Informed Consent for Ketamine Infusion Therapy
Ketamine is approved by the FDA for use in children and adults for anesthesia and as a pain reliever during medical procedures. When administered in a low-dose infusion, ketamine is a medication that may provide relief of symptoms of depression, anxiety, post-traumatic stress disorder (PTSD), and acute and chronic pain. Ketamine's use for the treatment of pain, depression, or other mental illnesses is off-label. Off-label use of medications is legal and very common. In fact, about one in five prescriptions written in the US today is off-label.
Why Is Ketamine Being Recommended?
Numerous studies show that ketamine may be helpful in the treatment of depression, anxiety, PTSD, acute and pain. When administered by vein over a period of 40 minutes up to 4 hours (called an infusion), ketamine may help improve symptoms rather quickly. Improvements may last several days up to a few months. A series of infusions is recommended so that symptom relief has a longer duration of action. While the goal is an improvement of symptom individual results cannot be guaranteed.
What Will Be Done?
You will be receiving ketamine by IV Infusion. This means an IV catheter will be inserted into a vein of your hand or arm and a ketamine fluid will be dripped into the vein. During the infusion, your level of sedation, blood pressure, heart rate, oxygen concentration, heart rhythm, and respiration will be monitored. After the treatment, you will need time to recover in the office and may take some sips of fluid during the recovery period. For depression, current research recommends that you receive 6 treatments over about two weeks as the primary treatment episode. Additional maintenance treatments may or may not be suggested, occurring about once a month or less frequently as recommended by your infusion provider. For pain, the frequency of Ketamine infusions is based on your specific type of pain and response to therapy.
What Safety Precautions Must You Take?
- You may not eat or drink 8 hours before the infusion, water is the only exception. You may drink water up to 2 hours before the infusions.
- You may NOT drive a car, operate hazardous equipment, or engage in hazardous activities for at least 24 hours after each treatment as reflexes may be slow or impaired. Another adult will need to drive you home and must be present prior to your discharge.
- You must refrain from a alcohol 24 hours prior to and following ketamine administration. You must refrain from other illegal substances during your ketamine infusion treatment.
- You must tell the clinic about all medications you are taking, especially narcotic pain relievers,
benzodiazepines, barbiturates and muscle relaxers.
- To qualify to receive ketamine therapy for mental health conditions, you must notify and share the contact information for the mental health provider treating your psychiatric symptoms or your curent primary care provider.
- If you experience a minor side effect while you are at home, you should contact the Infusion Clinic (800-679-4951), otherwise contact your medical provider or call 911.
What Are the Possible Side Effects of Ketamine?
Possible side effects may include and are not limited to:
- fast or irregular heart beats
- increased or decreased blood pressure
- vivid dreams
- irritation or excitement
- floating sensation ("out-of-body")
- twitching, muscle jerks, and muscle tension
- urinary frequency
- increased saliva or thirst
- lack of appetite
- metallic taste
- blurry or double vision
- nausea or vomiting
- memory changes
Rare side effects of ketamine are:
- allergic reactions
- pain at site of injection
- increase in pressure inside the eye
- inflammation in the bladder
- respiratory complications
- involuntary eye movements
- low mood or suicidal thoughts
Side effects of receiving of IV are:
- mild discomfort at the site of placement
Important Notices and Agreements:
- KETAMINE INFUSION THERAPY IS NOT A COMPREHENSIVE TREATMENT FOR DEPRESSION, ANXIETY OR ANY PSYCHIATRIC SYMPTOMS Your ketamine infusions are meant to augment(add on to, not be used in place (comprehensive psychiatric treatment. Therapy is a recommended adjunct.
- While receiving ketamine infusions, you agree to remain under the care of a qualified primary care or mental health provider and have your overall health care directed by him or her
- Psychiatric illnesses carry the risk of suicidal ideation (thoughts of ending one's life) or thoughts of harming others. Any such thoughts you may have at any time during your ketamine infusion therapy, or at any point in the future, which cannot immediately be addressed by visiting with a mental health professional should prompt you to seek emergency care at an ER or to call 911.
- (Women only) Ketamine use during pregnancy is not generally recommended. Females will be asked to submit a urine sample for a pregnancy test prior to your first infusion and every 2 weeks thereafter.
My Consent for Ketamine Treatment is Voluntary:
My request for ketamine infusion treatments as described is entirely voluntary and I have not been offered any inducement to consent. I understand that I may refuse ketamine treatments at any time. Any money I have deposited for future treatments will be refunded to me if I choose not to proceed with future infusions. I have been advised that I can seek a second opinion from another provider before agreeing to have ketamine treatment and I am choosing to proceed at this time, with or without this second opinion. I have notified my mental health provider and/or primary care provider of my ketamine infusion therapy.
Statement of Person Giving Informed Consent
- I have read this consent form and understand the information contained in it. I understandthe risks and benefits and have had the opportunity to have all my questions answered tomy satisfaction.
- I have had the opportunity to ask questions about this procedure. I consent and would like to proceed with ketamine infusion treatment.