Rikke Vibeke Nielsen1, Jonna Storm Fomsgaard1, Lone Nikolajsen2, Jørgen Berg Dahl3, Ole Mathiesen4. 1. Department of Neuroanesthesiology, Rigshospitalet - Glostrup, Copenhagen University Hospital, Glostrup, Denmark. 2. Department of Anesthesiology and Intensive Care, Aarhus University Hospital, Aarhus, Denmark. 3. Department of Anesthesiology, Bispebjerg University Hospital, Copenhagen, Denmark. 4. Department of Anesthesiology, Zealand University Hospital Koege, Koege, Denmark.
Abstract
BACKGROUND: We aimed to explore the effect of intraoperative S-ketamine on analgesic consumption and pain one yearafter spine surgery in chronic opioid-dependent patients undergoing spinal fusion surgery. METHODS: Single-centre, randomized, blinded trial of 147 patients. INTERVENTION: Perioperative S-ketamine bolus 0.5 mg/kg followed by S-ketamine 0.25 mg kg-1 hr-1 infusion or placebo. MAIN OUTCOMES: Analgesic use, pain (visual analogue scale 0-100 mm [VAS]) and labour market attachment one year after surgery assessed by written questionnaires. RESULTS:Response rate was 67%. One year after surgery, the daily use of oral morphine equivalents was lower in the ketamine group versus the placebo group: 0 (0-20) mg versus 20 (0-62) mg, (p = 0.02), and fewer patients had a daily use of any analgesics in the ketamine group versus placebo group, 42% (95% CI 23-61) versus 74% (95% CI 58-87), (p = 0.04). Mobilization pain was lower in the ketamine group compared to the placebo group: Median difference 17 mm (95% CI -30 to -3), (p = 0.02). Pain at rest was lower in the ketamine group compared to the placebo group with median difference: 13 mm (95% CI -23 to -3), (p = 0.01). Further, labour market attachment was better in the ketamine group, (p = 0.02). CONCLUSION:Intraoperative ketamine may reduce analgesic use, pain, and improve labour market attachment one year after spine surgery in a chronic opioid-dependent population. SIGNIFICANCE: This randomized clinical trial shows that intraoperative ketamine may reduce opioid use and pain and improve labour market attachmentone year after spine surgery in an opioid-dependent population.
RCT Entities:
BACKGROUND: We aimed to explore the effect of intraoperative S-ketamine on analgesic consumption and pain one year after spine surgery in chronic opioid-dependent patients undergoing spinal fusion surgery. METHODS: Single-centre, randomized, blinded trial of 147 patients. INTERVENTION: Perioperative S-ketamine bolus 0.5 mg/kg followed by S-ketamine 0.25 mg kg-1 hr-1 infusion or placebo. MAIN OUTCOMES: Analgesic use, pain (visual analogue scale 0-100 mm [VAS]) and labour market attachment one year after surgery assessed by written questionnaires. RESULTS: Response rate was 67%. One year after surgery, the daily use of oral morphine equivalents was lower in the ketamine group versus the placebo group: 0 (0-20) mg versus 20 (0-62) mg, (p = 0.02), and fewer patients had a daily use of any analgesics in the ketamine group versus placebo group, 42% (95% CI 23-61) versus 74% (95% CI 58-87), (p = 0.04). Mobilization pain was lower in the ketamine group compared to the placebo group: Median difference 17 mm (95% CI -30 to -3), (p = 0.02). Pain at rest was lower in the ketamine group compared to the placebo group with median difference: 13 mm (95% CI -23 to -3), (p = 0.01). Further, labour market attachment was better in the ketamine group, (p = 0.02). CONCLUSION: Intraoperative ketamine may reduce analgesic use, pain, and improve labour market attachment one year after spine surgery in a chronic opioid-dependent population. SIGNIFICANCE: This randomized clinical trial shows that intraoperative ketamine may reduce opioid use and pain and improve labour market attachment one year after spine surgery in an opioid-dependent population.
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