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口服与鼻内咪达唑仑联合一氧化二氮对不合作儿童镇静效果的比较。

A comparison of the sedative effect of oral versus nasal midazolam combined with nitrous oxide in uncooperative children.

作者信息

Musani I E, Chandan N V

机构信息

Department of Pediatric and Preventive Dentistry, M.A. Rangoonwala Dental College and Research Centre, Pune, 2390-B, K.B. Hidayatullah Road, Azam Campus, Camp, Pune, 411001, Maharashtra, India.

出版信息

Eur Arch Paediatr Dent. 2015 Oct;16(5):417-24. doi: 10.1007/s40368-015-0187-7. Epub 2015 May 5.

Abstract

AIM

To compare a combination of oral midazolam (0.2 mg/kg body weight) and nitrous oxide-oxygen sedation with a combination of intranasal midazolam (0.1 mg/kg body weight) and nitrous oxide-oxygen sedation for effectiveness, patient acceptability and safety profile in controlling the behaviour of uncooperative children.

METHODS

Thirty children, 4-10 years of age, referred for dental treatment were included in the study with a crossover design. Each patient was sedated with a combination of either oral midazolam and nitrous oxide-oxygen sedation or intranasal midazolam and nitrous oxide-oxygen sedation at subsequent dental treatment visits. During the treatment procedure, the study recorded scales for drug acceptability, onset of sedation, acceptance of nasal mask, sedation, behavioural, safety, overall behaviour and alertness.

RESULTS

The grade of acceptability of midazolam in both groups was consistently good. There was a significant difference (p < 0.001) in the time of onset of sedation, which was significantly quicker with the intranasal administration of midazolam. The mean time of onset for oral midazolam was 20.1 (17-25) min and for intranasal midazolam 12.1 (8-18) min. The efficacy profile of the present study included: acceptance of nasal mask, sedation score, crying levels, motor movements and overall behaviour scores. The results did not show any statistically significant differences. All the parameters were highly satisfactory. The difference in alertness was statistically significant (p value <0.05), being higher in the intranasal group than the oral group and suggestive of faster recovery using intranasal midazolam.

CONCLUSION

The intranasal route of midazolam administration has a quick onset of action and a quick recovery of the patient from sedation as compared to the oral route of midazolam administration. Midazolam administered through the intranasal route is as effective as the oral route at a lower dosage. Therefore, it is an effective alternative to oral route for a paediatric dental situation.

摘要

目的

比较口服咪达唑仑(0.2mg/kg体重)与氧化亚氮-氧气镇静联合使用,和鼻内给予咪达唑仑(0.1mg/kg体重)与氧化亚氮-氧气镇静联合使用,在控制不合作儿童行为方面的有效性、患者可接受性和安全性。

方法

采用交叉设计,对30名4至10岁因牙科治疗前来就诊的儿童进行研究。每位患者在后续的牙科治疗就诊时,分别接受口服咪达唑仑与氧化亚氮-氧气镇静联合治疗,或鼻内给予咪达唑仑与氧化亚氮-氧气镇静联合治疗。在治疗过程中,研究记录了药物可接受性、镇静起效时间、鼻罩接受度、镇静程度、行为表现、安全性、总体行为和警觉性等指标。

结果

两组中咪达唑仑的可接受程度一直良好。镇静起效时间存在显著差异(p<0.001),鼻内给予咪达唑仑的起效时间明显更快。口服咪达唑仑的平均起效时间为20.1(17 - 25)分钟,鼻内给予咪达唑仑的平均起效时间为12.1(8 - 18)分钟。本研究的疗效指标包括:鼻罩接受度、镇静评分、哭闹程度、运动动作和总体行为评分。结果未显示出任何统计学上的显著差异。所有参数都非常令人满意。警觉性方面的差异具有统计学意义(p值<0.05),鼻内给药组高于口服给药组,提示鼻内给予咪达唑仑后患者恢复更快。

结论

与口服咪达唑仑相比,鼻内给予咪达唑仑起效迅速,患者从镇静状态恢复也快。通过鼻内途径给予较低剂量的咪达唑仑与口服途径同样有效。因此,在儿童牙科治疗中,它是口服途径的一种有效替代方法。

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