Clinical TrialChronic PainKetamineKetaminePlaceboPlaceboRecruiting

The Effect of Outpatient Ketamine Infusion on Chronic Neuropathic Pain and PTSD

Prospective randomised pilot trial (n=30) comparing outpatient IV ketamine (0.5 mg/kg/hr) vs ketamine+magnesium vs magnesium control in military patients with chronic neuropathic pain; PTSD outcomes are secondary.

Target Enrollment
30 participants
Study Type
Phase IV interventional
Design
Randomized, double Blind

Detailed Description

Randomised, factorial, double-blind outpatient trial enrolling military-affiliated adults with chronic neuropathic pain to evaluate IV ketamine infusions (0.5 mg/kg/hr) alone or combined with magnesium, versus a magnesium control with delayed reassignment.

Infusions are administered in a diminishing schedule over 24 weeks (Weeks 1–2: 3/week; Weeks 3–4: 2/week; Weeks 5–6: 1/week; boosters at weeks 10 and 24). Outcomes include self-reported pain, PTSD questionnaires, anxiety, depression, quality of life, and medication use.

Study Protocol

Preparation

sessions

Dosing

14 sessions
240 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

IV ketamine infusions 0.5 mg/kg/hr over 4 h in a diminishing schedule across 24 weeks.

Interventions

  • Ketamine0.5 mg/kg/hr
    via IV• multiple over 24 weeks• 14 doses total

    Infused in 250 mL NS at 62.5 mL/hr over 4 h; dose calculated per IBW formula.

Ketamine + Mg

experimental

IV ketamine (0.5 mg/kg/hr) combined with magnesium sulfate (3 g per infusion) over 4 h.

Interventions

  • Ketamine0.5 mg/kg/hr
    via IV• multiple over 24 weeks• 14 doses total

    Ketamine infused in 250 mL NS at 62.5 mL/hr over 4 h; dose per IBW.

  • Placebo
    via IV• multiple over 24 weeks

    Magnesium sulfate 3 g (750 mg/hr) diluted into 250 mL NS and infused over 4 h (reported as active comparator; encoded as placebo reference with notes).

Magnesium control

active comparator

Magnesium sulfate 3 g infusion over 4 h; delayed control group reassigned after 2 weeks to an active treatment.

Interventions

  • Placebo
    via IV• multiple over 24 weeks

    Magnesium sulfate 3 g (750 mg/hr) in 250 mL NS over 4 h; delayed-control reassigned after 2 weeks.

Participants

Ages
18 – 70
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 18-70 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 Criteria

  • Exclusion Criteria:
  • 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

Study Details

Locations

Brooke Army Medical Center — San Antonio, Texas, United States

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