Informed Consent for Ketamine Treatment
SCOPE: This consent form contains information about the use of subanesthetic ketamine therapy for the treatment of depression and other psychiatric illnesses.
Introduction
Ketamine is approved by the FDA for anesthesia and sedation during medical procedures. Since its approval in 1970, Ketamine has been commonly used in operating rooms and emergency departments. The use of Ketamine in lower, subanesthetic doses to treat depression is a newer, “off-label” use of Ketamine. It is usually used after other treatments have been unsuccessful. While Ketamine is not formally approved by the FDA for this use, there are now many studies that demonstrate it may be an effective and rapid treatment option for multiple disorders including major depressive disorder, bipolar disorder, and substance use disorder.
Procedure
Ketamine can be given as an intravenous (IV) injection or drip, intramuscular (IM) injection, or nasal spray. You will remain awake and able to talk during the procedure, but your perception and mental state will likely be altered by the Ketamine. You will return to a normal mental state as the immediate medication effects wear off.
You may ask your provider any questions you may have concerning the procedure or effects of Ketamine at any time. Your consent to receive Ketamine may be withdrawn by you and you may discontinue your participation at any time up until the actual dose has been administered.
Contraindications to Ketamine Therapy
Ketamine therapy should not be used in patients with the following: • Pregnancy or breastfeeding mother • Uncontrolled high blood pressure • Untreated hyperthyroidism • Prior hypersensitivity or negative reaction to ketamine Possible Side Effects The side effects of Ketamine may depend on the dose and frequency of treatments, and may include: • Blurred vision, uncomfortable vision, double vision, rapid eye movements, elevation of intra-ocular pressure (feeling of pressure in the eyes). • Slurred speech • Anorexia • Mental confusion, excitability, anxiety • Diminished ability to see, hear or feel objects accurately including one’s own body • Nausea, vomiting, and aspiration • Elevation of pulse or blood pressure • Impaired balance and coordination • Sleepiness • Headaches • Ketamine may worsen certain psychotic symptoms in people who suffer from schizophrenia or other serious mental disorders including severe personality disorders. • Ketamine can bring up traumatic memories, may cause you to re-experience past traumas or force you to look at parts of yourself that may be uncomfortable. Potential for Ketamine Abuse and Physical Dependence Ketamine belongs to the same group of chemicals as phencyclidine (PCP or angel dust). This group of chemical compounds is known Arylcyclohexylamines and are classified as hallucinogens. Ketamine is a controlled substance and is subject to Schedule III rules under the Controlled Substance Act of 1970. Medical evidence regarding the issue of drug abuse and dependence suggests that Ketamine’s abuse potential is equivalent to that of phencyclidine and other hallucinogenic substances. Ketamine and other hallucinogenic compounds do not meet criteria for chemical dependence since they do not cause tolerance and withdrawal symptoms. However, “cravings” have been reported by individuals with the history of heavy use. In addition, Ketamine can have effects on mood (feelings), cognition (thinking) and perception (imagery) that may make some people want to use it repeatedly. Therefore, Ketamine should never be used except under the direct supervision of a licensed physician. Safety Precautions You agree to abide by the following safety precautions while undergoing Ketamine therapy: • Do not eat or drink for at least six hours before a treatment session. • Report all prescription and non-prescription drugs that I am taking to my physician and discuss whether they should be continued or discontinued during Ketamine treatment (especially any narcotic pain relievers, benzodiazepines, sleeping pills, barbiturates, and muscle relaxers). • Do not drive a car, operate hazardous equipment, engage in hazardous activities or make any important decision for the remainder of the day following Ketamine treatment. • Refrain from use of alcohol or other sedating substances for 6 hours prior to, and for 6 hours after Ketamine treatment. Monitoring It is essential that you be monitored closely during and after Ketamine treatments. You acknowledge and agree that a sitter must be present during your Ketamine treatments and you will not take the medication without your sitter being present. Post-treatment you will complete an experience questionnaire as close to the end of your treatment as possible, and your sitter may be helpful in completing this questionnaire.
Consent
By signing this form, you agree to the following:
1. You agree to follow any direct instructions given to you by the EDIT staff to prepare you for Ketamine treatment.
2. You agree to have a sitter present during the treatment and to not administer the medication alone.
3. You agree to remain at the location of the session until your sitter presses “stop” on the experience tracker and decides you are ready to move around again.
4. You have fully read this informed consent form describing Ketamine therapy and agree to its terms.
5. You have had the opportunity to ask questions and have received satisfactory answers concerning Ketamine therapy.
6. You understand the risks and benefits of Ketamine therapy.
7. You understand that you may withdraw from Ketamine therapy at any time. 8. You voluntarily consent to participate in Ketamine assisted therapy as outlined in this form and under the conditions indicated in it.