This Phase IV interventional trial (n=13; terminated) aimed to assess the pain-reducing effects of ketamine and methadone after lumbar laminectomy.
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.
IV ketamine bolus during induction (0.5 mg/kg) with intraoperative IV ketamine infusion (5 µg/kg/min).
Bolus 0.5 mg/kg during induction with infusion 5 µg/kg/min intraoperatively.
Single IV methadone dose preinduction (0.2 mg/kg).
Methadone 0.2 mg/kg IV preinduction (encoded under placebo compound reference as methadone is not in compound list).
Combination: methadone 0.2 mg/kg preinduction plus ketamine bolus 0.5 mg/kg and infusion 5 µg/kg/min intraoperatively.
Bolus 0.5 mg/kg during induction with infusion 5 µg/kg/min intraoperatively.
Methadone 0.2 mg/kg IV preinduction (encoded under placebo compound reference).