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Informed Consent

what to expect after ketamine infusion therapy

Informed Consent For Ketamine Therapy

Reviewed on 6/5/2025

​​​Before you decide to take part in this procedure, you need 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 our staff 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 North Idaho Ketamine and TMS.  

 

Ketamine is approved by the FDA for anesthesia, and 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. PROCEDURE – KETAMINE INFUSION THERAPY 

 

A peripheral intravenous line (IV) will be started. Your vital signs will be monitored throughout the infusion. You will be given a subanesthetic dose of ketamine, by slow continuous infusion. The duration of the infusion varies from 60 to 120 minutes. Depending upon your response to this first infusion, we may increase the dose incrementally with your subsequent infusions to maximize your response. We will also often adjust the infusion rate during each infusion, depending on how you are responding, to maximize the effectiveness of each infusion. Adjuvant medications may also be administered if necessary, such as anti-nausea medication, mild sedatives for agitation, etc. 

 

2. RISKS and SIDE EFFECTS of ketamine: 

 

Side effects normally depend on the dose and how quickly the injection is given. The dose being used for this purpose is generally lower than anesthetic doses and will be given by slow continuous infusion. Side effects often go away on their own. The incidence of side effects is higher with more prolonged infusions. 

 

Common side effects, greater than 1%, and less than 10%: 

  • hallucinations 

  • vivid dreams and nightmares  

  • nausea and vomiting  

  • increased saliva production 

  • dizziness 

  • blurred vision  

  • 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 on the day of an infusion and can resume driving the following day. 

 

Uncommon side effects, greater than 0.1%, and less than 1%: 

  • rash 

  • double vision 

  • 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%: 

  • allergic reaction 

  • irregular or slow heart rate 

  • arrhythmia 

  • 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. 

 

Other Risks: 

  • Ketamine can cause various symptoms including but not limited to flashbacks, hallucinations, feelings of unhappiness, restlessness, anxiety, insomnia, and disorientation. 

  • The uncommon risk of a dosing error, or unknown drug interaction that may require medical intervention including intubation (putting in a breathing tube), or hospitalization. 

  • Starting an IV may cause temporary discomfort from the needle stick, bruising, or infection. Fainting may also occur. 

  • Risk of other medications interacting with ketamine. You must disclose all medications (both prescription and over-the-counter) and supplements that you are taking. 

  • Ketamine may not help your depression, bipolar disorder, PTSD, anxiety, other mental health conditions, or chronic pain syndrome. 

 

3. BENEFITS 

 

Unlike conventional antidepressants, ketamine has been associated with a rapid decrease in depression, bipolar, and PTSD symptoms. It has also been shown to be helpful with a variety of chronic pain syndromes, and with alleviating the cravings for drugs and alcohol. The initial series of infusions is used to prolong the longevity of improvement. While the goal is the improvement of symptoms, results cannot be guaranteed, and there is no way to predict how any individual will respond to ketamine infusion therapy. These effects may not be long-lasting and will most likely require further infusions. Ketamine 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). Ketamine is not the only option for patients with chronic pain. Other alternatives include pain medicines, anticonvulsants, physical therapy, cognitive-behavioral therapy, steroid injections, spinal pumps, spinal cord stimulation, and surgery. Ketamine is also not the only option for alcohol and drug abuse. 

 

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 for the remainder of the day after an infusion. 

  • I must refrain from alcohol or other substances before, and for 24 hours after an infusion. 

  • 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 North Idaho Ketamine & TMS at 208-215-7936. 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:

 

KETAMINE INFUSION THERAPY IS NOT A COMPREHENSIVE TREATMENT FOR DEPRESSION, ANXIETY, OR ANY PSYCHIATRIC SYMPTOMS; NOR FOR CHRONIC PAIN, NOR DRUG AND ALCOHOL ABUSE. Your ketamine infusions 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 ketamine infusions 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. 

 

KETAMINE USE DURING PREGNANCY OR BREASTFEEDING 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 the infusion. 

 

7. WITHDRAWAL OF TREATMENT 

 

Your doctor has the right to stop the infusion at any time. They can stop the infusion with or without your consent for any reason. 

 

8. Potential Risks of Combining GLP-1 Medications with Ketamine Infusions

 

The combination of GLP-1 medications with ketamine infusions may pose certain risks, some of which are outlined below:

 

 A. Risk of Pulmonary Aspiration

 

Pulmonary aspiration occurs when food, liquid, or other foreign substances enter the airway or lungs, which can lead to serious complications such as aspiration pneumonia. One of the effects of GLP-1 medications is that they slow gastric emptying, meaning that food and liquids remain in the stomach for a longer period than they would normally. This delayed gastric emptying can increase the risk of regurgitation (the backward flow of stomach contents) and aspiration during procedures such as ketamine infusions, especially when sedation or anesthesia is involved.

 

During ketamine infusions, there is a risk of compromised airway reflexes and reduced muscle tone, which may increase the likelihood of aspiration if the stomach contains food or liquid. Therefore, it is particularly important that you fast for the recommended period before receiving a ketamine infusion if you are taking GLP-1 medications.

 

 B. Other Gastrointestinal Effects

 

In addition to delayed gastric emptying, GLP-1 medications can cause other gastrointestinal side effects such as nausea, vomiting, and bloating. These side effects may be worsened by ketamine, especially when administered at higher doses or in patients with sensitive gastrointestinal systems. In some cases, the combination of these medications may lead to more pronounced discomfort or vomiting, which could further elevate the risk of aspiration.

 

Recommendations for Reducing the Risk of Pulmonary Aspiration

 

To reduce the risk of pulmonary aspiration and other adverse effects, the following measures will be taken:

 

1. Fasting Requirements: You will be instructed to fast from food for a minimum of 6 hours and fast from all liquids for a minimum of 2 hours before your ketamine infusion if you are taking GLP-1 medications. This is essential to reduce the amount of food or liquid in the stomach and lower the likelihood of regurgitation and aspiration during the procedure.

 

2. Monitoring During Infusion: You will be closely monitored throughout the infusion process to ensure that any signs of distress or complications are detected promptly. This will include monitoring your respiratory status, oxygen levels, and overall comfort.

 

3. Adjusting Dosage: In some cases, your healthcare provider may adjust the dose of either the GLP-1 medication or the ketamine infusion to minimize any potential interactions or side effects.

 

4. Medication Timing: We may also discuss altering the timing of your GLP-1 medication relative to the ketamine infusion to allow for maximum effectiveness and minimal gastrointestinal distress.

 

9. 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 my psychiatric symptoms. I agree to allow North Idaho Ketamine & TMS to access all information about my mental healthcare and permission to speak to my mental healthcare provider to discuss my condition and the administration of Ketamine Infusion therapy. I know that ketamine is not an FDA-approved treatment for depression, bipolar disorder, or PTSD. I know that taking part in this procedure is my choice. I know that I may decide not to take part or to withdraw from the procedure at any time. I know that I can do this without penalty or loss of treatment to which I am entitled. I also know that the doctor may stop the infusion without my consent. I also know that ketamine infusion therapy may not help my depression, bipolar disorder, or PTSD. I have had a chance to ask the doctor questions about this treatment, and those questions have been answered to my satisfaction. 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. 

 

I understand that NIKT does not provide primary care and is not a source for referrals, or any forensic evaluations including fitness for duty or disability claims. All referrals, paperwork, forms, etc will be directed to your primary physician.

 

Please do not sign this Consent until you have spoken with the medical staff of TMHCare/NIKT about the procedure and had all of your questions answered including those about risks and alternatives. 

 

You can communicate with us in the following ways:

 

In the office or by phone/text message: 208-215-7936

By email: help@tmhcare.com

Cancellation Policy: 

Our policy is to charge $50 to the credit card on file for appointments canceled with less than 24 hours notice. If no notice is given and the session is not attended, our policy is to charge $100 to the credit card on file. These charges will be your responsibility and billed directly to you. Please help us to better serve you by providing us with notice of cancellation. 

Magstim Transcranial Magnetic Stimulation

Informed Consent For TSM

Reviewed on 6/5/2025

Transcranial Magnetic Stimulation (TMS) is prescribed by psychiatrists and administered by trained TMS technicians who are familiar with different TMS protocols. The TMS technician is directly supervised by the psychiatrist and may only administer exactly what is prescribed. Technicians may not be clinicians and can not make treatment  recommendations; however they are trained to handle an emergency if one arises. Physician supervision takes place in many ways.  

  • Through an initial diagnosis, treatment planning with a decision to utilize a specific TMS  protocol.
     

  • Treatment progress is monitored through patient rating scales and follow-up appointments every two weeks. Rating scales may be annoying, but they are required for data collection and insurance coverage determinations.
     

  • If necessary, the TMS technician can call the physician to answer a question and have the  physician observe the treatment in person.
     

  • If there is some uncertainty about whether to continue TMS or change the protocol, this should  be discussed with the physician in an appointment and not with the technician.  

Risks and Discomforts  

TMS has been used worldwide since 1985 and FDA approved since 2008; however there are a  series of adverse effects that can occur from TMS.

 

I understand the following adverse effects are possible: 

 

_____ Up to 10% of patients undergoing TMS experience headaches, face pain, jaw pain, tooth pain or neck pain. You can take ibuprofen, acetaminophen, or aspirin, which in most cases relieves the pain. Almost all patients find TMS to be tolerable.
 

_____ TMS produces a loud clicking noise during stimulation, which can result in tinnitus or hearing loss especially if ear protection is not used. To prevent risk of hearing disturbances, earplugs will be given to wear. The risk for hearing loss with hearing protection is not known but is most likely less than 0.01% or 1 in 10,000 patients.
 

_____ TMS can induce a convulsion even in the absence of brain lesions, epilepsy, or other risk  factors for seizures. The overall risk for seizures during TMS is not known but it is less frequent  than 0.5% or 5 in 1,000 patients. TMS does not cause epilepsy. In patients with known epilepsy, the risk is 1%.
 

_____ TMS could potentially cause unintended teeth clenching, biting of the tongue and chipping  teeth. The overall risk for this is not known.
 

_____ TMS could theoretically induce transient changes in cognition or movement, although safety studies have not found such side effects to date.
 

_____ I am aware there may be some unexpected complications.
 

_____ I am aware that the risks of exposure to a magnetic field during pregnancy are not fully  understood.

 

To date there is only one absolute contraindication for repetitive TMS, the presence of a  ferromagnetic substance in the head. Ferromagnetic means a substance that is highly  susceptible to magnetization. We do not know about long-term consequences of TMS, since it  was only FDA approved for depression in 2008. It is strongly advised not to interrupt your  treatment during the acute phase. Please review the following summary of expenses. 

INITIAL EVALUATION, ELIGIBILITY CONSULTATION: This is typically a 1-hour consultation with the doctor to determine your eligibility for treatment, as well as determine the appropriate protocol. This does not include locating the treatment area  with the device.  

FOLLOW UP COSTS: While in the acute TMS treatment phase, you are required to attend  follow up visits with the doctor every two weeks. These will be billed to your insurance company as a regular office visit.

 

MISSED APPOINTMENTS: We ask that you call 24 hours in advance from your scheduled  appointment to reschedule your missed appointment.

INSURANCE: At the present time, insurance covers TMS only in some cases of treatment  resistant depression. Before you start treatment we will contact your insurance company to  obtain prior authorization if needed. However, that is not a guarantee of benefits. If your  insurance is canceled during treatment you will be responsible for the cost of treatment. Our  office will do our best to get the most accurate cost of treatments but ultimately it is your  insurance company so we advise you to contact them as well.  

I understand that in the event of injury, Tranquil Mind Health Care will not compensate me. Reasonable medical treatment will be offered for injuries directly caused by my TMS treatment, for which my insurer or I will be billed at the usual fee. I release Tranquil Mind Health Care and all of the providers and technicians from any and all liabilities and expenses related to my decision to receive TMS as part of my care.  

I understand that I have the option to obtain treatment elsewhere and will be provided a referral  letter if required.

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