Analgesic effects of low-dose ketamine after spinal fusion in adults: A protocol of prospective randomized trial

BACKGROUND: Patients with spinal fusion often have opioid tolerance and chronic pain, which makes it difficult to control postoperative pain. In this double-blind, randomized, prospective study, we assessed the safety and efficacy of intravenous low-dose ketamine for the treatment of pain in patients undergoing the lumbar spinal fusion. METHODS: This randomized, prospective, double-blind and placebo-controlled study was approved via the hospital institutional review committee. Patients were registered with signed written consent. All the floor nurses, recovery room and surgeons, patients, statisticians as well as research assistants were unaware of the grouping. The patients were randomly divided into ketamine group and control group by random number table. Nausea, vomiting or vomiting, the intensity of pain, adverse events, cumulative morphine consumption, as well as the amount of extra antiemetics or analgesics were evaluated at 6 hours, 12 hours, 24 hours, 36 hours, and 48 hours after the operation. P < .05 was considered to be the statistically significant. The Statistical Package for the software of Social Sciences 20.0 was utilized for statistical analysis. CONCLUSIONS: For the present trial, we assumed that intravenous ketamine could improve the satisfaction of patient by reducing the total consumption of morphine equivalent and the pain scores. TRIAL REGISTRATION: This study protocol was registered in Research Registry (researchregistry5896).