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Informed Consent, Acknowledgement of Risks, Waiver of Claims, and Release of Liability for IV Ketamine Infusion Therapy
You are signing an Informed Consent, Acknowledgement of Risks, Waiver of Claims, and Release of Liability for IV Ketamine Infusion Therapy and agreeing to participate in IV Ketamine Infusion Therapy (IVKIT). It is important that you are aware of and acknowledge all risks and benefits of this therapy before you begin treatment. Please read the information carefully. If you have further questions, please ask your anesthesia provider for more information. We encourage you to research if IVKIT is the right choice for you.
Informed Consent
Ketamine is a dissociative class compound with an FDA schedule III designation. It is indicated for and commonly used as an anesthetic medication. It has a unique effect in that it can work very rapidly with individuals frequently seeing improvement in their depression within hours. However, ketamine response is not guaranteed and there may be relapse back into a depressive state. The FDA has labeled the use of ketamine for treatment of depression as “off label use” since this is not the original intended use.
MEDICAL CLEARANCE FOR TREATMENT
Prior to administration of ketamine, patients may be required to see a primary care provider to evaluate overall health. If you have significant cardiac, respiratory, hepatic or other complex condition your physician will have to clear you medically for IVKIT. Blood pressure medication should be optimized prior to ketamine administration. An EKG may be required in instances where there has been arrhythmia or a history of cardiovascular issues. Patients with a history of cystitis or other bladder issues may need to be cleared by a urological consultation, noting the rare but potential significant adverse effect of cystitis.
IN PREPARATION FOR IVKIT I CONSENT AND AGREE TO ABIDE BY THE FOLLOWING:
THE PROCEDURE
Before your first infusion, we will go over your health history and medication list. We will perform brief examination of your airway, heart, and lungs. Your blood pressure, pulse, respirations and oxygen saturation will be monitored. A small IV will be placed in your hand or arm using Lidocaine to numb the area. The infusion will begin after you are comfortable with your surroundings. The infusion will last around 40 minutes for depression, OCD, PTSD and anxiety. For chronic pain therapy the infusion times can last up to 4 hours.
You will be monitored throughout the procedure. Other medications may be given to mitigate nausea or other physical issues that may arise. We will be at your side to guide you through the process with as much support or as little support as you desire. After the infusion is complete, monitoring will continue until we feel you are safe and comfortable to be discharged. You will need to designate someone to drive you safely home.
MANAGEMENT OF ADVERSE EFFECTS
Our providers are trained in the management of cardiovascular events and airway access as defined by the ACLS treatment protocol. Intervention may include provision of anti-hypertensive medication, performing CPR, using an AED (defibrillator) and interventions to manage the airway; administration of tongue blade, bag-masking and oral airway devices. In the event of psychological distress, your provider may administer anxiolytic medication (ie. Midazolam). The treating provider reserves the right to activate emergency response systems, ie. call 911, if it is determined by clinical judgment that patient safety requires a higher level of care than can be provided in our office.
ONGOING AND CONCURRENT TREATMENT
The patient will be engaged in an ongoing and concurrent treatment with a psychiatrist and/or psychologist or primary care provider as deemed appropriate by Sun Valley Ketamine Clinic, LLC (SVKC). The termination or interruption of this collaborative treatment may result in termination of ketamine associated therapy.
Acknowledgment of Risks, Waiver of Claims, and Release of Liability
I am voluntarily participating in IVKIT at my own risk. I acknowledge the risks and complications associated with traveling from my infusion, driving, signing any legal documents or making any critical decisions as well as participating in IVKIT, which may include, but are not limited to physical or psychological injury, pain, suffering, illness, temporary or permanent disability, economic or emotional loss, and death. I assume all risk, both known or unknown to me, of my participation in IVKIT.
ADVERSE EFFECTS AND COMPLICATION OF IVKIT
Common side effects with low dose ketamine include but are not limited to:
Uncommon side effects from low dose ketamine include but are not limited to:
I acknowledge that I have carefully read this document and fully understand all terms herein. In consideration of the risk of injury while participating in IVKIT, and as consideration for the right to participate in IVKIT, I hereby, for myself, my heirs, executors, assigns, or personal representatives, knowingly and voluntarily enter into this Acknowledgment of Risks, Waiver of Claims, and Release of Liability and hereby waive any and all rights, claims or causes of action of any kind whatsoever arising out of my participation in IVKIT and hereby release and forever discharge SVKC, located at 630 Sun Valley Road, Ketchum, Idaho, 83340, their affiliates, managers, members, agents, attorneys, staff, heirs, representatives, predecessors, successors and assigns for any physical or psychological injury, including but not limited to illness, hospitalization, death, damages, economical or emotional loss, that I may suffer as a direct result of my participation in IVKIT, including traveling from IVKIT. If litigation arises pursuant to any claim made by me or anyone else acting on my behalf I agree to reimburse SVKC for any costs incurred, including attorney’s fees, medical fees and any related costs.
In the event that any damage is done to equipment or facilities as a result of my or my family’s willful actions, or recklessness, I acknowledge and agree to be held liable for any and all costs associated with any actions of recklessness.
To the extent that statute or case law does not prohibit releases for negligence, this release is also for negligence on the part of SVKC, and its agents and employees.
This agreement was entered into at arm’s-length, without duress or coercion, and is to be interpreted as an agreement between two parties of equal bargaining strength. Both_________________________________(Patient) and SVKC agree that this agreement is clear and unambiguous as to its terms, and that no other evidence will be used or admitted to alter or explain the terms of this agreement, but that it will be interpreted based on the language in accordance with the purposes for which it was entered into.
In the event that any provision contained within this document shall be deemed to be severable or invalid, or if any term, condition, phrase or portion of this agreement shall be determined to be unlawful or otherwise unenforceable, the remainder of this agreement shall remain in full force and effect, so long as the clause severed does not affect the intent of the parties. If a court should find that any provision of this agreement to be invalid or unenforceable, but that by limiting said provision it would become valid and enforceable, then said provisions shall be deemed to be written, construed and enforced as so limited.
FINAL DECLARATION
Patient name printed:______________________________________________
Patient Signature (or other legally responsible person)________________________________________date_____________
PROVIDER DECLARATION
I have discussed the infusion procedure, alternatives and risks with the patient. I have answered all of the patient’s questions and to the best of my knowledge, I believe the patient has been adequately informed and has consented to IVKIT.
Provider Signature_______________________________________________date_________________________
You are signing an Informed Consent, Acknowledgement of Risks, Waiver of Claims, and Release of Liability for IV Ketamine Infusion Therapy and agreeing to participate in IV Ketamine Infusion Therapy (IVKIT). It is important that you are aware of and acknowledge all risks and benefits of this therapy before you begin treatment. Please read the information carefully. If you have further questions, please ask your anesthesia provider for more information. We encourage you to research if IVKIT is the right choice for you.
Informed Consent
Ketamine is a dissociative class compound with an FDA schedule III designation. It is indicated for and commonly used as an anesthetic medication. It has a unique effect in that it can work very rapidly with individuals frequently seeing improvement in their depression within hours. However, ketamine response is not guaranteed and there may be relapse back into a depressive state. The FDA has labeled the use of ketamine for treatment of depression as “off label use” since this is not the original intended use.
MEDICAL CLEARANCE FOR TREATMENT
Prior to administration of ketamine, patients may be required to see a primary care provider to evaluate overall health. If you have significant cardiac, respiratory, hepatic or other complex condition your physician will have to clear you medically for IVKIT. Blood pressure medication should be optimized prior to ketamine administration. An EKG may be required in instances where there has been arrhythmia or a history of cardiovascular issues. Patients with a history of cystitis or other bladder issues may need to be cleared by a urological consultation, noting the rare but potential significant adverse effect of cystitis.
IN PREPARATION FOR IVKIT I CONSENT AND AGREE TO ABIDE BY THE FOLLOWING:
- I will not eat for at least 4 hours before my infusions. I may drink clear liquids for up to 2 hours before my infusions. I will take my usual morning medications with a sip of water EXCEPT for any benzodiazepine, Lamictal, sedating medications including narcotic pain medications.
- Following IVKIT I will not drive a car, operate hazardous equipment, or engage in hazardous activities. I will not participate in vigorous exercise.
- I will not conduct business or make important decisions for the remainder of the day after an infusion.
- I must tell the clinic about all medication I am taking.
- If I experience troublesome side effects after I leave the clinic, I will contact Shanna Angel at 206-817-0102. If I cannot reach her, I will call my primary care doctor, 911, or go to the local emergency room.
THE PROCEDURE
Before your first infusion, we will go over your health history and medication list. We will perform brief examination of your airway, heart, and lungs. Your blood pressure, pulse, respirations and oxygen saturation will be monitored. A small IV will be placed in your hand or arm using Lidocaine to numb the area. The infusion will begin after you are comfortable with your surroundings. The infusion will last around 40 minutes for depression, OCD, PTSD and anxiety. For chronic pain therapy the infusion times can last up to 4 hours.
You will be monitored throughout the procedure. Other medications may be given to mitigate nausea or other physical issues that may arise. We will be at your side to guide you through the process with as much support or as little support as you desire. After the infusion is complete, monitoring will continue until we feel you are safe and comfortable to be discharged. You will need to designate someone to drive you safely home.
MANAGEMENT OF ADVERSE EFFECTS
Our providers are trained in the management of cardiovascular events and airway access as defined by the ACLS treatment protocol. Intervention may include provision of anti-hypertensive medication, performing CPR, using an AED (defibrillator) and interventions to manage the airway; administration of tongue blade, bag-masking and oral airway devices. In the event of psychological distress, your provider may administer anxiolytic medication (ie. Midazolam). The treating provider reserves the right to activate emergency response systems, ie. call 911, if it is determined by clinical judgment that patient safety requires a higher level of care than can be provided in our office.
ONGOING AND CONCURRENT TREATMENT
The patient will be engaged in an ongoing and concurrent treatment with a psychiatrist and/or psychologist or primary care provider as deemed appropriate by Sun Valley Ketamine Clinic, LLC (SVKC). The termination or interruption of this collaborative treatment may result in termination of ketamine associated therapy.
Acknowledgment of Risks, Waiver of Claims, and Release of Liability
I am voluntarily participating in IVKIT at my own risk. I acknowledge the risks and complications associated with traveling from my infusion, driving, signing any legal documents or making any critical decisions as well as participating in IVKIT, which may include, but are not limited to physical or psychological injury, pain, suffering, illness, temporary or permanent disability, economic or emotional loss, and death. I assume all risk, both known or unknown to me, of my participation in IVKIT.
ADVERSE EFFECTS AND COMPLICATION OF IVKIT
- Ketamine increases sympathetic tone in the vasculature and can raise blood pressure, which has associated risks with adverse outcomes linked to stroke and arrhythmias, resulting in loss of function and possibly death.
- Ketamine has been associated with cystitis, a painful and potentially irreversible bladder condition. Cystitis has been generally reported in higher doses and more frequent uses, particularly in the substance abusing population.
- If you are pregnant or breastfeeding, you are not a candidate for IVKIT.
Common side effects with low dose ketamine include but are not limited to:
- Feeling of dissociation
- Floating feeling
- Numbness to face and hands
- Blurred vision
- Dizziness
- Increased heart rate and blood pressure
- Increased salivation
- Dry mouth
- Nausea and vomiting
- Impaired coordination and concentration
Uncommon side effects from low dose ketamine include but are not limited to:
- IV site redness or infection
- Allergic reaction to ketamine that may require emergency critical care
- Seizures
- Vivid dreams and hallucinations
I acknowledge that I have carefully read this document and fully understand all terms herein. In consideration of the risk of injury while participating in IVKIT, and as consideration for the right to participate in IVKIT, I hereby, for myself, my heirs, executors, assigns, or personal representatives, knowingly and voluntarily enter into this Acknowledgment of Risks, Waiver of Claims, and Release of Liability and hereby waive any and all rights, claims or causes of action of any kind whatsoever arising out of my participation in IVKIT and hereby release and forever discharge SVKC, located at 630 Sun Valley Road, Ketchum, Idaho, 83340, their affiliates, managers, members, agents, attorneys, staff, heirs, representatives, predecessors, successors and assigns for any physical or psychological injury, including but not limited to illness, hospitalization, death, damages, economical or emotional loss, that I may suffer as a direct result of my participation in IVKIT, including traveling from IVKIT. If litigation arises pursuant to any claim made by me or anyone else acting on my behalf I agree to reimburse SVKC for any costs incurred, including attorney’s fees, medical fees and any related costs.
In the event that any damage is done to equipment or facilities as a result of my or my family’s willful actions, or recklessness, I acknowledge and agree to be held liable for any and all costs associated with any actions of recklessness.
To the extent that statute or case law does not prohibit releases for negligence, this release is also for negligence on the part of SVKC, and its agents and employees.
This agreement was entered into at arm’s-length, without duress or coercion, and is to be interpreted as an agreement between two parties of equal bargaining strength. Both_________________________________(Patient) and SVKC agree that this agreement is clear and unambiguous as to its terms, and that no other evidence will be used or admitted to alter or explain the terms of this agreement, but that it will be interpreted based on the language in accordance with the purposes for which it was entered into.
In the event that any provision contained within this document shall be deemed to be severable or invalid, or if any term, condition, phrase or portion of this agreement shall be determined to be unlawful or otherwise unenforceable, the remainder of this agreement shall remain in full force and effect, so long as the clause severed does not affect the intent of the parties. If a court should find that any provision of this agreement to be invalid or unenforceable, but that by limiting said provision it would become valid and enforceable, then said provisions shall be deemed to be written, construed and enforced as so limited.
FINAL DECLARATION
- In signing this agreement, I acknowledge that I have an established a treatment relationship with SVKC. I understand that I have alternative treatment options for my condition. I understand that I may not respond or have a favorable response to IVKIT and there are risks associated with the treatment, some of which may be permanent.
- I know that I am receiving this treatment voluntarily.
- I understand that I may decide to withdraw from treatment at any time.
- I understand that my provider can stop the infusion without my consent.
- I am aware that most insurance companies do not cover IVKIT and I am responsible for all costs.
- I am aware that my insurance company will not be billed for this procedure.
- In the event that I should require medical care or treatment, I agree to be financially responsible for any costs incurred as a result of such treatment. I am aware and understand that I should carry my own health insurance.
- No guarantees or assurances have been made or given to me about the results that may be obtained.
- I agree to allow SVKC 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 IVKIT.
Patient name printed:______________________________________________
Patient Signature (or other legally responsible person)________________________________________date_____________
PROVIDER DECLARATION
I have discussed the infusion procedure, alternatives and risks with the patient. I have answered all of the patient’s questions and to the best of my knowledge, I believe the patient has been adequately informed and has consented to IVKIT.
Provider Signature_______________________________________________date_________________________
Please return to the top of this document to submit your Medical History Form.
