Clinical TrialChronic PainKetaminePlaceboKetaminePlaceboTerminated

The Effects of Ketamine and Methadone on Postoperative Pain for Laminectomy

This Phase IV interventional trial (n=13; terminated) aimed to assess the pain-reducing effects of ketamine and methadone after lumbar laminectomy.

Target Enrollment
13 participants
Study Type
Phase IV interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomized, quadruple‑masked, parallel Phase IV trial comparing IV ketamine, IV methadone, and their combination for intraoperative use to reduce postoperative pain after lumbar laminectomy.

Primary aim was to evaluate whether intraoperative ketamine (0.5 mg/kg bolus plus 5 µg/kg/min infusion), methadone (0.2 mg/kg preinduction), or their combination reduces postoperative opioid requirements and improves recovery outcomes.

Study Protocol

Preparation

sessions

Dosing

1 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

active comparator

IV ketamine bolus during induction (0.5 mg/kg) with intraoperative IV ketamine infusion (5 µg/kg/min).

Interventions

  • Ketamine0.5 mg/kg
    via IV• intraoperative• 1 doses total

    Bolus 0.5 mg/kg during induction with infusion 5 µg/kg/min intraoperatively.

Methadone

active comparator

Single IV methadone dose preinduction (0.2 mg/kg).

Interventions

  • Placebo0.2 mg/kg
    via IV• preinduction single dose• 1 doses total

    Methadone 0.2 mg/kg IV preinduction (encoded under placebo compound reference as methadone is not in compound list).

Ketamine + methadone

experimental

Combination: methadone 0.2 mg/kg preinduction plus ketamine bolus 0.5 mg/kg and infusion 5 µg/kg/min intraoperatively.

Interventions

  • Ketamine0.5 mg/kg
    via IV• intraoperative• 1 doses total

    Bolus 0.5 mg/kg during induction with infusion 5 µg/kg/min intraoperatively.

  • Placebo0.2 mg/kg
    via IV• preinduction single dose• 1 doses total

    Methadone 0.2 mg/kg IV preinduction (encoded under placebo compound reference).

Participants

Ages
18 – 80
Sexes
Male & Female

Inclusion Criteria

  • Inclusion Criteria:
  • 18 - 80 years old of either gender
  • Scheduled for elective lumbar laminectomy

Exclusion Criteria

  • Exclusion Criteria:
  • American Society of Anesthesiologists (ASA) IV and above
  • Intolerance, allergy, or contraindication to use of any medications used in this study
  • Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
  • Increased intraocular pressure (e.g., untreated glaucoma)
  • Uncontrolled hypertension (BP > 140/90)
  • Sleep apnea and currently on continuous positive airway pressure (CPAP)
  • Increased intracranial pressure or clinical signs thereof
  • History of intracranial surgery, stroke, or brain aneurysm
  • Cardiac arrhythmias particularly prolonged QT syndrome
  • Drugs known to cause prolonged QT: class IA antiarrhythmics (quinidine, procainamide, disopyramide), class III antiarrhythmics (sotalol, dofetilide, ibutilide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
  • Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
  • Pregnant or lactating women
  • Emergent laminectomy
  • Those already receiving ketamine or methadone prior to surgery
  • Morbid obesity (BMI > 40 kg/m2) AND/OR weight > 150 kg
  • Chronic renal failure (creatinine > 2.0 mg/dL)
  • Liver failure e.g., active cirrhosis
  • Alcohol or substance abuse within the past 3 months
  • Uncorrected hypokalemia, hypomagnesemia, hypocalcemia
  • Chronic obstructive pulmonary disease (COPD)/Hypercarbia
  • Restrictive lung disease (pulmonary fibrosis, myasthenia gravis)
  • Congestive heart failure
  • Thyroid disease
  • Organ transplant patients
  • Drugs/substances known to inhibit methadone metabolism: macrolide antibiotics e.g., erythromycin, cimetidine, astemizole, voriconazole, grapefruit juice

Study Details

Locations

Cedars Sinai Medical Center — Los Angeles, California, United States

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