http://dx.doi.org/10.5933/jkapd.2015.42.4.331 ISSN (print) 1226-8496 ISSN (online) 2288-3819 A Review of the Systemic Analysis Method on Dental Sedation for Children Soyoun An 1, Jewoo Lee 1, Seungoh Kim 2, Jongbin Kim 3 1 Department of Pediatric Dentistry, College of Dentistry, Wonkwang University 2 Department of Dental Anesthesiology, School of Dentistry, Dankook University 3 Department of Pediatric Dentistry, School of Dentistry, Dankook University Abstract The first priority of sedation for incorporative children in pediatric dentistry is a safety. Therefore, evidencebased practices in health care are needed for preventing medical accidents. In accordance with the rise of the evidence based medicine, the interest in Evidence-Based Dentistry is increasing in the field of dentistry. However, systematic research about Evidence-Based sedation in Korea has rarely been done. As such, the purpose of this systematic review is to critically analyze the available scientific literature regarding dental sedation and to seek the next developmental strategies about evidence based pediatric dental sedation. A broad search of the 5 databases of the systematic reviews manual of the National Evidence-based Healthcare Collaborating Agency in Korea were referenced: 1) Core search database- KMbase, KISS; 2) Academic information and portal; 3) the National Assembly Library; 4) DBpia, and 5) RISS. Of a total 470 themes limited to the search term of dental sedation, in accordance with the PRISMA statement for reporting systematic reviews of health sciences interventions, a literature selection process, which includes the removal of overlapping down the flow chart, was performed. Of the remaining 31 articles, two authors read through articles independently and added or removed articles using the exclusion criteria. Finally, twenty published papers of acceptable quality were identified and reviewed. This systemic review of Korean pediatric dental sedation practices for the last twenty-five years was based on the objective criteria defined in the GRADE process and identified consistent evidence. The results were evidence of moderate quality. Therefore, more systemically well-designed clinical studies are needed about the safe use of a sedative medicines (drugs). Key words : Evidence-based medicine, Systemic review, Dental sedation, Korea, Children Ⅰ. 서론치과진료를위해치과에방문하는어린이들은본능적인공포를가진다. 그런공포를경감해주기위해진정법은유용한수단이될수있으나그에따른대비가반드시필요하다 1). Klingberg 등 2) 은호주, 캐나다, 유럽, 미국의어린이중 9% 가치과진료시공포, 불안감, 행동관리문제를경험한다고보고 하였다. 치과에대한공포 (Dental fear, DF) 란치과에서경험하는특정자극에대한무서움을뜻하며, 불안감 (Dental anxiety, DA) 이란진료에대한막연한두려움으로이두가지용어는흔히혼용되며, 치과에대한부정적인느낌을공포와불안감 (Dental fear and anxiety, DFA) 으로표현하였다. 그리고치과진료시의비협조적인행동으로인한행동관리문제 (Dental behavior management problems, DBMP) 는치료 Corresponding author : Jongbin Kim Department of Pediatric Dentistry, School of Dentistry, Dankook University, 119 Dandaero, Dongnam-gu, Cheonan, 31116, Korea Tel: +82-41-550-1921 / Fax: +82-41-550-0118 / E-mail: jbkim0222@dankook.ac.kr Received October 23, 2015 / Revised November 6, 2015 / Accepted Nobember 5, 2015 331
를지연시키거나치료를불가능하게하기도한다고하였다 2). 치과의사는진료중어린이의행동관리에서어려움을겪는경우가많으며주로치과에서받는스트레스가비협조적인행동의원인으로생각된다 3). 심한치과적공포와불안으로치과적행동조절에문제를일으키는환자의경우, 진정법과같은약물적행동조절방법이요구될수있다 4). 진정법이국내에소개되고본격적으로시행된지도 30여년이지났고, 2004년전문의제도가시행된후로 10년이넘는시간이흘렀다. 더욱이 2014년부터는전문의표방이가능하도록제도가바뀌었다 1). 최근대한소아치과학회산하진정법위원회에서진정법을사용하는소아치과회원 215명에게 2014년 2월메일로설문을보내어응답한 111명의자료를분석한결과지난 20년동안진정법의시행이많아지고있었다. 그러나 치과진정법진료지침 에대해 78% 가인식하고있으나활용정도에대해서는꽤참조하는편이라는응답이 17% 밖에되지않아진료지침의활용정도는매우부족한상황이다 5). 한편근대이후과학이발달하면서의학도과학적근거에의해발달해왔다. 그러나임상진료가지금까지항상과학적근거에의해이루어졌다고보기는어렵다. 의료인이대학을졸업하고국가시험에합격하여면허를취득한후에는실제로충분한보수교육이이루어지지않는다. 의학의발달이느리게진행되던과거에는과거에습득한지식과계속쌓여가는경험에의지하여환자를진료하는것이가능하였다. 그러나지금은지식이폭발적으로증가하고있으며교과서는최신의정보원이될수없고수많은저널들에발표되는기사들을개인이모두읽어보고비교평가하여정확한정보를얻기는매우힘든실정이다. 최근에인터넷을비롯한정보기술의발달은방대한의학정보의수집과체계적검토를가능하게하였다. 이러한변화와필요성에따라최근에부상한새로운개념이근거중심의학 (Evidence-Based Medicine) 이다 6). 근거중심의학은보건의료분야의의사결정을과학적인근거에기초하여하는것으로서, 의학이갖추어야할조건이고의료인이지녀야하는지식과기술이다. 나아가보건정책등의료분야전반에서그중요성이인식되고있다. 근거중심의학이라는용어를처음사용한것은 1992년에캐나다 McMaster 대학의 Guyatt 연구진이며 7), 근거중심의학관련문헌수는 1992년에한개의문헌에서시작하여 1998년에약 1,000개로증가하였고지금은기하급수적으로증가하고있다. 근거중심의학의실행에있어핵심적인내용인체계적고찰 (systemic review) 은우리나라에서도활동이늘고는있으나아직활성화되기에는많은과제가놓여있다. 체계적고찰은명시적인방법을통해과학적인근거를통합하고제시하여신뢰할수있는객관적근거를제공하는근거중심의학의핵심적인영역의하나이다. 특정한주제에대하여문헌을객관적으로평가하고엄격한방법론을사용하여종합된추정치등을제시하는것이다 8). 소아치과에서협조가되지않는어린이의치과치료시사용하는진정법은환자안전을최우선으로고려하여야하며, 이를위해 evidence-based 진료가필요하다 5). 근거중심의학의부상 에따라치의학계에도근거중심치의학 (Evidence-Based Dentistry) 에대한관심이점차증가하고있으나아직이에대한국내의관심과발전은더딘실정이다. 국내소아치과학분야에서도대한소아치과학회의학술대회나대한소아치과학회지기사에서근거중심소아치과학 (Evidence-Based Pediatric Dentistry) 에관한발표나논의가희소하였으며 6), 한국의치과진정법에대한근거중심의체계적인연구는거의이루어지지않고있다. 이연구의목적은체계적인문헌고찰법을이용하여지금까지국내에보고된소아치과진정 ( 요 ) 법을검토하고, 향후국내의근거중심소아치과진정법의발전방향을모색하는한편근거중심의치과진정법진료지침개발의기초자료로활용하기위한것이다. Ⅱ. 연구대상및방법본연구는 한국보건의료연구원의체계적인문헌고찰지침 9) 을참고하여국내 5개데이터베이스 1) Core 검색데이터베이스- KM base, KISS 2) 학술정보및포털 -국회도서관, DBpia, RISS를검색하였다. 치과진정법 및 치과진정요법 으로검색어를제안한총 470 편의논문중문헌선택과정의흐름도를따라중복제거하고남은 263개의논문중회색문헌및배제기준을제외하고원문이제공되는문헌을모두취합한총 20개문헌을분석대상으로삼았다. 1. 연구대상본연구의분석대상은국내주요문헌데이터베이스 5개를이용하여 치과진정법 을주제로한논문 470편이다. 관련문헌검색은국내데이터베이스 1) Core 검색데이터베이스- KM base( 한국의학논문데이터베이스, http://kmbase.medric. or.kr), KISS( 학술데이터베이스검색, http://kiss.kstudy. com), 2) 학술정보및포털 - 국회도서관 (http://www. nanet.go.kr), DBpia(http://www.dbpia.co.kr), RISS( 학술연구정보서비스, http://www.riss4u.net/index.jsp) 를기반으로검색하였다. 검색시기는각데이터베이스의자료제공일및저널발행일로부터 2015년 8월까지발간된논문을대상으로하였다. 검색어는국문검색어 치과진정법 및 치과진정요법 으로제한하였다. 조사대상의선택과배제요인은 Table 1과같다. Table 1. Eligibility and ineligibility criteria for the study Eligibility criteria Ineligibility criteria Failure to secure the full text of the paper Child and adolescent Adult age group only age group Guideline and survey Conscious sedation Deep sedation 332
2. 연구방법 3. 문헌의질평가 국내문헌데이터베이스 5개에서 치과진정 ( 요 ) 법 이라는검색어로논문을검색한후, 분석문헌을선택하기위해원문이제공되는문헌을모두취합하여각데이터베이스별로자료를받아엑셀로저장하였다. 검색된 치과진정 ( 요 ) 법 과관련이없는논문, 검색어가논문제목에포함되어있으나원문이제공되지않는학술대회초록집, 치과진정법이란단어가제목에각각분리되어의미가달라지거나모호해진논문, 저자요청등의이유로서지정보만제공되고원문은제공되지않는논문, 회색문헌 ( 석, 박사학위논문, 연구보고서, 포스터및구연자료, 편집인의글 ) 을배제하였다 (Fig. 1). 1차적으로검색된문헌은 KMbase 4편 /0편, KISS 20편 /0 편, 국회도서관 24편, DBpia 0편 /0편, RISS 252편 /180편으로총 470편이었다. 이중중복여부를확인하고논문의제목과초록을수기로확인후자료의원문제공여부확인을거쳐남은문헌수는 86편이었으며, 위의배제기준을적용하여선정한총 20편의논문을최종연구자료로선택하였는데이는 Table 2와같다. GRADE(Grading of Recommendations Assessment Development and Evaluation) System(GRADE working group, 2004, http://www.gradeworkinggroup.org) 10) 을이용하여문헌의질을평가하였다. 문헌의질은높음, 보통, 낮음, 매우낮음으로분류되었다. Ⅲ. 연구성적주연구대상논문들의질평가결과무작위대조군연구 (RCTs) 와코호트 (COHORT) 연구는한편도존재하지않았다 (Table 3, 4). 1. 사용된약물과투여경로연구에사용된약물들을살펴보면, Chloral hydrate (20편중 15편, 75%), Hydroxyzine (20편중 14편 70%), Midazolam (20편중 11편, 55%) 이가장많았고 N2O-O2와 Fig. 1. The flow of the literature selection process. 333
Table 2. Description of selected studies No Article Title Sedative drugs Age (mg/kg, %) Method (month) Sample size 1 Kim YK, Park HS, Clinical study on the effect of chloral CH(50-50), Hy(25) PO, Rectum 36.6 20 Kim JS 1990 11) hydrate and hydroxyzinein sedating (12M, 8F) child patients for dental treatment. 2 Park HS, Kim YK 1990 12) Clinical report on the sedative effect CH(50-75) PO, Rectum 38 86 of chloral hydrate administered (42M, 44F) via rectum. 3 Kim YK, Kim JS 1995 13) Evaluation of the sedative effect of Mdz(0.2) IN 38 19 intranasal midazolam : a case report. (11M, 8F) 4 Eum JH, Kim S 1995 14) Sedation therapy through intranasal Mdz(0.2-0.5) IN 42 administration of midazolam. 5 Jung JH, Park KT 2001 15) Evaluation of success rate and CH(60), Hy(25) PO 30 71 temporary hypoxia in pediatric (40M, 31F) dental sedation using chloral hydrate and hydroxyzine. 6 Lee IC, Kim JS, The comparative study on the efficacy CH(70), Hy(1-3) PO 33 50 Kwoon SW 2001 16) of chloral hydrate and hydroxyzine (35M, 15F) of different doses in sedating young pediatric dental patients. 7 Choi NK, Jung BC, Effects of sedative drugs for CH(75), Hy(25), PO, IN 18-92 64 Yang KH 2002 17) management in children. Mdz(0.1), N 2O-O 2 (42M, 22F) 8 Hong SJ, Lee KH 2002 18) A study on the conscious sedative CH(50), Hy(25), PO 30 20 effect of chloral hydrate/hydroxyzine N 2O-O 2(30) (12M, 8F) with and without N 2O-O 2. 9 Park HD, Lee CS, Comparative evaluation of intranasal Mdz(0.2-0.5) PO, IN 38 28 Lee SH, et al. 2004 19) and oral midazolam. (15M, 13F) 10 Kim YH, Kim JY, A comparative study of chloral CH(60), Hy(25), PO 36 15 Park KT 2005 20) hydrate/hydroxyzine versus Mdz(1), Mep(1), (11M, 4F) midazolam/meperidine as oral N 2O-O 2(50) conscious sedative regimens. 11 Kim EY, Kim JS, The comparative study on the sedative Mdz(0.1/0.2), IM, IV 55 16 Yoo SH 2005 21) effect of different intravenous midazolam N 2O-O 2(30-50) dosages for pediatric dental patients. 12 Rho SC, Kim YJ, A comparison of the sedative effect CH(50/70), Hy(2), PO 39 62 Jang KT, et al. 2005 22) on chloral hydrate dosage in the N 2O-O 2(50) sedation of the pediatric dental patients. 13 Park KT, Kim JY, The influence of obesity on pediatric CH(60), Hy(25) PO 31 22 Park SD 2006 23) conscious sedation. 14 Lee YE, Park MK, Sedation evaluation using bis index CH(60), Hy(1), Mdz(0.1), PO, SM 40 27 Kim SY, et al. 2007 24) assessment with and without the N 2O-O 2(50) (17M, 10F) added submucosal midazolam. 15 Kim KH, Kim JS, A study on the effects of sedation CH(70), Hy(2), PO, IN 31 94 Kim SO 2007 25) and related variables for pediatric Mdz(0.1-0.2), (46M, 48F) dental patients. N 2O-O 2(30-50) 16 Kim YH, Jung SH, Comparison of Behavioral Response CH(50), Hy(1), PO, IN, SM 24-72 33 Baek KW 2008 26) between Intranasal and Submucosal Mdz(0.1), N 2O-O 2(50) (20M, 13F) Midazolam Administration. 17 Koo JE, Baek KW 2009 27) Postsedation events in pediatric CH(35-65), Hy(1), PO, SM 40 335 patients sedated for dental treatment. Mdz(0.1-0.3), N 2O-O 2(50) (182M, 153F) 18 Kim HJ, Baek KW, Effects of children s tonsil size on CH(50), Hy(1), PO, SM 19-66 35 Mah YJ, et al. 2010 28) the behavior during pediatric dental N 2O-O 2(50), Mdz(0.1-0.3) (22M, 13F) sedation. 19 Maeng YJ, Oh SH 2011 29) An effect of sleeping hours prior to CH(70), Hy(1), N 2O-O 2(50) PO 24-52 37 procedure on chloral hydrate sedation (16M, 21F) for pediatric dental patient. 20 Jang SY, Kim JY, Effect of supplementary intranasal PO, IN 37 88 Park KT 2012 30) midazolam on oral sedation of children. CH(50-60), Hy(25), (44M, 44F) Mdz(0.1-0.2), N 2O-O 2(50) M: male, F: female, CH: chloral hydrate, Hy: hydroxyzine, Mdz: midazolam, Mep: meperidine, PO: peroral, IN: intranasal, IM: intramuscular injection, IV: intravenous injection, SM: submucosal injection 334
Table 3. Summary of cross sectional studies used in the GRADE assessment Cross sectional study Drug and route Evidence Kim YK, Park HS, Kim JS 1990 CH, Hy, PO, In comparison of oral administration of chloral hydrate 50 mg/kg, oral administration Rectal of chloral hydrate 50 mg/kg with hydroxyzine 25 mg and intrarectal administration of chloral hydrate 50 mg/kg, each success rate reported 55%, 75% and 35%. Lee IC, Kim JS, Kwoon SW 2001 CH, Hy, PO In case of administration of chloral hydrate 70 mg/kg only and with hydroxyzine 1 mg, 2 mg, 3 mg/kg, objective behavior pattern was evaluated by using Automated counting system(acs) and subjective treatment effect was evaluated. As combination of the results, administration of chloral hydrate 70 mg/kg with hydroxyzine 2 mg/kg was effective. Park HD, Lee CS, Lee SH, et al. 2004 Mdz, PO, IN In comparison of intranasal administration of midazolam 0.2 mg/kg and intraoral administration of midazolam 0.5 mg/kg, intraoral administration has similar sedative effect as intranasal administration and tendency more acceptable for patients than intranasal administration. Kim YH, Kim JY, Park KT 2005 CH, Hy, Mdz, In comparison of intraoral administration of chloral hydrate 60 mg/kg with Mep, PO hydroxyzine 25 mg and midazolam 1 mg/kg with meperidine 1 mg/kg in same patient at intervals of 1 month, the former was more effective in sedation than the latter. Kim EY, Kim JS, Yoo SH 2005 Mdz, N 2O-O 2, In comparison of intramuscular injection of midazolam 0.3 mg/kg(maximum 5 mg), IM, Inhalation, midazolam 0.1 mg/kg after application of N 2O-O 2 and intravascular administration of IV midazolam 0.2 mg/kg, clinical success rate was higher in administration of increased doses but there were no significant differences. CH: chloral hydrate, Hy: hydroxyzine, Mdz: midazolam, Mep: meperidine, PO: peroral, IN: intranasal, IM: intramuscular injection, IV: intravenous injection Table 4. Summary of case controled studies used in the GRADE assessment Cross sectional study Drug and route Evidence Hong SJ, Lee KH 2002 CH, Hy, In cases of administration of chloral hydrate 50 mg/kg with hydroxyzine 25 mg and N 2O-O 2, PO, chloral hydrate 50 mg/kg with hydroxyzine 25 mg, 30% N 2O and 70% O 2, 63.3% Inhalation and 93.3% of each group reported satisfactory sedative effect. Rho SC, Kim YJ, Jang KT, et al. 2005 CH, Hy, N 2O-O 2, In cases of administration of chloral hydrate 50 mg/kg, chloral hydrate 70 mg/kg with PO, Inhalation hydroxyzine 2 mg/kg and chloral hydrate 70 mg/kg with hydroxyzine 2 mg/kg and 50% N 2O-O 2, increased doses group were more effective. Lee YE, Park MK, Kim SY, et al. 2007 CH, Hy, N 2O-O 2, In comparison of application of chloral hydrate 60 mg/kg, hydroxyzine 1 mg/kg, Mdz, PO, N 2O-O 2(50%) and combination with submucosal administration of midazolam Inhalation, SM 0.1 mg/kg, additional submucosal administration of midazolam made deeper sedative effect within a range of safety. Kim YH, Jung SH, Baek KW 2008 CH, Hy, N 2O-O 2, In comparison of application of chloral hydrate 50 mg/kg with hydroxyzine 1 mg/kg Mdz, PO, and additional intranasal administration of midazolam 0.2 mg/kg to N 2O-O 2(50%), Inhalation, IN, SM there were no differences. CH: chloral hydrate, Hy: hydroxyzine, Mdz: midazolam, Mep: meperidine, PO: peroral, IN: intranasal, IM: intramuscular injection, IV: intravenous injection, SM: submucosal injection Meperidine 등이있었다. 투여경로는경구와직장내 (Chloral hydrate), 비강내, 점막하, 근육내, 정맥내 (Midazolam) 등이었다. 2. 사용된약물의용량과연령및표본크기 1) Chloral hydrate과 Hydroxyzine 박과김 11) 은구강내로 Chloral hydrate 50 mg/kg 단독, Chloral hydrate 50 mg/kg과 Hydroxyzine 25 mg 병용및 Chloral hydrate 50 mg/kg을직장내투여를비교한결과 55%, 75%, 35% 의성공률 (Lunt의방법 31) ) 을보고했다. 정과박 15) 은 Chloral hydrate 60 mg/kg와 Hydroxyzine 25 mg을투여했을때 69.6% 성공률 (Houpt의방법 32) 을변형함 ) 을보였고 42.2% 에서일시적저산소증을보였다고하였다. 이, 김과권 16) 은 Chloral hydrate 70 mg/kg 단독과추가로 Hydroxyzine을 kg 당 1 mg, 2 mg, 3 mg을투여시 Automated counting system (ACS) 를이용하여객관적행동양상평가 (OSUBRS, ohio state university behavior rating scale) 와 335
주관적치료효과평가결과를조합하여 Chloral hydrate 70 mg/kg와 Hydroxyzine 2 mg/kg이효과적이라고하였다. 홍과이 18) 는 Chloral hydrate 50 mg/kg와 Hydroxyzine 25 mg만을투여했을때 63.3% 가, Chloral hydrate 50 mg/kg와 Hydroxyzine 25 mg에 30% N2O 와 70% O2를혼합사용시 93.3% 에서만족할만한진정효과를얻을수있다고하였다.( 평가방법은 Houpt의방법 32) ) N2O-O2를병용한경우에서 Chloral hydrate와 Hydroxyzine 성공률이높은이유는 1971년 Hogue 등 33) 의주장과같이첫째, N2O-O2의사용이경구투여된진정제의약효를높이는데기여하였으며, 둘째, N2O-O2의적용이구강점막의감각이둔화되어개구기의장착또는마취시의자입자극등에대한동통의역치가높아진것으로판단된다고하였다. 노등 22) 은 Chloral hydrate 50 mg/kg과 Chloral hydrate 70 mg/kg을 Hydroxyzine 2 mg/kg와 50% N2O-O2를혼합사용시고용량에서더효과가높았다고하였다. 최, 정과양 17) 은 Chloral hydrate 75 mg/kg와 Hydroxyzine 25 mg만을투여했을때와, Chloral hydrate 75 mg/kg와 Hydroxyzine 25 mg에 30% N2O 와 70% O2를혼합사용시 Midazolam 0.1 mg/kg 근육주사 (IM) 와 30% N2O와 70% O2를혼합사용시 Chloral hydrate 75 mg/kg와 Hydroxyzine 25 mg에 Midazolan 0.1 mg/kg 근육주사 (IM) 와 30% N2O 와 70% O2를모두사용시 (Houpt의방법 32) ) 비교한결과 Chloral hydrate와 Hydroxyzine을복합투여한진정방법이 Midazolam( 근주 IM) 과 N2O-O2를혼합사용보다더효과적인진정효과를얻을수있었다고하였다. 2) Midazolam 김과이 3) 는 Midazolam 0.2 mg/kg을비강내투여시 69% 의성공률 (Houpt의방법 32) ) 을나타냈는데 36개월미만보다이상의연령에서더높은 (75%) 성공률을보였다고하였다. 박등 19) 은 Midazolam 0.2 mg/kg을비강내투여시와 Midazolam 0.5 mg/kg을구강내투여시 (Houpt의방법 32) ) 효과를비교한결과경구투여는경비투여와유사한적절한진정효과를가지면서환자에게더잘받아들여지는투여방법으로생각된다고하였다. 김, 김과유 21) 는 Midazolam 0.3 mg/kg( 최대 5 mg) 을근육내투여와 N2O-O2(30-50%) 후 Midazolam 0.1 mg/kg과 0.2 mg/kg을정맥내투여시효과를비교한결과, 용량이증가되었을때임상적성공률 (Automated counting system (ACS) 를이용하여객관적행동양상평가 (OSUBRS, ohio state university behavior rating scale) 와주관적치료효과평가결과를조합 ) 이높았으나통계적으로유의하지는않았다고하였다. 3) 기타김, 김과박 20) 은 Chloral hydrate 60 mg/kg와 Hydroxyzine 25 mg과 Midazolam 1 mg/kg과 Meperidine 1 mg/kg을 (Houpt의방법 32) ) 같은어린이에서한달간격으로시행후효과를비교한결과 Chloral hydrate와 Hydroxyzine을경구투여한경우가 Midazolam과 Meperidine을경구투여한경우보다우수한진정효과를보인다고하였다. 이등 24) 은 Chloral hydrate 60 mg/kg, Hydroxyzine 1 mg/kg과 N2O-O2(50%) 군과위세가지에추가로 Midazolam 0.1 mg/kg 점막하주사를병용한군의비교결과점막하주사를이용한 Midazolam의추가투여는안전성을크게침해하지않는범위내에서진정깊이를깊게한다고하였다. 김, 정과백 16) 은 Chloral hydrate 50 mg/kg, Hydroxyzine 1 mg/kg과 N2O-O2(50%) 에추가로 Midazolam 0.2 mg/kg 을비강내투여와점막하주사투여한군의비교결과두가지경로에서차이가없다고하였다. Ⅳ. 고찰이번국내체계적문헌고찰결과, 치과진정 ( 요 ) 법에사용하고있는여러약물의용량과병용및투여방법에따른성공률의차이와효과에대한다양한비교연구들이진행된것으로조사되었다. 치과진정법시주로사용하고있는 Chloral hydrate (CH), Hydorxyzine(Hy), Midazolam(Mdz), N2O-O2의용량과투여경로는미국소아치과학회및대한소아치과학회의기준을따르고있었다. 미국소아치과학회에서실시한조사에의하면, 미국소아치과의사들의 70-80% 가경구투여에의한진정요법을, 약 85% 는 N2O-O2에의한흡입진정법을사용하고있는것으로나타났다 34). 국내연구에서는 1999년최와심등 35) 에의하면흡입, 경구, 근육내, 비강내, 정맥내, 직장내순으로약물을투여한다고하였으며, 2004년안등 36) 에의하면경구, 흡입, 비강내, 근육내, 정맥내, 직장내순으로약물을투여하며 Chloral hydrate(ch), Hydorxyzine(Hy) 과 N2O-O2를병행하여사용하고있는경우가 60%, Chloral hydrate(ch), Hydorxyzine(Hy) 만사용하는경우가 34% 라고하였다. 2014년진행된설문조사결과, Chloral hydrate(ch) 50-70 mg/kg, Hydorxyzine(Hy) 1-2 mg/kg, Midazolam 근주 (Mdz, IM) 0.1-0.2 mg/kg가한국소아치과의사들이선호하는치과진정법약물의용량이며, 치과진정법시선호하는약물의조합은 CH+Hy+N2O-O2(67.6%), CH+Hy+Mdz 점막하주사 (SM)+N2O-O2(29.7%), Mdz IM+ N2O-O2(23.4%) 등으로 3가지이상의약제를함께사용하고있었다. 48% 는약제의추가투여를하고있으며주로 Midazolam을사용하여점막하주사를하고있었다 5). 그러나, 진정법의부작용은 3가지이상의약물을조합하여사용하는경우와관련이깊다 37,38). 2014년국내조사결과, 치과진정법시부작용을경험한응답자는 87.5% 로 5), 10년전진행된안등 36) 의조사결과 (41%) 와비교시 2배이상의증가를보였다. 부작용은주로오심과구토, 과흥분, 호흡저하및호흡곤란, 비틀거림등으로이전연구들과유사하였다 39). 그러므로최근조사결과를비춰볼때, 국내치 336
과진정법시 2가지이상의약제들을병용하는경우의증가와그에따른부작용발생이증가되고있으나, 사용되는약제들의안전한용량에대한정확한진료지침이없어이에대한연구및진료지침의제정이필요하다. Ⅴ. 결론이번체계적문헌고찰은한국소아치과영역에서지난 25년간시행된치과진정법에관한일관된근거 (evidence) 를확인하기위하여 GRADE 과정에정의된객관적인기준에기초하여진행된결과, 전체적인근거는보통 (moderate) 의질로평가되었다. 그러나특히약물의추가투여부분에대해서는매우낮은 (very low) 의질로평가되었다. 그러므로향후약물의추가투여부분에대해보다체계적으로잘고안된임상실험이필요하다. References 1. Kim JB, Yoo SH, Kim JS : The Qualification of Dentist for Sedation : BLS and ACLS. J Korean Acad Pediatr Dent, 42:80-86, 2015. 2. Klingberg G, Broberg AS : Dental fear/anxiety and dental behavior management problems in children and adolescents : a review of prevalence and concomitant psychological factors. Int J Pediatr Dent, 17:391-406, 2007. 3. Oh JE, Kim JS, Yoo SH : The Assessment of Stress of Children under Dental Procedures Using Wrist Watch Type Heart Rate Monitoring Devices - Using New Device for Stress Assessment in Children During Restorative Dental Treatment. J Korean Acad Pediatr Dent, 42:119-125, 2015. 4. Chi SI, Kim JS : Effects of Midazolam with Sevoflurane Insufflation Sedation on Concomitant Administration in Pediatric Patients : A Preliminary Study. J Korean Acad Pediatr Dent, 41:283-291, 2014. 5. Yang YM, Shin TJ, Yoo SH, et al. : Survey of Sedation Practices by Pediatric Dentists. J Korean Acad Pediatr Dent, 41:257-265, 2014. 6. Lee KH : Evidence-based pediatric dentistry : concepts and applications. J Korean Acad Pediatr Dent, 33:269-80, 2006. 7. Evidence-Based Medicine Working Group : Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA, 268:2420-2425, 1992. 8. Korean academy of medical science. Assessment service. Available from URL: http://kams.or.kr/ (Accessed on October 22, 2015) 9. National Evidence-based healthcare Collaborating Agency : NECA s guidance for undertaking systematic reviews and meta-analyses for intervention. NECA, Seoul, 2011. Assessment service. Available from URL: http://neca.re.kr/eng/ (Accessed on October 22, 2015) 10. Glasziou P, Vandenbroucke J, Chalmers I : Assessing the quality of research. BMJ, 328:39-41, 2004. 11. Park HS, Kim YK : Clinical study on the effect of chloral hydrate and hydroxyzine in sedating child patients for dental treatment. J Korean Acad Pediatr Dent, 17:1-14, 1990. 12. Kim YK, Park HS, Kim JS : Clinical report on the sedative effect of chloral hydrate administered via rectum. J Korean Acad Pediatr Dent, 17:197-202, 1990. 13. Kim YK, Kim JS : Evaluation of the sedative effect of intranasal midazolam : a case report. J Korean Acad Pediatr Dent, 22:393-400, 1995. 14. Eum JH, Kim S : Sedation therapy through intranasal administration of midazolam. J Korean Acad Pediatr Dent, 22:481-485, 1995. 15. Jung JH, Park KT : Evaluation of success rate and temporary hypoxia in pediatric dental sedation using chloral hydrate and hydroxyzine. J Korean Acad Pediatr Dent, 28:337-344, 2001. 16. Lee IC, Kim JS, Kwoon SW : The comparative study on the efficacy of chloral hydrate and hydroxyzine of different doses in sedating young pediatric dental patients. J Korean Acad Pediatr Dent, 28:430-440, 2001. 17. Choi NK, Jung BC, Yang KH : Effects of sedative drugs for management in children. J Korean Acad Pediatr Dent, 29:304-312, 2002. 18. Hong SJ, Lee KH : A study on the conscious sedative effect of chloral hydrate/hydroxyzine with and without N2O-O2. J Korean Acad Pediatr Dent, 29: 489-497, 2002. 19. Park HD, Lee CS, Lee SH, et al. : Comparative evaluation of intranasal and oral midazolam. J Korean Acad Pediatr Dent, 31:431-438, 2004. 20. Kim YH, Kim JY, Park KT : A comparative study of chloral hydrate/hydroxyzine versus midazolam/ meperidine as oral conscious sedative regimens. J Korean Acad Pediatr Dent, 32:262-269, 2005. 337
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국문초록 소아치과환자에대한진정법의체계적분석방법고찰 안소연 1 이제우 1 김승오 2 김종빈 3 1 원광대학교치과대학소아치과학교실단국대학교치과대학 2 치과마취학교실, 3 소아치과학교실 소아치과에서협조가되지않는어린이의치과치료시사용하는진정법은환자안전을최우선으로고려하여야하며, 의료사고예방을위한 evidence-based 진료가필요하다. 근거중심의학의부상에따라치의학계에도근거중심치의학 (Evidence- Based Dentistry) 에대한관심이점차증가하고있으나한국의진정법에대한근거중심의체계적인연구는거의이루어지지않고있다. 이연구의목적은체계적인문헌고찰법을이용하여지금까지국내에보고된소아치과진정 ( 요 ) 법을검토하고, 향후국내의근거중심소아치과진정법의발전방향을모색하는것이다. 본연구는 한국보건의료연구원의체계적인문헌고찰지침 을참고하여국내 5개데이터베이스 1) Core 검색데이터베이스- KM base, KISS 2) 학술정보및포털 -국회도서관, DBpia, RISS를검색하였다. 치과진정법 및 치과진정요법 으로검색어를제안한총 470편의논문중문헌선택과정의흐름도를따라중복제거하고남은 31개의논문중원문이제공되는문헌을모두취합한총 20개문헌을분석대상으로삼았다. 이번체계적문헌고찰은한국소아치과영역에서지난 25년간시행된치과진정법에관한일관된근거 (evidence) 를확인하기위하여 GRADE 과정에정의된객관적인기준에기초하여진행된결과, 전체적인근거는보통 (moderate) 의질로평가되었다. 그러나, 특히약물의추가투여부분에대해서는매우낮은 (very low) 의질로평가되었다. 그러므로향후안전한약물의사용부분에대해보다체계적으로잘고안된임상실험이필요하다. 주요어 : 근거중심 ( 치 ) 의학, 체계적문헌고찰, 치과진정법, 한국, 어린이 339