your name. We will not publish anything that would let any other person know who you are.
What happens if you decide not to participate in this study?
You must only be part of this study if you want to.
If you decide not to participate:
You will have no problems or lose any rights that you normally would have.
You will have the same level of health care.
You may continue receiving your regular treatments from your regular doctor.
What happens if you decide that you want to be part of this study and after that decide you want to drop out?
After signing this informed consent document you might decide not to be part of the study. If you decide that you do not want to be part of the study, advise the study staff as soon as possible.
We will tell you how to stop safely. We will let you know if there is any risk if you stop suddenly. You will need to assign a substitute to make decisions in your name when you are incapable of doing so. Your designated substitute may stop the study in your name during the 5 day ketamine infusion.
If you decide to stop, you may continue receiving attention from your regular doctor.
Are there any reasons for which we might decide to take you off the research after the study?
Even if you would like to remain part of the study, there might be reasons that make it necessary to remove you from the study. You could be removed from the study if:
We find out that it is not safe for you to remain in the study. For example, if your health could become worse. Or we find out the ketamine-midazolam general anesthesia could harm you. If so you could be removed from the study.
If you are not taking your medicine the right way or you are not going to your office appointments as scheduled.
If you develop an illness during the study treatment, such as an infection, that the study doctor considers might harm you.
You may obtain answers to your questions.
If you have any questions about this study, call Dr. Cantú or Dr. Kirkpatrick.
The signatures to be part of the Investigation and the consent:
It is up to you to decide if you want to participate in the study. If you want to participate, please read the following statements and sign the form if the statements are true.
I give my consent freely to be part of this study. I understand that I agree to be part of the research. I have received a copy of this consent form to keep with me.
Date and signature of the person who will be part of the study
Printed name of the person who will be part of the study
Signature and date of the proxy for health care
Printed name of the person who acts as proxy
(For example: family member or friend).
I have decided to take the following financial option that San Jose Technological Hospital of Monterrey has given me the absolute liberty to choose:
- Option 1.– A sole amount of $29,000.00 Dollars
- Option 2.– Patient pays the complete amount with established discounts
Signature of the person authorized to make the payment
Declaration of the person who obtains the informed consent
I have carefully explained to the person that is part of the study what he or she can expect.
I hereby certify that when this person signs the document, to my knowledge, he or she understands:
- What the study is about.
- What has to be done.
- The potential benefits.
- The known risks.
I also certify that he or she has no problem that might make it difficult for him or her to understand what it means to be part of the study. This person speaks the language used to explain this study.
This person reads enough to understand this document or, if not, this person can hear and understand when this form is read to him or her.
This person has no medical problems that could make it difficult to understand what is being explained and therefore, may give the informed consent.
This person is not taking any drugs that can make it difficult to understand what is being explained and therefore, may give the informed consent.
Signature of the person that obtains the informed consent and Date
Printed name of person who obtains the informed consent