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Mini-dose esketamineedexmedetomidine combination to supplement analgesia for patients after scoliosis correction surgery: a double-blind randomised trial

June 9, 2023

Background:
Patients often experience severe pain after scoliosis correction surgery. Esketamine and dexmedetomidine each improves analgesia but can produce side-effects. We therefore tested the hypothesis that a mini-dose esketamine- dexmedetomidine combination safely improves analgesia.
Methods:
Two hundred male and female adults having scoliosis correction surgery were randomised to patient- controlled sufentanil analgesia (4 mg kg1 in normal saline) with either a combined supplement (esketamine 0.25 mg ml1 and dexmedetomidine 1 mg ml1 ) or placebo. The primary outcome was the incidence of moderate-to-severe pain within 72 h, defined as a numeric rating scale (NRS: 0¼no pain and 10¼worst pain) score 4 at any of seven time points. Amongst secondary outcomes, subjective sleep quality was assessed with an NRS score (0¼best sleep and 10¼worst sleep) for the first five postoperative nights.
Results:
There were 199 subjects included in the intention-to-treat analysis. Mean infusion rates were 5.5 mg kg1 h1 for esketamine and 0.02 mg kg1 h1 for dexmedetomidine. The primary outcome incidence was lower with the combined supplement (65.7% [65/99]) than with placebo (86.0% [86/100]; relative risk 0.76; 95% confidence interval: 0.65e0.90; P¼0.001). Subjects given the combined supplement had lower pain intensity at rest at five time points (median difference e1 point; P0.005), lower pain intensity with movement at six time points (median difference e1 point; P0.001), and better subjective sleep quality for the first 5 postoperative nights (median difference e2 to e1 points; P<0.001). Adverse events did not differ between groups. Conclusions:
The mini-dose esketamineedexmedetomidine combination safely improved analgesia and subjective sleep quality after scoliosis correction surgery.
Clinical trial registration: NCT04791059.
Keywords:
analgesia; dexmedetomidine; esketamine; S(þ)-ketamine; multimodal analgesia; postoperative analgesia; scoliosis surgery; spine.