The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD
The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD: A Prospective Randomized Design
Margaux M. Salas, PhD
30 participants
Oct 2, 2024
INTERVENTIONAL
Conditions
Summary
This study is aimed to evaluate outpatient ketamine infusion within a military chronic neuropathic pain population and its effect on PTSD. Currently, this is a pilot study with 30 participants. Participants will be randomized to (1) a moderate dose ketamine, (2) moderate dose ketamine +Mg, or (3) a magnesium control group. Participants will complete self-reported pain and PTSD questionnaires throughout the \~24-week study period. The outlined strategy will provide evidence for the utility of ketamine in neuropathic pain management and pain associated comorbidities within a military population.
Eligibility
Inclusion Criteria6
- years old with Chronic Neuropathic Pain \>= 3 months
- Biologic male or biologic female
- Women of childbearing age will be included if there are no plans of pregnancy within the study period, the participant agrees to actively utilize contraception throughout the study, and agrees to pregnancy tests
- Active Duty, Veterans, and retirees
- Ketamine naïve for 1 year
- Moderate Neuropathic pain Scale 4-7
Exclusion Criteria22
- Cognitive dysfunction
- Psychiatric illness involving psychosis
- Neurocognitive disorder
- Patients with Traumatic Brain Injury (TBI)
- Acute cardiovascular disease or poorly controlled hypertension
- Untreated or uncontrolled thyroid disease
- Hyperthyroidism
- Severe liver or renal disease
- Renal impairment
- History of recent heart attack, vascular disease, or any other medical condition that may be deemed by a provider as a contraindication to receiving ketamine
- Active substance abuse
- Pregnant or lactating
- Patients who are planning to become pregnant within 12 weeks of treatment completion
- Elevated Blood Pressure/hypertension
- Known hypersensitivity to Ketamine
- Hemodynamic instability
- Respiratory depression
- Use of Theophylline or Aminophylline, Sympathomimetics and Vasopressin,
- Use of Benzodiazepines
- A history of drug abuse or dependence
- Active risk of substance use
- Patients who are not able to abide by the pre-treatment and posttreatment clinical protocol, such as food intake, abstaining from certain medications, unable to remain in the clinic for a minimum of 1 hour for observation, and cannot provide the name and phone number of the party who will pick them up post-treatment
Interventions
Ketamine will be placed in 250 mL normal saline and infused at a rate of 62.5 mL/hr. Participants will receive intravenous infusions of ketamine for 4 hours each day in diminishing number of dosing events per week for the full 24-week infusion regime in an outpatient setting. (ketamine 0.5 mg/kg IBW/hr)
Magnesium sulfate 3 grams will be diluted into 250 mL normal saline and infused at a rate of 62.5 mL/hr (over 4 hours until the entire contents are infused and then flushed with 20 mL of normal saline). The Mg only group will be randomly assigned to one of the treatment groups (moderate dose ketamine, or moderate dose ketamine +Mg) after 2 weeks and complete the full 24-week infusion treatment regime of the randomly selected treatment group in an outpatient setting.
Participants will receive intravenous infusions of ketamine and magnesium sulfate in combination. Ketamine will be placed in 250 mL normal saline and infused at a rate of 62.5 mL/hr Participants will receive intravenous infusions of ketamine and magnesium sulfate for 4 hours each day in diminishing number of dosing events per week for the full 24-week infusion regime in an outpatient setting. (Ketamine 0.5 mg/kg IBW/hr + magnesium sulfate 3 grams diluted into 250 mL normal saline)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06414356