INFORMED CONSENT FOR SPRAVATO THERAPY
Before you decide to take part in this procedure, it is important for you to know why it is being done and what it will involve. This includes any potential risks to you, as well as any potential benefits you might receive. Read the information below closely and discuss it with family and friends as you wish. Ask TMHCare if there is anything that is not clear, or if you would like more details. Take your time to decide. If you do decide to take part, your signature on this consent form will show that you received all of the information below, and that you were able to discuss any questions and concerns you had with TMHCare.
Ketamine is approved by the FDA for anesthesia, and for sedation during medical procedures. Since its approval in 1970, it has been widely used in operating rooms and emergency departments. Ketamine’s use for the treatment of depression, anxiety, chronic pain, OCD, or drug or alcohol abuse is off-label and has not been approved by the FDA.
1. RISKS and SIDE EFFECTS of Spravato:
Common side effects, greater than 1% and less than 10%:
vivid dreams and nightmares
nausea and vomiting
increased saliva production
increased heart rate and blood pressure during the infusion
out of body experience during the infusion
change in motor skills.
These symptoms dissipate when the infusion is stopped. If they are severe, another medication such as a sedative can be used to treat the symptoms. You should not drive the day of an infusion and can resume driving the following day.
Uncommon side effects, greater than 0.1% and less than 1%:
pain and redness in the injection site
Increased pressure in the eye
jerky arm movements resembling a seizure.
Rare side effects, greater than 0.01% and less than 0.1%:
irregular or slow heart rate
low blood pressure
cystitis of the bladder: inflammation, ulcers, and fibrosis
Even more severe side effects up to and including death are possible, but extremely unlikely, such as a fatal allergic reaction to one of the medications.
Spravato can cause various symptoms including but not limited to flashbacks, hallucinations, feelings of unhappiness, restlessness, anxiety, insomnia and disorientation.
Risk of other medications interacting with Spravato. It is very important that you disclose all medications (both prescription and over the counter) and supplements that you are taking.
Spravato may not help your depression, bipolar disorder, PTSD, anxiety, other mental health conditions, or chronic pain syndrome.
Unlike conventional antidepressants, Spravato has been associated with a rapid decrease in depression symptoms. While the goal is improvement of symptoms, results cannot be guaranteed, and there is no way to predict how any individual will respond to Spravato. These effects may not be long lasting and will most likely require further infusions. Spravato is not the only option for patients with treatment-resistant depression. There are other alternatives, including electroconvulsive shock therapy (ECT) and transcranial magnetic stimulation (TMS).
4. WHAT SAFETY PRECAUTIONS MUST I TAKE?
I will not eat or drink for at least six hours before each of the infusions. I may, however, drink clear liquids for up to two hours before an infusion. I will take all of my usual morning medications with a few sips of water before an infusion, EXCEPT for Lamictal, any benzodiazepines, and any sedating drugs including narcotic pain medication.
I will NOT drive a car, operate hazardous equipment, or engage in hazardous activities for 24 hours after each treatment as reflexes may be slow or impaired. Another adult will need to drive me home.
I will not conduct business or make any important decisions the remainder of the day after an infusion.
I must refrain from alcohol or other substances prior to, and for 24 hours after a treatment.
I must tell the clinic about all medications I am taking, especially narcotic pain relievers or barbiturates.
If I experience a troublesome side effect after I leave the clinic, I should contact the medical staff of TMHCare at 208-225-8642. If I cannot reach him directly, I should call my primary care doctor, call 911, or go to my local emergency room.
5. IMPORTANT CAVEATS:
Spravato THERAPY IS NOT A COMPREHENSIVE TREATMENT FOR DEPRESSION, ANXIETY OR ANY PSYCHIATRIC SYMPTOMS; NOR FOR CHRONIC PAIN, NOR FOR DRUG AND ALCOHOL ABUSE. Your Spravato treatments are meant to augment (add on to, not be used in place of) a comprehensive treatment plan. We advise you to be (and I agree to be) under the care of a qualified mental health professional (or an internal medicine or family physician with experience and skill in treating psychiatric illnesses) while receiving Spravato, and for the duration of your psychiatric symptoms. Pain patients should be under the care of a pain management physician as well as a primary care provider – we provide ketamine infusions only, and do not diagnose or provide comprehensive pain management treatment INCLUDING the prescription of pain medications. Follow up medications may be suggested but these will be the responsibility of your treating physician.
SPECIAL NOTE ON SUICIDAL IDEATION
Psychiatric illnesses (especially, depression), chronic pain, and addictions carry the risk of suicidal ideation (thoughts of ending one’s life). Any such thoughts you may have now, at any time during the weeks of your ketamine infusions, or at any point in the future, which cannot immediately be addressed by visiting with a mental health professional you should seek emergency care at an ER or call 911.
Spravato USE DURING PREGNANCY OR BREAST FEEDING IS NOT GENERALLY RECOMMENDED
6. VOLUNTARY NATURE OF THE TREATMENT
You are free to choose to receive or not receive the ketamine infusion. Please tell the doctor if you do not wish to receive treatment.
7. WITHDRAWAL OF TREATMENT
Your doctor has the right to stop treatment with or without your consent for any reason.
8. PATIENT CONSENT
I agree to be under the care of a qualified mental health professional (or an internal medicine or family physician with experience and skill in treating psychiatric illnesses) while receiving ketamine infusions, and for the duration of your psychiatric symptom. I agree to allow TMHCare to access all information pertaining to my mental healthcare and permission to speak to my mental healthcare provider to discuss my condition and the administration of Spravato. The possible alternative methods of treatment, the risks involved, and the possibility of complications have been fully explained to me. No guarantees or assurances have been made or given to me about the results that may be obtained.
Please do not sign this Consent until you have spoken with the medical staff of TMHCare about the procedure and had all of your questions answered including those about risks and alternatives.