Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, People's Republic of China.
Trials. 2021 Nov 13;22(1):800. doi: 10.1186/s13063-021-05774-9.
Postoperative pain is a common problem that occurs in pediatric patients following neurosurgery which may lead to severe complications. Dexmedetomidine is a commonly used adjuvant medicine in craniotomy owing to its sedative, amnestic, analgesic, and neuroprotective properties. Besides, studies suggest that lidocaine has similar effects on sedation, analgesia, and neuroprotection. Both two adjuvants can reduce postoperative pain after neurosurgery in adults. However, it is still unknown whether dexmedetomidine or lidocaine can reduce postoperative pain in children undergoing craniotomy, and if yes, which is a better medicine choice. Therefore, we aimed to compare the effect of dexmedetomidine vs. lidocaine on postoperative pain in pediatric patients after craniotomy.
METHODS/DESIGN: We will perform a randomized (1:1:1), double-blind, placebo-controlled, single-center trial. Children aged 1-12 years scheduled for craniotomy will be eligible for inclusion. The 255 recruited participants will be stratified by age in two strata (1-6 years and 7-12 years), and then each stratum will be equally randomized to three groups: group D (infusion of dexmedetomidine [intervention group]), group L (infusion of lidocaine [intervention group]), and group C (infusion of normal saline [control group]). Patients will be followed up at 1 h, 2 h, 4 h, 24 h, and 48 h after surgery. The primary outcome will be total sufentanil consumption within 24 h after surgery.
In this clinical trial, we expect to clarify and compare the postoperative analgesic effect of dexmedetomidine vs. lidocaine infusion on pediatric patients undergoing craniotomy. We believe that the results of this trial will provide more choices for postoperative analgesia for the pediatric population.
Chinese ClinicalTrials.gov ChiCTR1800019411 . Registered on 10 November 2018.
术后疼痛是小儿神经外科手术后常见的问题，可能导致严重的并发症。右美托咪定是开颅术中常用的辅助药物，具有镇静、遗忘、镇痛和神经保护作用。此外，研究表明利多卡因在镇静、镇痛和神经保护方面也有类似的作用。这两种辅助药物都可以减少成人神经外科手术后的术后疼痛。然而，目前尚不清楚右美托咪定或利多卡因是否可以减轻行开颅术的儿童的术后疼痛，如果可以，哪种药物更好。因此，我们旨在比较右美托咪定与利多卡因对行开颅术的小儿患者术后疼痛的影响。
方法/设计：我们将进行一项随机（1:1:1）、双盲、安慰剂对照、单中心试验。年龄在 1-12 岁、拟行开颅术的儿童将有资格入组。将 255 名入选的参与者按年龄分为两个亚组（1-6 岁和 7-12 岁），然后每个亚组等分为三组：D 组（输注右美托咪定[干预组]）、L 组（输注利多卡因[干预组]）和 C 组（输注生理盐水[对照组]）。患者将在术后 1h、2h、4h、24h 和 48h 进行随访。主要结局为术后 24h 内舒芬太尼的总消耗量。
在这项临床试验中，我们期望阐明并比较右美托咪定与利多卡因输注对行开颅术的小儿患者的术后镇痛效果。我们相信，该试验的结果将为小儿人群的术后镇痛提供更多选择。
中国临床试验注册中心 ChiCTR1800019411 号。于 2018 年 11 月 10 日注册。
