口服咪达唑仑复合笑气镇静治疗儿童牙科恐惧症的临床疗效观察
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摘要
目的评估口服咪达唑仑复合笑气吸入镇静治疗儿童牙科恐惧症的安全性和有效性。方法以在北京协和医院口腔科就诊、Frankl量表评分为1分的77例患儿为研究对象,其中41例(咪达唑仑组)进行了78人次的口服咪达唑仑(0. 50～0. 75 mg·kg~(-1))镇静下治疗,36例(咪达唑仑复合笑气组)进行了73人次的口服咪达唑仑(0. 40 mg·kg~(-1))复合30%～40%笑气吸入下镇静治疗。记录患儿的心率、血氧饱和度、治疗内容等。采用Frankl量表评估患儿治疗中的行为,Houpt量表评估患儿治疗完成情况,Ramsay量表评估治疗中儿童的镇静状态,治疗结束24 h后电话回访不良反应。结果 77例患儿生命体征平稳、安全,Ramsay评分为2分或3分。咪达唑仑组78人次治疗中,52人次(66. 7%)的行为为合作,26人次(33. 3%)的行为为不合作,62人次(79. 5%)完成了既定治疗,16人次(20. 5%)镇静效果不理想,仅完成部分治疗;咪达唑仑复合笑气组73人次治疗中,56人次(76. 7%)的行为为合作,17人次(23. 3%)的行为为不合作,64人次(87. 7%)完成了既定治疗,9人次(12. 3%)仅完成部分治疗;两组患儿的镇静成功率(X~2=1. 87,P=0. 17)和治疗成功率(X~2=1. 83,P=0. 18)差异无统计学意义。咪达唑仑复合笑气组的中位Frankl分值[3 (3,4)分]明显高于咪达唑仑组[3 (2,4)分](Z=2. 647,P=0. 008)。咪达唑仑复合笑气组的中位Houpt分值[5 (4,6)分]也明显高于咪达唑仑组[5 (3,5)分](Z=2. 236,P=0. 026)。咪达唑仑组78人次治疗中,烦躁不安7人次,复视3人次,呃逆2人次;咪达唑仑复合笑气组73人次治疗中,烦躁不安5人次,复视5人次,呃逆1人次,呕吐2人次;两组不良反应的发生率分别为15. 4%和17. 8%,差异无统计学意义(X~2=0. 160,P=0. 689)。Logistic回归分析结果显示,性别(OR=1. 704,P=0. 174)、剂量(OR=1. 289,P=0. 516)和治疗内容(OR=0. 555,P=0. 143)对治疗成功率均无明显影响;年龄是治疗成功率的影响因素,3岁以上儿童的治疗成功率明显高于3岁以下儿童(OR=3. 372,P=0. 011)。结论口服咪达唑仑治疗牙科恐惧症儿童是一种安全有效的方法,口服咪达唑仑复合笑气可以明显改善患者在治疗中的行为。3岁以上儿童效果较好。
Objective To evaluate the safety and effectiveness of oral midazolam sedation combined nitrous oxide sedation for reducing dental fear in children. Methods Totally 77 children with a Frankl's Behavior Rating Scale score of 1 were included in this study,among whom 41 received a total of 78 person-times of oral midazolam sedation( 0. 50-0. 75 mg·kg~(-1))( midazolam group) and 36 children were treated with the combination of 0. 4 mg/kg oral midazolam with 30%-40% nitrous oxide( totally 73 person-times)( combination group).At each visit,heart rate,arterial oxygen saturation,and treatments were recorded. The behaviors of children during the treatment were assessed by Frankl's Behavior Rating Scale,the completion of treatment was assessed by Houpt Scale,and the sedation status was assessed by Ramsay Scale. Telephone follow-up was performed to record the side effects 24 hours after treatment. Results The vital signs were stable among all the 77 subjects,with a Ramsay score of 2 or 3. In the midazolam group,the behaviors were cooperative in 52 person-times( 66. 7%) and not cooperative in 26 person-times( 33. 3%); the planned treatments were completed in 62 person-times( 79. 5%) and partially completed in 16 person-times( 20. 5%). In the combination group,the behaviors were cooperative in 56 person-times( 76. 7%) and not cooperative in 17 person-times( 23. 3%); 64 person-times( 87. 7%) completed the planned treatments and 9 person-times( 12. 3%) partially completed the treatments. The success rates of sedation( X~2= 1. 87,P = 0. 17) and treatment( X~2= 1. 83,P = 0. 18) were not significantly different between these two groups. The median Frankl scale score was significantly higher in the combination group [3( 3,4) ]than in the midazolam group [3( 2,4) ]( Z = 2. 647,P = 0. 008]. The median score of Houpt scale in the combination group [5( 4,6) ]was also significantly higher than in midazolam group [5( 3,5) ]( Z = 2. 236,P = 0. 026]. In midazolam group,there were 7 person-times of dysphoria,3 person-times of diplopia,and 2 person-times of hiccough among 78 person-times; in the combination group,there were 5 person-times of dysphoria,5 person-times of diplopia,1 person-time of hiccough,and 2 persontimes of vomit among 73 person-times of treatment. Thus,there was no significant difference in the incidence of side effects( 15. 4% vs. 17. 8%,X~2= 0. 160,P = 0. 689). Logistic regression analysis showed that the success rate of treatment was not associated with sex( OR = 1. 704,P = 0. 174),dose( OR = 1. 289,P = 0. 516),and treatment types( OR = 0. 555,P = 0. 143). Children over 3 years old had a significantly high success rate than those under 3 years old( OR = 3. 372,P = 0. 011). Conclusions Oral midazolam is safe and effective for reducing dental fear in children. The combination of oral midazolam with 30%-40% nitrous oxide can improve the behaviors of children during the dental treatment,especially in children over 3 years old.
Objective To evaluate the safety and effectiveness of oral midazolam sedation combined nitrous oxide sedation for reducing dental fear in children. Methods Totally 77 children with a Frankl's Behavior Rating Scale score of 1 were included in this study,among whom 41 received a total of 78 person-times of oral midazolam sedation( 0. 50-0. 75 mg·kg~(-1))( midazolam group) and 36 children were treated with the combination of 0. 4 mg/kg oral midazolam with 30%-40% nitrous oxide( totally 73 person-times)( combination group).At each visit,heart rate,arterial oxygen saturation,and treatments were recorded. The behaviors of children during the treatment were assessed by Frankl's Behavior Rating Scale,the completion of treatment was assessed by Houpt Scale,and the sedation status was assessed by Ramsay Scale. Telephone follow-up was performed to record the side effects 24 hours after treatment. Results The vital signs were stable among all the 77 subjects,with a Ramsay score of 2 or 3. In the midazolam group,the behaviors were cooperative in 52 person-times( 66. 7%) and not cooperative in 26 person-times( 33. 3%); the planned treatments were completed in 62 person-times( 79. 5%) and partially completed in 16 person-times( 20. 5%). In the combination group,the behaviors were cooperative in 56 person-times( 76. 7%) and not cooperative in 17 person-times( 23. 3%); 64 person-times( 87. 7%) completed the planned treatments and 9 person-times( 12. 3%) partially completed the treatments. The success rates of sedation( X~2= 1. 87,P = 0. 17) and treatment( X~2= 1. 83,P = 0. 18) were not significantly different between these two groups. The median Frankl scale score was significantly higher in the combination group [3( 3,4) ]than in the midazolam group [3( 2,4) ]( Z = 2. 647,P = 0. 008]. The median score of Houpt scale in the combination group [5( 4,6) ]was also significantly higher than in midazolam group [5( 3,5) ]( Z = 2. 236,P = 0. 026]. In midazolam group,there were 7 person-times of dysphoria,3 person-times of diplopia,and 2 person-times of hiccough among 78 person-times; in the combination group,there were 5 person-times of dysphoria,5 person-times of diplopia,1 person-time of hiccough,and 2 persontimes of vomit among 73 person-times of treatment. Thus,there was no significant difference in the incidence of side effects( 15. 4% vs. 17. 8%,X~2= 0. 160,P = 0. 689). Logistic regression analysis showed that the success rate of treatment was not associated with sex( OR = 1. 704,P = 0. 174),dose( OR = 1. 289,P = 0. 516),and treatment types( OR = 0. 555,P = 0. 143). Children over 3 years old had a significantly high success rate than those under 3 years old( OR = 3. 372,P = 0. 011). Conclusions Oral midazolam is safe and effective for reducing dental fear in children. The combination of oral midazolam with 30%-40% nitrous oxide can improve the behaviors of children during the dental treatment,especially in children over 3 years old.
引文
[1] Tyagi P,Tyagi S,Jain A. Sedative effects of oral midazolam,intravenous midazolam and oral diazepam in the dental treat-ment of children[J]. J Clin Pediatr Dent,2013,37(3):301-305. DOI:10. 17796/jcpd. 37. 3. 6u482603r0388558.
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[3] Galeotti A,Garret Bernardin A,D’Anto V,et al. Inhala-tion conscious sedation with nitrous oxide and oxygen as alter-native to general anesthesia in precooperative,fearful,anddisabled pediatric dental patients:a large survey on 688 workingsessions[J]. Biomed Res Int,2016,2016:7289310. DOI:10. 1155/2016/7289310.
[4] Papineni A,Lourenco-Matharu L,Ashley PF. Safety of oralmidazolam sedation use in paediatric dentistry:a review[J].Int J Paediatr Dent,2014,24(1):2-13. DOI:10. 1111/ipd. 12017.
[5] Peretz B,Kharouba J,Somri M. A comparison of two differ-ent dosages of oral midazolam in the same pediatric dental pa-tients[J]. Pediatr Dent,2014,36(3):228-232.
[6] Somri M,Parisinos CA,Kharouba J,et al. Optimising thedose of oral midazolam sedation for dental procedures in chil-dren:a prospective,randomised,and controlled study[J].Int J Paediatr Dent,2012,22(4):271-279. DOI:10. 1111/j. 1365-263X. 2011. 01192. x.
[7] Al-Zahrani AM,Wyne AH,Sheta SA. Comparison of oralmidazolam with combination of oral midazolam and nitrous ox-ide inhalation in relation to safety of dental sedation in youngchildren[J]. Odontostomatol Trop,2011,34(135):33-41.
[8] Houpt MI,Weiss NJ,Koenigsberg SR,et al. Comparisonof chloral hydrate with and without promethazine in the seda-tion of young children[J]. Pediatr Dent,1985,7(1):41-46.
[9] Guideline for monitoring and management of pediatric patientsbefore,during,and after sedation for diagnostic and therapeuticprocedures:update 2016[J]. Pediatr Dent,2016,38(5):77-106.
[10] Musani IE,Chandan NV. A comparison of the sedative effectof oral versus nasal midazolam combined with nitrous oxide inuncooperative children[J]. Eur Arch Paediatr Dent,2015,16(5):417-424. DOI:10. 1007/s40368-015-0187-7.
[11] Ozen B,Malamed SF,Cetiner S,et al. Outcomes of mod-erate sedation in paediatric dental patients[J]. Aust Dent J,2012,57(2):144-150. DOI:10. 1111/j. 1834-7819. 2012.01673. x.
[12] Brosius KK,Bannister CF. Midazolam premedication in chil-dren:a comparison of two oral dosage formulations on seda-tion score and plasma midazolam levels[J]. Anesth Analg,2003,96(2):392-395. DOI:10. 1213/00000539-200302000-00017.
[13] Salem K,Khoshrang H,Kousha M,et al. Efficacy andsafety of orally administered intravenous midazolam versus acommercially prepared syrup[J]. Iran J Pediatr,2015,25(3):e494. DOI:10. 5812/ijp. 25(3)2015. 494.
[14]侯雪莹.咪达唑仑糖浆混合液稳定性研究[C].北京:中国医学科学院北京协和医学院,2017.
[15] Lourenco-Matharu L,Ashley PF,Furness S. Sedation of chil-dren undergoing dental treatment[J]. Cochrane DatabaseSyst Rev,2012(3):CD003877. DOI:10. 1002/14651858.CD003877. pub4.
[16]马林,景泉,万阔.口服咪达唑仑治疗牙科恐惧症儿童的临床疗效观察[J].华西口腔医学杂志,2012,30(3):271-274. DOI:10. 3969/j. issn. 1000-1182. 2012. 03. 012.
[2] Antunes DE,Viana KA,Costa PS,et al. Moderate seda-tion helps improve future behavior in pediatric dental patients-a prospective study[J]. Braz Oral Res,2016,30(1):e107.DOI:10. 1590/1807-3107BOR-2016. vol30. 0107.
[3] Galeotti A,Garret Bernardin A,D’Anto V,et al. Inhala-tion conscious sedation with nitrous oxide and oxygen as alter-native to general anesthesia in precooperative,fearful,anddisabled pediatric dental patients:a large survey on 688 workingsessions[J]. Biomed Res Int,2016,2016:7289310. DOI:10. 1155/2016/7289310.
[4] Papineni A,Lourenco-Matharu L,Ashley PF. Safety of oralmidazolam sedation use in paediatric dentistry:a review[J].Int J Paediatr Dent,2014,24(1):2-13. DOI:10. 1111/ipd. 12017.
[5] Peretz B,Kharouba J,Somri M. A comparison of two differ-ent dosages of oral midazolam in the same pediatric dental pa-tients[J]. Pediatr Dent,2014,36(3):228-232.
[6] Somri M,Parisinos CA,Kharouba J,et al. Optimising thedose of oral midazolam sedation for dental procedures in chil-dren:a prospective,randomised,and controlled study[J].Int J Paediatr Dent,2012,22(4):271-279. DOI:10. 1111/j. 1365-263X. 2011. 01192. x.
[7] Al-Zahrani AM,Wyne AH,Sheta SA. Comparison of oralmidazolam with combination of oral midazolam and nitrous ox-ide inhalation in relation to safety of dental sedation in youngchildren[J]. Odontostomatol Trop,2011,34(135):33-41.
[8] Houpt MI,Weiss NJ,Koenigsberg SR,et al. Comparisonof chloral hydrate with and without promethazine in the seda-tion of young children[J]. Pediatr Dent,1985,7(1):41-46.
[9] Guideline for monitoring and management of pediatric patientsbefore,during,and after sedation for diagnostic and therapeuticprocedures:update 2016[J]. Pediatr Dent,2016,38(5):77-106.
[10] Musani IE,Chandan NV. A comparison of the sedative effectof oral versus nasal midazolam combined with nitrous oxide inuncooperative children[J]. Eur Arch Paediatr Dent,2015,16(5):417-424. DOI:10. 1007/s40368-015-0187-7.
[11] Ozen B,Malamed SF,Cetiner S,et al. Outcomes of mod-erate sedation in paediatric dental patients[J]. Aust Dent J,2012,57(2):144-150. DOI:10. 1111/j. 1834-7819. 2012.01673. x.
[12] Brosius KK,Bannister CF. Midazolam premedication in chil-dren:a comparison of two oral dosage formulations on seda-tion score and plasma midazolam levels[J]. Anesth Analg,2003,96(2):392-395. DOI:10. 1213/00000539-200302000-00017.
[13] Salem K,Khoshrang H,Kousha M,et al. Efficacy andsafety of orally administered intravenous midazolam versus acommercially prepared syrup[J]. Iran J Pediatr,2015,25(3):e494. DOI:10. 5812/ijp. 25(3)2015. 494.
[14]侯雪莹.咪达唑仑糖浆混合液稳定性研究[C].北京:中国医学科学院北京协和医学院,2017.
[15] Lourenco-Matharu L,Ashley PF,Furness S. Sedation of chil-dren undergoing dental treatment[J]. Cochrane DatabaseSyst Rev,2012(3):CD003877. DOI:10. 1002/14651858.CD003877. pub4.
[16]马林,景泉,万阔.口服咪达唑仑治疗牙科恐惧症儿童的临床疗效观察[J].华西口腔医学杂志,2012,30(3):271-274. DOI:10. 3969/j. issn. 1000-1182. 2012. 03. 012.