术前口服布洛芬对种植体植入术后疼痛影响的随机对照研究

Effect of preoperative oral ibuprofen on postoperative pain after dental implantation:a randomized controlled trial

目的评价术前口服布洛芬的超前镇痛方案对单枚后牙种植体植入术后疼痛的影响。方法采用多中心、随机、双盲、安慰剂平行对照的试验设计。按照纳排标准收集2022年4月至2024年4月于首都医科大学口腔医学院(40例)、首都医科大学附属北京天坛医院(22例)及首都医科大学附属北京朝阳医院(20例)就诊的要求植入种植体的患者。采用简单随机方法将患者按照1∶1的比例分配至布洛芬组和对照组,每组41例。布洛芬组与对照组分别于术前15 min口服300 mg布洛芬缓释胶囊和安慰剂,并在术后3 d内接受相同的镇痛方案。通过数字评定量表(NRS)统计患者术后30 min和4、6、8、24、48、72 h的疼痛评分,并记录术后4~6 d额外镇痛药使用量。结果研究共入组82例患者,失访脱落7例(对照组4例、布洛芬组3例),共计75例(对照组37例、布洛芬组38例)患者完成试验,患者均未发生恶心、呕吐等不良事件。布洛芬组患者术后4、6、8 h的疼痛评分[分别为1.0(0.0,2.0)、1.0(0.0,2.0)、1.5(0.0,3.0)分]均显著低于对照组[分别为2.0(1.0,3.0)、3.0(1.5,4.0)、2.0(1.0,4.0)分](Z=-1.99,P=0.047;Z=-3.01,P=0.003;Z=-2.10,P=0.036)。布洛芬组与对照组分别有18.4%(7/38)和27.0%(10/37)的患者于术后4~6 d额外服用镇痛药,两者额外服用镇痛药的患者比例差异无统计学意义(χ^(2)=0.79,P=0.373);对照组与布洛芬组术后额外用药量分别为[0.0(0.0,1.0)粒]与[0.0(0.0,0.0)粒],差异无统计学意义(Z=-0.78,P=0.439)。结论布洛芬超前镇痛可有效降低患者种植体植入术后疼痛程度,是一种安全有效的围手术期疼痛管理方案。

Objective To evaluate the effect of preemptive analgesia with ibuprofen on postoperative pain following single posterior tooth implantation,aiming to provide a clinical reference for its application.Methods A multicenter,randomized,double-blind,placebo-controlled parallel-group trial was conducted.A total of 82 participants were included in the trial,meeting the eligibility criteria from April 2022 to April 2024 at the Capital Medical University School of Stomatology(40 cases),Beijing TianTan Hospital,Capital Medical University(22 cases),Beijing Chao-Yang Hospital,Capital Medical University(20 cases).Participants were randomly assigned in a 1∶1 ratio to either the ibuprofen group or the control group,with each group comprising 41 individuals.Participants in the ibuprofen group received 300 mg of sustained-release ibuprofen capsules orally 15 min before surgery,while the control group received a placebo.Both groups received the same postoperative analgesic regimen for 3 days.Pain scores were assessed using the numerical rating scale at 30 min,4 h,6 h,8 h,24 h,48 h,and 72 h postoperatively,and the additional use of analgesic medication was recorded from days 4 to 6 postoperatively.Results A total of 82 participants were initially enrolled in the study,with 7 dropouts(4 from the control group and 3 from the ibuprofen group),resulting in 75 participants(37 in the control group and 38 in the ibuprofen group)completing the trial.There were no reports of adverse events such as nausea or vomiting among the participants.The ibuprofen group exhibited significantly lower pain scores at 4 h,6 h and 8 h[1.0(0.0,2.0),1.0(0.0,2.0),1.5(0.0,3.0)]postoperatively compared to the control group 4 h,6 h and 8 h[2.0(1.0,3.0),3.0(1.5,4.0),2.0(1.0,4.0)](Z=-1.99,P=0.047;Z=-3.01,P=0.003;Z=-2.10,P=0.036).The proportions of patients requiring additional analgesic medication between days 4 and 6 post-surgery were 18.4%(7/38)in the ibuprofen group and 27.0%(10/37)in the control group,with no significant difference(χ^(2)=0.79,P=0.373).The median additional medication usage postoperatively was[0.0(0.0,0.0)pills]in the ibuprofen group and[0.0(0.0,1.0)pills]in the control group,with no significant difference(Z=-0.78,P=0.439).Conclusions Preemptive analgesia with ibuprofen effectively reduces postoperative pain following tooth implantation,representing a safe and effective perioperative pain management strategy.