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酮咯酸氨丁三醇与丙泊酚用于焦虑儿童患者牙髓治疗的双盲随机试验。

A double blind randomized trial of ketofol versus propofol for endodontic treatment of anxious pediatric patients.

作者信息

Mittal N, Goyal A, Gauba K, Kapur A, Jain K

机构信息

Department of Pedodontics and Preventive Dentistry, Santosh Dental College and Hospital, Ghaziabad, Uttar Pradesh, India.

出版信息

J Clin Pediatr Dent. 2013 Summer;37(4):415-20. doi: 10.17796/jcpd.37.4.thv8372410714342.

DOI:10.17796/jcpd.37.4.thv8372410714342
PMID:24046993
Abstract

OBJECTIVE

To find out the safe and efficient sedative agent for primary molar pulpectomy in uncooperative pediatric patients.

STUDY DESIGN

This double blind randomized trial enrolled 40 anxious and healthy 2-6 year olds. All subjects received IV propofol (1-1.5 mg/kg) or ketofol (1-1.5 mg/kg propofol with 0.25 mg/kg ketamine) as per group assignment after oral midazolam premedication (0.5 mg/kg). Sedation maintenance was done with propofol infusion at 25-75 microg/kg/min titrated to a predefined Worse level as per Houpt's sedation rating scale. Additional bolus/es was/were administered in the dosage similar to induction dose in case of inadequate sedation. Primary outcomes were intraoperative and postoperative adverse events. Secondary outcomes were vital signs, success of procedure, operator satisfaction, sedation quality, treatment time, recovery time and total propofol dose.

RESULTS

Significantly greater incidence of respiratory depression was reported for ketofol group (11/20; 55%) when compared to propofol group (3/20; 15%) (p = 0.008). Desaturation was the most common adverse respiratory event with significantly greater incidence in ketofol group (9/20; 45%) when compared to propofol only group (3/20; 15%) (p = 0.033). No significant differences regarding secondary outcomes were reported in two groups.

CONCLUSION

Both the regimen exhibited similar sedation profile while propofol alone emerged as a safer option.

摘要

目的

找出用于不合作儿科患者乳牙牙髓摘除术的安全有效的镇静剂。

研究设计

这项双盲随机试验纳入了40名2至6岁焦虑且健康的儿童。所有受试者在口服咪达唑仑进行术前用药(0.5mg/kg)后,根据分组接受静脉注射丙泊酚(1-1.5mg/kg)或氯胺酮丙泊酚合剂(1-1.5mg/kg丙泊酚加0.25mg/kg氯胺酮)。根据豪普特镇静评分量表,以25-75μg/kg/min的速度输注丙泊酚维持镇静,滴定至预先定义的较差水平。若镇静不足,则以与诱导剂量相似的剂量给予额外推注。主要结局为术中和术后不良事件。次要结局为生命体征、手术成功率、术者满意度、镇静质量、治疗时间、恢复时间和丙泊酚总剂量。

结果

与丙泊酚组(3/20;15%)相比,氯胺酮丙泊酚合剂组(11/20;55%)报告的呼吸抑制发生率显著更高(p = 0.008)。低氧血症是最常见的不良呼吸事件,氯胺酮丙泊酚合剂组(9/20;45%)的发生率显著高于单纯丙泊酚组(3/20;15%)(p = 0.033)。两组在次要结局方面未报告显著差异。

结论

两种方案的镇静情况相似,而单独使用丙泊酚是更安全的选择。

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