Kothari Meghna Anil, Shah Nimisha Chinmay, Ballal Nidambur Vasudev, Mishra Lora, Rao Ajay Singh
Department of Conservative Dentistry and Endodontics K M Shah Dental College and Hospital Sumandeep Vidyapeeth, Piparia, India.
Department of Conservative Dentistry and Endodontics Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education Karnataka, India.
Eur Endod J. 2025 Jul;10(4):278-284. doi: 10.14744/eej.2024.71473.
This double-blinded randomised clinical trial aimed to compare the efficacy of lignocaine, diclofenac sodium and ketorolac tromethamine as supplemental intraligamentary injections for intra-appointment pain in normotensive and hypertensive patients with moderate to severe symptomatic irreversible pulpitis.
Ethical clearance was obtained, and the trial was registered on the Clinical Trial Registry India (CTRI/2020/09/027635; Registered on 07/09/2020). A total of 198 patients were divided into two groups-hypertensive group (Group 1; n=99) and normotensive (healthy) group (Group 2; n=99). After computerised randomisation and double blinding, participants were subdivided into three subgroups-1A/2A: lignocaine (n=33), 1B/2B: diclofenac sodium (n=33) and 1C/2C: ketorolac tromethamine (n=33). The preoperative visual analogue scale (VAS) scores was recorded. For the hypertensive group, blood pressure was recorded, and inferior alveolar nerve block (IANB) comprising 1.8ml of 2% lignocaine without adrenaline was administered. For the normotensive group, IANB with 1.8ml of 2% lignocaine with adrenaline was administered. A supplemental intraligamentary injection comprising one of the experimental drugs was injected to both the groups. Endodontic access was gained, and the intraoperative VAS score was recorded. As part of the statistical analysis, paired t-tests, Tukey's post hoc test and ANOVA were performed using SPSS software version 20.
Supplemental intraligamentary injections of diclofenac sodium and ketorolac tromethamine showed a statistically significant difference (p<0.05) compared to lignocaine in the reduction of intraoperative pain with no side effects in hypertensive and healthy individuals.
Supplemental injections of both NSAIDs performed better than lignocaine in reducing intraoperative pain among healthy and hypertensive individuals. (EEJ-2023-06-076).
这项双盲随机临床试验旨在比较利多卡因、双氯芬酸钠和酮咯酸氨丁三醇作为补充韧带内注射剂，对患有中度至重度症状性不可逆牙髓炎的血压正常和高血压患者就诊期间疼痛的疗效。
获得伦理批准后，该试验在印度临床试验注册中心（CTRI/2020/09/027635；于2020年9月7日注册）进行注册。总共198名患者被分为两组——高血压组（第1组；n = 99）和血压正常（健康）组（第2组；n = 99）。经过计算机随机分组和双盲处理后，参与者被进一步细分为三个亚组——1A/2A：利多卡因组（n = 33），1B/2B：双氯芬酸钠组（n = 33）和1C/2C：酮咯酸氨丁三醇组（n = 33）。记录术前视觉模拟量表（VAS）评分。对于高血压组，记录血压，并给予含1.8毫升不含肾上腺素的2%利多卡因的下牙槽神经阻滞（IANB）。对于血压正常组，给予含1.8毫升含肾上腺素的2%利多卡因的IANB。向两组均注射一种实验药物组成的补充韧带内注射剂。开通牙髓通路，并记录术中VAS评分。作为统计分析的一部分，使用SPSS 20.0软件进行配对t检验、Tukey事后检验和方差分析。
与利多卡因相比，双氯芬酸钠和酮咯酸氨丁三醇的补充韧带内注射在降低术中疼痛方面具有统计学显著差异（p < 0.05），且在高血压和健康个体中均无副作用。
在健康和高血压个体中，两种非甾体抗炎药的补充注射在减轻术中疼痛方面比利多卡因表现更好。（EEJ - 2023 - 06 - 076）
