Helpful Tips for Maintaining the Safety of Ketamine Infusion Therapy

Ketamine infusion centers are spreading quickly throughout the United States. Many media channels have highlighted the groundbreaking moves to bring a novel treatment within reach of patients desperate for physical or psychiatric relief. But at the same time, some voice concerns about the industry being largely unregulated and lacking standardized clinical guidelines for many of ketamine’s potential uses.

Standards of care exist both for the patient and clinician’s protection. However, widely accepted clinical practice guidelines for ketamine administration currently do not exist for every potentially beneficial application. This is mainly due to the innovative nature of low-dose ketamine therapy for a variety of conditions. It is also due to the fact that we do not yet fully understand the wide range of clinical indications or protocols for which ketamine therapy may be useful. However, experts in pain management and psychiatry do have some general recommendations for maintaining the safety of ketamine infusion treatment. This article captures these proposals in brief.


What Should You Consider When Assessing a Patient’s Fitness for Ketamine Therapy?


We have already discussed some expert recommendations for screening ketamine patients in a previous article. To summarize, the provider will need to perform a thorough H&P on every prospective IV ketamine therapy recipient, and consultation of a psychiatrist or anesthesiologist may be advisable for more complex cases. These measures will help you assess the treatment’s potential benefits and risks for each potential patient.


IV ketamine infusion therapy is being utilized in outpatient clinics for the following applications:

  • Anesthesia for surgery or invasive diagnostic procedures

  • Providing relief of chronic pain conditions

  • Rapidly terminating suicidal ideations

  • Reducing relapse in those with alcohol abuse disorders

  • Reducing symptoms in those suffering from treatment-resistant depression, as well as other mental health conditions that are unresponsive to conventional treatment modalities.

You may check out our article on screening ketamine patients for more information on the patient selection process.


What Must Be the Ketamine Provider’s Qualifications?


The diagnostic and therapeutic abilities of ketamine providers differ widely. In the absence of published practice guidelines, psychiatric experts recommend that ketamine providers should at least have the following qualifications (Sanacora et al., 2017)

  • Can manage cardiovascular events, which may occur even at a low dose of the drug

  • Must be ACLS-certified

  • Can recognize mental status changes during ketamine infusion therapy and manage them accordingly

  • Can accurately assess suicide risk when providing ketamine for mental health

  • Can provide timely follow-up patient evaluations as needed

  • Has the necessary experience in administering ketamine IV infusion safely

  • Knows when and how to titrate the medication

For chronic and acute pain management, the dose can range from 0.2 to 6 mg/kg/hour (Cohen et al., 2018). Since these doses can lead to deeper levels of sedation, it is advisable that the clinician have sedation training and or the infusion should be directly supervised or performed by an anesthesia provider such as a physician or nurse anesthesiologist.


On the other hand, patients with intractable depressive symptoms are usually started on 0.5 mg/kg infused over 40 minutes. The need to adjust the dose upwards depends on many factors, including patient response, cardiorespiratory status, sedation depth, etc. The provider must be able to anticipate and act on the physiological and neuropsychiatric changes accordingly (Sanacora et al., 2017).


Additionally, ketamine is a DEA Schedule III controlled substance. Your clinic and providers should have providers licensed to prescribe the drug. (Sanacora et al., 2017). This typically includes a medical or advanced practice nursing license, a DEA license with Schedule III authority, and in some states requires and state-controlled substance license.


What Must You Have Inside a Ketamine Treatment Facility?


Clinicians should design their ketamine clinic for patient and healthcare personnel safety. Therefore, it must have the following (Sanacora et al., 2017; Ulrich et al., 2018; O’Donovan, 2007):

  • Clean waiting areas, treatment rooms, and toilets

  • Sterile IV equipment

  • Standard, non-invasive tools for tracking cardiac and respiratory function, including:

  • ECG

  • Blood pressure monitor

  • Pulse oximeter

  • End-tidal carbon dioxide level monitor

  • Equipment for managing an unstable patient, such as:

  • Oxygen support and a crash cart for acute cardiorespiratory episodes

  • Restraints for rare cases where an individual may show increasing agitation

  • A protocol for transferring patients to a larger treatment facility for severe cardiorespiratory problems

  • Features that help lessen patient stress, such as:

  • Ample space and uncrowded treatment room—to prevent flight or avoidant behavior

  • Peace and quiet—because noise can agitate patients

  • More eco-centered, less abstract artwork— sights of nature tend to calm patients down, while abstract themes may unsettle them

  • Ample daylight— it is associated with stress reduction

  • Good visibility—so the clinician can easily observe and monitor

  • No easy access to objects that can lead to self-harm

The Occupational Safety and Health Administration also requires private clinics to meet its workplace safety standards, which we shall explain in a future article. Getting your ketamine treatment facility ready for any eventuality enhances the patients’ safety and therapeutic experience.


Do You Have Protocols for Preparing to Start an Intravenous Ketamine Therapy Session?


Experts recommend that you must at least start with the following (Sanacora et al., 2017):

  • Take the patient’s baseline vital signs and mental status. But first, your clinic must have established acceptable pre-infusion parameters—a process that you may need to tailor for each patient.

  • Ensure the patient has transportation home.

  • Confirm the patient’s identity and dosing protocol.

  • Ask the patient to sign an informed consent form.

  • Have set conditions for stopping an infusion and a clear plan for managing any adverse event.

You will want to communicate your standard operating procedure to your staff, as this helps enhance patient care quality and efficiency (Buljac-Samardzic et al., 2020).


What Safety Practices Must You Have during an IV Ketamine Treatment Session?


At this point, you should have already checked off the following from your checklist (Sanacora et al., 2017; Sakurai et al., 2020):

  • A well-designed facility

  • Equipment for IV administration, monitoring patients and addressing emergencies

  • As-needed medications

  • Having a provider with the right qualifications for prescribing and administering ketamine infusion therapy. If you’re the provider, make sure that your licenses and certifications are up to date.

  • Establishing protocols for initiating ketamine treatment sessions and handling adverse events

During the infusion, the clinicians will be required to monitor the patient during the procedure. Keeping a close watch of the patient’s vital signs and mental status through the duration of the infusion and during post-infusion recovery.


What Should You Not Forget Before Discharging a Ketamine Patient?


Once the infusion process and recovery are complete, the next thing to do is initiate a discharge. But how does a clinician do that safely? Experts recommend the following:

  • Make sure that the patient has returned to a functional level that will permit a safe return to their current living arrangements. The vital signs must be normal or manageable at home. Cognition must be at or near the baseline. (Sanacora et al., 2017; Davis et al., 2021).

  • People who just had a ketamine procedure may still feel slightly groggy for a couple of hours. This is expected, so a responsible adult must accompany the patient home and be available to observe the patient (Short et al., 2018; Sanacora et al., 2017).

  • You may advise the patient to refrain from using heavy machinery, making important decisions, and using other sedating medications for the rest of the day (Sanacora et al., 2017).

  • Provide follow-up instructions and request that the patient contact 911 for any emergency or call the practice for other questions or concerns (Sanacora et al., 2017).

You may need to explain the discharge instructions both to the patient and their companion. Meanwhile, furnishing a written copy will help them remember the instructions. (Weetman et al., 2019).


How Should You Plan for Follow-up and Repeated Ketamine Infusions?


The duration and magnitude of ketamine’s effects differ from patient to patient owing to pharmacokinetic variability. That is why you should consider personalizing follow-up plans and subsequent doses (Sanacora et al., 2017; Cohen et al., 2018).


For example, the antidepressant effect of a single treatment may last up to seven days in some patients, but it may wane sooner in others (Abdallah et al., 2016). Meanwhile, repeated infusions have cumulative effects and can lead to longer-lasting remission (Phillips et al., 2019). Regular mental status checks in the post-treatment period can help the clinician determine the need for ketamine dose adjustments and individualize follow-up plans (Sanacora et al., 2017).


Lastly, psychiatrists and pain medicine experts have not published a hard criteria for deciding ketamine treatment futility. However, based on very limited information, it is often clear by the third infusion if continuing with the therapy will benefit the patient (Sanacora et al., 2017).


Knowing when to stop the treatment is important. For one, repeated ketamine infusions can be costly for the patient, since most insurance companies offer little to no coverage (Blum & Grey, 2021). For another, long-term use of this medication may create an increased risk for cystitis (Short et al., 2018). Note that significant cognitive impairment does not appear to manifest unless ketamine is administered at very high doses for extended periods of time and is usually only seen in ketamine abusers (Souza-Marques et al., 2021).


Like all other healthcare professionals, ketamine providers have an ethical responsibility to ensure that the benefits of their treatment plan outweigh the risks while understanding that not all risks can be eliminated entirely.


Reaping the Greatest Rewards by Being A Proponent of Ketamine Safety


There are currently no clinical practice guidelines published for all of ketamine’s off-label applications. So we turn to the next best thing—evidence-based expert recommendations and a review of the peer-reviewed literature, which we have cited in this article.


Ketamine infusion is effective for a variety of conditions. But good patient care also requires that we proceed cautiously when giving a Schedule III controlled substance. Always keep in mind that the patient comes first, being focused on safety not only ensures high-quality care but builds trust as well. In the long run, it also improves your ketamine clinic’s reputation.

 

References


Blum, B. & Grey, J. (2021). Administration of Ketamine for Depression Should Be Limited to Psychiatrists. Current Psychiatry, 20(9), e1-e2. https://doi.org/10.12788/cp.0175


Buljac-Samardzic, M., Doekhie, K. D. & van Wijngaarden, Jeroen D. H. (2020). Interventions to Improve Team Effectiveness within Health Care: A Systematic Review of the Past Decade. Human Resources for Health, 18(1), 1-42. https://doi.org/10.1186/s12960-019-0411-3


Cohen, S. P., Bhatia, A., Buvanendran, A., Schwenk, E. S., Wasan, A. D., Hurley, R. W., Viscusi, E. R., Narouze, S., Davis, F. N., Ritchie, E. C., Lubenow, T. R. & Hooten, W. M. (2018). Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Chronic Pain from the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine and the American Society of Anesthesiologists. Chronic and Interventional Pain, 43(5), 521- 546. https://doi.org/10.1097/aap.0000000000000808


Davis, M. T., DellaGiogia, N., Maruff, P., Pietrzak, R. H. & Esterlis, I. (2021). Acute Cognitive Effects of Single-Dose Intravenous Ketamine in Major Depressive and Posttraumatic Stress Disorder. Translational Psychiatry, 11(1), 1-10. https://doi.org/10.1038/s41398-021-01327-5


O’Donovan, A. (2007). Pragmatism Rules: The Intervention and Prevention Strategies Used by Psychiatric Nurses Working with Non-Suicidal Self-Harming Individuals. Journal of Psychiatric and Mental Health Nursing, 14, 64-71. https://doi.org/10.1111/j.1365-2850.2007.01044.x


Phillips, J. L., Norris, S., Talbot, J., Birmingham, M., Hatchard, T., Ortiz, A., Owoeye, O., Batten L. A. & Blier, P. (2019). Single, Repeated and Maintenance Ketamine Infusions for Treatment-Resistant Depression: A Randomized Controlled Trial. American Journal of Psychiatry, 175(5), 401-409. https://doi.org/10.1176/appi.ajp.2018.18070834


Sakurai, H., Jain, F., Foster, S., Pedrelli, P., Mischoulon, D., Fava, M. & Cusin, C. (2020). Long-Term Outcome in Outpatients with Depression Treated with Acute and Maintenance Intravenous Ketamine: A Retrospective Chart Review. Journal of Affective Disorders, 276, 660-666. https://doi.org/10.1016/j.jad.2020.07.089


Sanacora, G., Frye, M. A., McDonald, W., Mathew, S. J., Turner, M. S., Schatzberg, A. F., Summergard, P. & Nemeroff, C. B. (2017). A Consensus Statement on the Use of Ketamine in the Treatment of Mood Disorders. JAMA Psychiatry, 74(4), 399-405. https://doi.org/10.1001/jamapsychiatry.2017.0080


Short, B., Fong, J., Galvez, V., Shelker, W. & Loo, C. K. (2018). Side Effects Associated with Ketamine Use in Depression: A Systematic Review. The Lancet Psychiatry, 5(1), 65-78. https://doi.org/10.1016/s2215-0366(17)30272-9


Souza-Marques, B., Santos-Lima, C., Araujo-de-Freitas, L., Vieira, F., Jesus-Nunes, A. P., Quarantini, L. C. & Sampaio, A. (2021). Neurocognitive Effects of Ketamine and Esketamine for Treatment-Resistant Major Depressive Disorder: A Systematic Review. Harvard Review of Psychiatry, 29(5), 340-350. https://doi.org/10.1097/hrp.0000000000000312


Ulrich, R. S., Bogren, L., Gardiner, S. K. & Lundin, S. (2018). Psychiatric Ward Design Can Reduce Aggressive Behavior. Journal of Environmental Psychology, 57, 53-66. https://doi.org/10.1016/j.jenvp.2018.05.002


Weetman, K., Wong, G., Scott, E., MacKenzie, E., Schnurr, S. & Dale, J. (2019). Improving Best Practice for Patients Receiving Hospital Discharge Letters: A Realist Review. BMJ Open, 9(6), 1-13. https://doi.org/10.1136/bmjopen-2018-027588