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1 Anesth Pain Med 2016; 11: 임상연구 pissn ㆍ eissn 비마취과의사에의해시행된 chloral hydrate 중심의소아진정평가 고려대학교의과대학구로병원마취통증의학교실 김영성ㆍ임병건ㆍ강성욱ㆍ이소현ㆍ이원준ㆍ이일옥 Assessment of chloral hydrate-centered pediatric sedation performed by non-anesthesiologists Young Sung Kim, Byung Gun Lim, Sung Wook Kang, So Hyun Lee, Wonjoon Lee, and Il Ok Lee Department of Anesthesiology and Pain Medicine, Guro Hospital, Korea University College of Medicine, Seoul, Korea Background: We aimed to evaluate the efficacy and safety of chloral hydrate-based pediatric sedation conducted by nonanesthesiologists. Methods: The design and setting of this study was a single-center retrospective study performed at a tertiary university hospital between July 2012 and May A total of 519 children were enrolled in this study. We investigated the sedation medication, age of patients and type of diagnostic tests or procedures and evaluated the success rate of sedation, sedation/recovery profiles and adverse events. Results: Most patients underwent moderate sedation for diagnostic tests. The most commonly used sedative drug was chloral hydrate, which was solely used for 482 patients. A combination of chloral hydrate/midazolam was used for 24 patients and midazolam only was used for 13 patients. Use of chloral hydrate resulted in a sedation success rate of 65.5% after the initial dose and a success rate of 95.2% with additional doses. The sedation failure rate in children > 6 years was significantly higher than that in children under 6 years. In all patients, the overall onset time and recovery time were too slow and long, respectively, and there was no critical complication. Received: May 17, Revised: June 24, Accepted: July 7, Corresponding author: Byung Gun Lim, M.D., Ph.D., Department of Anesthesiology and Pain Medicine, Guro Hospital, Korea University College of Medicine, 148, Gurodong-ro, Guro-gu, Seoul 08308, Korea. Tel: , Fax: , bglim9205@korea.ac.kr This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Conclusions: This study demonstrated that chloral hydrate-based pediatric sedation conducted by non-anesthesiologists was mostly moderate, with a high success rate and a low complication rate. However, the overall onset time and recovery time were too slow and long, respectively. Especially, alternative sedation regimens are required in children > 6 years considering the slower onset time and higher failure rate of sedation. (Anesth Pain Med 2016; 11: ) Key Words: Child, Chloral hydrate, Midazolam, Non-anesthesiologists, Sedation. 서 소아마취과의사의활동영역은수술실이외에도소아환자가컴퓨터단층촬영이나자기공명영상, 혹은통증을유발하는검사및치료를받는모든장소를포함하고있으며이는소아환자의안전과예후를위해중요하다 [1]. 하지만현실적으로수술실밖의소아진정치료 (pediatric procedural sedation) 가비마취과의사에의해이루어지는경우가많으며 [1-5], 연령별로어떠한약제및방법을사용하여소아진정을시행하는것이이상적인지에대한의견일치가부족하다. 이상적인소아진정약제의조건으로는투약방법이쉽고, 작용발현시간이빠르며, 약물효과의예측이용이하고, 회복이빠르며, 급성독성및축적작용이없고, 대사산물의약리작용이없을것, 경제적인비용등을들수있지만이를모두만족하기는쉽지않다. Chloral hydrate는경구투여할수있으며약물의안전성이높고부작용이적기때문에단기간소아를진정시키기에효과적인비마약성진정 수면약제로서오랫동안사용되어왔지만 [6,7], 작용발현시간을예측하기어렵고작용시간이비교적긴단점을가지고있다 [7]. 과투여시대사산물 (trichloroethanol and trichloroacetic acid) 의축적, 중추신경계억제등의심각한부작용이발생할수있고 [8-10], 일반적치료용량에서도무호흡, 산소포화도의감소, 구토, 저혈압, 원치않는진정의연장등의발생이보고되었다 [7,11]. 또한, 검사시간이길어지는경우나적절한용량을투여하지못하는경우필요로하는진정에실패하는경우가발생하는데 론 366

2 김영성외 5 인 :Pediatric sedation by non-anesthetists 367 여러연구에의하면 chloral hydrate 단독투여에의한진정실패율은 0 33% 까지매우다양하게보고되어왔다 [4,6,12,13]. 이러한 chloral hydrate의여러단점에도불구하고, 국내비마취과의사가시행하는소아진정에서여전히 chloral hydrate가주요약제로써사용되고있고본원또한마찬가지실정이다. 이에본연구는비마취과의료인이시행한 chloral hydrate 중심의소아진정을후향적으로분석하여진정성공률, 진정및회복시간, 약제부작용 (adverse events) 의유무를평가하여그효용성및안전성을파악함으로써향후국내소아진정의방향제시및한국형소아진정가이드라인의구축에도움을주고자하였다. 대상및방법본연구는 2012년 7월부터 2013년 5월까지본원소아진정실에서소아진정운영지침 (Appendix 1) 에따라비마취과의료인에의해진정이수행된모든소아환자를대상으로하였고, 본원기관연구윤리심의위원회의승인 ( 환자및보호자의동의취득면제 ) 을받은후진행되었다. 본연구에필요한자료 (data) 취득은환자의전자의무기록 (electronic Medical Record; 진정 회복기록지 ) 의후향적 (retrospective) 분석을통해수행되었다. 미국마취과학회신체등급분류 (ASA class) III 이상, 두통, 기면, 구토등뇌압상승의증상이있었던경우, 의식의저하가있었던환아들은본연구에서제외하였다. 본연구에포함된소아진정은모두소아진정실을통해진행되었는데검사및시술종류로는뇌파 (EEG), 각종유발전위 (evoked potential), 심장초음파 (2-D echo), 핵의학검사, 자기공명영상 (MRI), 컴퓨터단층촬영 (CT) 등이포함되었고주로소아청소년과를비롯한여러임상과의환아들이포함되었다 (Tables 1A 1C). 해당임상과의주치의 ( 진정진료권자 ) 는환아및보호자에게진정수행전진정과관련한제반사항에관해설명 한후진정동의서를받았고, 진정전기록지작성을통해환아평가및진정계획을수립하였다. 진정코디네이터 ( 간호사 ) 와함께진정의모든과정에서환아를지속적으로모니터링하여의식및환기, 혈역학상태를평가하였고이를투약기록과함께진정 회복기록지에작성하였다. 소아진정수행시환아감시및평가는다음과같이진행되었다. 진정시작하기직전, 진정제투여후부터 5분마다, 회복시작시점, 회복실퇴실시각각맥박, 산소포화도, 진정점수 (Appendix 2; Ramsay sedation scale; sedation score) 를기록한다. 진정후환아의퇴실결정은자격을갖춘의료진에의해회복점수 (Appendix 3) 를측정하여평가한후아래기준에의해결정되었다. 1) 어떤항목이라도 0 점이있는경우는퇴실할수없다. 2) 길항제를투여한경우에는최소 1시간이상모니터링한후퇴실할수있다. 3) 회복점수가 9점이상일경우는담당간호사가퇴실시킬수있다. Table 1A. Overall Patient Characteristics (n = 519) Age Overall age (yr) 3.8 ± (9.6) > (12.5) > (58.4) > (12.9) > (6.6) Sex Male 304 (58.6) Female 215 (41.4) Sedation medication Chloral hydrate only 482 (92.9) Chloral hydrate + Midazolam 24 (4.6) Midazolam only 13 (2.5) Values are mean ± SD or numbers of patients (%). Table 1B. The Distribution of Clinical Departments by Age of Patients Underwent Sedation Overall 0.5 > > 1 6 > 6 12 > 12 (yr) PED ENT CA OS RM PS GU Others Values are numbers of patients. PED: pediatrics, ENT: ear, nose & throat, CA: cardiology, OS: orthopedic surgery, RM: rehabilitation medicine, PS: plastic surgery, GU: genitourinary. Others include general surgery, neurosurgery, ophthalmology and dermatology.

3 368 Anesth Pain Med Vol. 11, No. 4, 2016 Table 1C. The Distribution of Diagnostic Tests or Minor Procedures by Age of Patients Underwent Sedation Overall 0.5 > > 1 6 > 6 12 > 12 (yr) EEG and EP Echocardiography Nuclear tests Magnetic resonance imaging Computed tomography Others Values are numbers of patients. EEG: electroencephalogram, EP: evoked potential. Nuclear tests include renal scan (99mTc-DMSA), kidney SPECT (single photon emission computed tomography) and diuretic renal scan. Others included other non-invasive tests such as an ultrasonography or minor procedures. 4) 회복점수가 9점미만이거나환자상태가불안정할경우해당임상과주치의의결정에의해퇴실한다. 진정약제선정은환아의주치의의재량하에이루어졌으며, 약제용량은 chloral hydrate는환아체중 kg당 50 mg ( 경구투여 ), midazolam은환아체중 kg당 0.1 mg ( 정주투여 ) 을초회용량으로설정하였다 [3,7]. 진정을위한약제투여직전부터모든환아들에서 Ramsay sedation scale (Appendix 2) 을이용하여진정점수를평가하였다. 초회용량투여 15 20분경과후에도진정점수가 4점미만인경우 25 mg/kg의 chloral hydrate 혹은 0.05 mg/kg의 midazolam을최대 2회까지추가투여하였으며추가용량으로도진정의깊이가부족하여검사및시술의완료가불가능한경우진정을중단하고재예약을하거나마취통증의학과에의뢰하였는데이를진정실패로정의하였다. 환아가적절히진정되는데걸리는시간 ( 진정발현시간 ) 은약물투여후진정점수 4점에도달하는데걸린시간 ( 중등도진정수준 ) 으로정하였으며회복시간은검사및시술종료후퇴실까지의시간으로정하였다. 회복시간이한시간이상일경우회복지연으로평가, 기록하였다. 약물투여후퇴실전까지발행하는모든약제부작용 ( 저산소증, 저혈압, 청색증, 구토, 무호흡, 기관지경련, 서맥등 ) 은진정 회복기록지에기록되었다. 진정에관련한모든자료는다음과같이정리하였다. 먼저투여한진정약제의종류에따라 3개의군 (chloral hydrate 단독투여군, chloral hydrate와 midazolam의병합투여군, midazolam 단독투여군 ) 으로나누었고, 환아연령대에따라세분화하여 (6개월이하, 6개월 1세이하, 1 6세이하, 6 12세이하, 12세초과 ) 진정에관련한주요평가변수 (main outcomes) 인진정시간, 회복시간, 검사시간, 진정실패율및약제부작용을정리한후, 이에대한비교분석을수행하였다. 환아의연령이진정성공여부에어떠한영향을미칠것인지, 즉진정실패를예측하기위한환아연령의절단값 (cut-off value) 을구하기위해민감도 (sensitivity) 와특이도 (specificity) 를이용한 receiver operating characteristic (ROC) curve를그리고 area under the curve (AUC) 값을구하였다. 통계분석은 SPSS version 20.0을이용하였다. 성별, 진정성공여부, 약제부작용유무의투여약제별비교는 chisquared test 혹은 Fisher s exact test를사용하였고연령별및투여약제별진정및회복시간비교에서 Kruskal-Wallis H 검정과 Mann-Whitney U 사후검정을사용하였다. 연령별로나눈군과진정성공여부의관계를알아보기위해서는 Fisher s exact test를사용하는것이이상적이나통계프로그램의한계상 Monte Carlo 방법을이용하였다 (5 3 columns). P 값이 0.05 미만인경우를통계적으로유의한것으로판정하였으며 Mann-Whitney U 사후검정에서는 Bonferroni보정값을고려하여분석하였다. 결과총 519명의환아가본연구에포함되었다. 투여한진정약제의종류에따라 chloral hydrate만단독사용한건이 482 건으로대부분을차지했고, chloral hydrate와 midazolam을병합한건이 24건, midazolam만사용한건이 13건이었다 (Table 1A). 진료과목은소아청소년과가대부분을차지했고, 검사항목은 EEG, evoked potential, 2-D echo, 핵의학검사, 자기공명영상, 컴퓨터단층촬영, 초음파, 가벼운시술등이포함되었다 (Tables 1B and 1C). Chloral hydrate와 midazolam을병용한진정에서는단 1건만초회투약으로두가지의약물을한번에사용하였고나머지 23건의경우 chloral hydrate 를먼저투약하고이후진정이안되어 midazolam을사용하였다. 즉 chloral hydrate의초회투여로진정이성공한건은총 331건으로그성공률은 65.5% (331 / [ ] 100) 였다. Chloral hydrate 추가사용으로진정이성공한건을포함하면 chloral hydrate의진정성공률은 95.2% ([ ] / ) 였다. 반면에 midazolam 초회투여시진정성공률은 23.1% (3 / ), midazolam을추가투여한경우를포함해도 midazolam의진정성공률은 46.2% (6 / ) 로 chloral hydrate와비교하여유의하게낮은결과를보였다 (P < 0.001; Table 2). Midazolam 투여후진정실패한

4 김영성외 5 인 :Pediatric sedation by non-anesthetists 369 Table 2. Sedation Success or Failure by Sedation Medication or Age Sedation success on initial medication Sedation success but require additional medication Sedation failure Sedation medication, n (%)* Chloral hydrate only 331 (68.7) 128 (26.6) 23 (4.8) Chloral hydrate + Midazolam 1 (4.2) 16 (66.7) 7 (29.2) Midazolam only 3 (23.1) 3 (23.1) 7 (53.8) Age (yr), n (%) (74.0) 13 (26.0) 0 (0.0) > (78.5) 12 (18.5) 2 (3.1) > (67.0) 87 (28.7) 13 (4.3) > (53.7) 19 (28.4) 12 (17.9) > 12 8 (23.5) 16 (47.1) 10 (29.4) Overall, n (%) 335 (64.55) 147 (28.32) 37 (7.13) *P < for sedation medication (Fisher s exact test). P < for age (Monte Carlo Method). Table 3. The Analysis of Characteristics of Sedation Failure Cases after Use of Midazolam with/without Chloral Hydrate Chloral hydrate + Midazolam 1 1, M/6 A normal patient. 1 2, M/10 A patient with epilepsy and mental retardation 1 3, F/11 A patient with epilepsy and pervasive developmental disorder 1 4, M/14 A patient with epilepsy and cerebral palsy 1 5, F/17 A patient with epilepsy, mental retardation and scoliosis 1 6, F/17 A patient with epilepsy 1 7, F/17 A patient with congenital hearing impairment, mental retardation and past history of sedation failure Midazolam 2 1, M/3 A possibility of pain induced by a fine needle aspiration 2 2, M/4 A possibility of pain induced by a fine needle aspiration 2 3, M/4 A patient with Kniest dysplasia, kyphoscoliosis, cleft palate, achondroplasia and past history of sedation failure 2 4, F/6 A possibility of pain induced by a fine needle aspiration 2 5, M/10 A possibility of pain induced by a biopsy 2 6, F/13 A patient with epilepsy, cerebral palsy, neuromuscular scoliosis and past history of sedation failure. 2 7, F/17 A patient with congenital hearing impairment, mental retardation and past history of sedation failure. The cases of 1 7 and 2 7 are sedation cases for a same patient. 환아들은뇌전증 (epilepsy) 등의신경학적질환을가진환아혹은비교적통증을수반한침습적검사의경우들이대부분이었으며세부사항은 Table 3에정리하였다. 환자의나이도진정실패율에유의한영향을주어 6세이후의환자에서 Fig. 1. The receiver operating characteristic (ROC) curve for predicting the failure or success of sedation. This curve shows the area under the curve (AUC) of and the cut-off value of age of 4.79 years (sensitivity 0.696, specificity 0.776) (P < 0.001). 6 세이하환자에비해진정실패율이유의하게높았다 (P < 0.001; Table 2). 환아의연령이진정실패를예측하는민감도와특이도를이용하여구한 ROC curve에서 AUC는 0.732, 절단값은 4.79세였다 (Fig. 1). Chloral hydrate와 midazolam을병용투여한군에서진정발현시간과회복시간모두 chloral hydrate나 midazolam만투여한군에비해유의하게길었고, midazolam만투여한군에서 chloral hydrate만투여한군보다빠른회복시간을보였다. 나이의경우 6개월 1세의환아가가장진정발현시간이짧았고이후로나이가많을수록진정발현시간이길어짐을알수있었다. 회복시간은연령별군간유의한차이를보이지않았다 (Table 4). 약제부작용은구역및구토 (nausea/vomiting) 가 15건으로가장많았으나전체환자의 3% 미만에불과하였으며심각

5 370 Anesth Pain Med Vol. 11, No. 4, 2016 Table 4. Sedation and Recovery Time Onset time Test or Procedure time Recovery time Total elapsed time Sedation medication Chloral hydrate only (n = 459) 22.3 ± ± ± ± 21.3 Chloral hydrate + Midazolam (n = 17) 43.2 ± 23.6* 34.7 ± ± 16.6* ± 36.9* Midazolam only (n = 6) 25.0 ± ± ± 6.9*, 76.7 ± 34.7 Age (yr) 0.5 (n = 50) 19.6 ± ± ± ± 25.1 > (n = 63) 18.1 ± ± ± ± 16.5 > 1 6 (n = 290) 23.4 ± ± ± ± 22.2 > 6 12 (n = 55) 24.8 ± 12.8, 41.0 ± ± ± 22.8, > 12 (n = 24) 35.8 ± 24.3, 43.1 ± ± ± 32.6, Overall (n = 482) 23.1 ± ± ± ± 23.1 Values are mean ± SD and they indicate each measured time (min). The sedation failure cases (n = 37) are excluded in this table. A Bonferroni-corrected significance level was considered in the post-hoc test (Mann-Whitney U test). *P < compared with Chloral hydrate only, P < compared with Chloral hydrate + Midazolam, P < compared with 0.5, P < compared with > 0.5 1, P < compared with > 1 6. Table 5. Adverse Events by Sedation Medication or Age Overall (n = 519) Chloral hydrate only (n = 482) Chloral hydrate + Midazolam (n = 24) Midazolam only (n = 13) 0.5 (n = 50) > (n = 65) > 1 6 (n = 303) > 6 12 (n = 67) > 12 (yr) (n = 34) Nausea/vomiting Prolonged sedation Hypoxia Fever Defecation Rigidity of limbs Cough Nasal stuffiness Overall Values are numbers of patients. There were no significant differences in the incidence of overall adverse events by sedation medication or age. 한합병증 (severe complication) 은없었다. 대부분의약제부작용이별다른처치없이저절로회복되었으며약제부작용발생에있어진정약제나환자의나이에따른유의한차이는없었다 (Table 5). 고찰본연구결과비마취과의사에의해수행된경구 chloral hydrate를이용한소아진정에서비교적높은진정성공률과낮은약제부작용발생률을보였으나, 전반적으로진정발현시간및회복시간이상당히길었고, 나이가많을수록진정발현이지연되었으며, 6세를넘는환아에서는진정실패율이더욱높았다. 안전에대한우려에도불구하고수술실밖에서비마취과 의료진에의한소아진정은수요증가와마취과의사인력의부족등의이유로국내외많은병원에서각종검사와시술에서흔히시행되고있다 [1-4]. 심지어는마취과의사를제외하고진정시행시어느정도의비용절감이있는지논하는연구도이루어지고있다 [5]. 하지만수술실밖에서이루어지는마취및진정은수술실내와비교하여여러가지면에서열악한경우가많다. 한정된좁은장소에서오래된마취 / 진정관련장비를사용하여경험이적은비숙련의료진에의해진정이시행되는경우예기치못한사고발생시에적절한대처를하기어렵다. 수술실의마취와비교할때비수술실에서의감시하전신마취 (monitored anesthesia care, MAC) 에서의료사고에의한소송이더많이발생하는것으로알려져있으며, 협조가잘안되는환자에서특히주의가요구된다 [14].

6 김영성외 5 인 :Pediatric sedation by non-anesthetists 371 최근들어소아를대상으로하는다양한검사및시술이늘어나고있고진정을통해소아의불안감이감소하고방해되는움직임이제한되므로검사및시술의진행에큰도움을줄수있어소아진정의필요성이더욱증가하고있으며그에따른안전하고효과적인소아진정의확립에대한필요성이절실히요구되고있다. 진정약물로는 chloral hydrate, midazolam, ketamine, propofol, dexmedetomidine 등이사용가능하나 [15-17], 약물의종류나용량에대한반응이환아개개인별로다르므로진정정도와지속시간을예측하기어렵다. 또한, 진정제용량을약간증량하는것만으로도갑작스럽게원치않는깊은진정 (deep sedation) 에빠지는경우가있어주의가요구된다. 어떠한약제및투여방법을사용하여소아진정을시행하는것이가장나은지에대한의견일치도이루어지지않은상태이다 [1,3]. 따라서진정시행시에각검사및시술의종류및통증정도에따라필요한진정의깊이와시간, 진정수행자의경험및개인적선호도, 나이및특이병력등의환자요소를모두고려해야한다. Chloral hydrate는비마약성진정 수면약제로가장오랫동안사용되어온약제중하나이다. 추천용량은 mg/kg 으로경구투여나직장투여시흡수가빠르며간과적혈구에서활성대사체로대사되는데효과의발현시간은 분, 작용유지시간은 2 8시간, 제거반감기는 4 12시간이다 [6,7]. 그러나 chloral hydrate는반복해서사용할경우활성대사체가축적되어부작용이발생가능하므로소아에서사용할때주의해야한다 [11]. 또한다른진정약제에비해 chloral hydrate의작용발현시간과지속시간을예측하기어려우며 [7], Choi 등 [12] 은정상환자군보다신경계질환이있는환자군에서실패율이더높았다고보고하였다 (18.4% vs. 47.8%). 하지만실제연구들의결과를살펴보면정상소아환자를대상으로 chloral hydrate의단독투여시진정성공률은 94.4% [18], 95.2% [4], 100% [13], 기타논문들에서는 % 정도로꽤높게보고되고있다. Midazolam은 benzodiazepine계약물로진정, 기억상실, 불안해소의효과가있으며다양한경로 경구, 비강, 근주, 정주 로약물을투여할수있어성인및소아진정에널리쓰인다. Midazolam 단독투여시, 특히본연구에서처럼정맥투여로사용시그진정효과및용량에대한국내연구가많지는않으나소아치과영역에서 4 6세의소아환자를대상으로 midazolam 0.1 또는 0.2 mg/kg를초기용량으로투여했을때만족할만한진정효과를확인하여경구투여를대신할수있는효과적인방법으로제시한보고가있다 [19]. 반면상황에따라그진정효과가불충분할수있다는보고들이있으며 [3,20], 부작용으로과잉수면, 저혈압, 호흡저하, 산소포화도감소등이발생할수있다 [3,21,22]. Chloral hydrate와달리길항제인 flumazenil이존재하여부작용시빠른대처가가능하나 역설적으로흥분을일으키는경우도 15% 까지보고되었다 [21]. 본연구를통해경구로 chloral hydrate를투여한환자에서상당히높은진정성공률과낮은약제부작용발생률을확인할수있었다. 본저자들의병원에서의소아환자를위한외래및병동의각종검사및비교적가벼운시술등은대부분소아진정실에서경구 chloral hydrate 투여를통한중등도진정 (moderate sedation) 의형태로진행이된다. 소아진정실에는진정코디네이터 ( 간호사 ) 가상주하여진정진료권자인주치의의투약지시에따라환아에게약물을투여하고본원소아진정운영지침및진정규정에따라환자상태를약물투여직전부터퇴실시까지지속해서감시하고진정에관련한모든제반기록을수행한다. 따라서비마취과의사가수행하는소아진정동안보다체계적이고안전한환아관리가가능하며, 소아진정과관련한모든절차및방법, 진정담당인력, 투약지침등이비교적통일되고표준화되어소아진정자료의수집및분석이용이하고신뢰성이높은장점이있다. 무엇보다본연구에포함된진정이대부분진정점수 4점의중등도진정수준 [23] 으로진행되었고대부분통증이없는검사나가벼운시술에국한되어있었다는점이높은성공률과연관이있을가능성이크다. Midazolam을투여한환아들은 chloral hydrate 단독투여군에비해진정성공률이떨어지는결과를보였으나실제로 midazolam 투여군에진정이어려울것이예상되는신경학적질환을가진환아혹은경구투여가불가능한환아의경우를포함하여 (Table 3) 편향 (bias) 의가능성이있어단정하기는어렵다. 또한 midazolam 투여군의환자수가적었던점, 회복시간은 midazolam 단독투여군에서더빨랐던점등을고려할때두약제간진정효용성및안전성비교에대해서추가적인연구가필요할것이다. 본연구결과에서 chloral hydrate 경구투여와 midazolam정주는각각단독투여시에진정발현시간에서는유의한차이를보이지않았고회복시간은 midazolam의경우에서유의하게빨랐다. 이는타연구들의경구 chloral hydrate 및 midazolam 투여결과와유사하며 [18,24], 본연구에서는두약제의병합사용의경우진정발현시간과회복시간모두유의하게증가하였는데, 이는병합투여군의대부분의환아가초회용량으로진정에실패하여추가진정약제를사용하였기때문에진정발현시간이증가하였고높은약물투여량과두약제의상호작용이회복시간지연에영향을미쳤을것이다. 연령에따른분류군간비교에서는회복시간에는유의한차이를보이지않았지만 1세이후에서나이가많아질수록진정발현시간이길어짐을볼수있었다. 이는타연구에서나이많은환아에서진정약제의추가투여횟수가더많았다는보고결과와상통한다 [4,25]. 또한본연구에서환아의나이가진정실패에영향을주는것으로나타났다. 즉, 환아

7 372 Anesth Pain Med Vol. 11, No. 4, 2016 의연령이 6세보다클때진정실패율이높았고환아의연령이진정실패를예측할수있는지민감도와특이도를각각구하여 ROC curve를그린결과 (Fig. 1), ROC curve 아래의면적은 0.732로중등도의정확성을보였으며민감도와특이도가가장높은값으로구해낸환아연령의절단값이 4.79세였다. 따라서 6세이상의환아에서는 chloral hydrate 이외의진정약제선택및방법을고려해보는것이소아진정실운영에효율적일수있을것이다. 약제부작용의경우 chloral hydrate를복용하였을때구토나기침등의증상을보이는경우가있었으나 midazolam에비해통계적으로유의한차이는아니었다. 다만본연구에포함된대상은건강한환아였기때문에구토로인한폐흡인등의심각한합병증발생은없었으나폐흡인의위험이있는고위험환아에서는더욱주의해서투약해야할것이다. 본연구의제한점은 ASA class I, II의비교적건강한환자들만대상으로하였고통증이없는검사나비교적통증이경한시술을대상으로하여대부분의환아에서진정깊이가중등도진정수준으로수행되어깊은진정에대한자료와진통제병용투여에대한자료가부족하였다는점으로이에대한추가연구가이루어져야할것이다. 본연구는국내비마취과의료인의소아진정시진정약제의선택에있어아직도중심이되는 chloral hydrate에의한소아진정을보다표준화, 전문화된체계 ( 소아진정실에서의소아진정통합운영및데이터관리 ) 를통해진행되는본원의실제결과자료값들을수집, 분석하여진정성공률, 진정및회복시간, 약제부작용을평가함으로써그효용성및안전성을파악하였다. 본연구에서제시한주요결과로서 chloral hydrate의진정성공률, 진정발현시간, 회복시간, 연령의따른효과차이등은기존의연구보고들과유사한측면도있으나, 국내대학병원에서여러비마취과의사에의해수행된다양한종류의대규모소아진정사례분석을통해보다현실적이고구체적인소아진정관련자료를제공하였다는점에서중요한의미가있다. 결론적으로본연구에포함된소아진정실에서비마취과의사에의해수행된경구 chloral hydrate를이용한소아진정에서높은성공률과낮은약제부작용발생률을확인하였다. 하지만전반적으로진정발현시간및회복시간이상당히길었던단점이존재하였고, 나이가많을수록진정발현이지연되었으며특히 6세를넘는환아에서는진정실패율이높았으므로이에대한보완및대체방법의모색이필요하리라판단되며이를위한추가적인연구가필요하다. 아울러소아진정수행에있어마취과의사의적극적인개입과이를통한효용성및안전성증대에관한연구수행이반드시필요할것이다. REFERENCES 1. Smallman B. Pediatric sedation: can it be safely performed by non-anesthesiologists? Curr Opin Anaesthesiol 2002; 15: Chiaretti A, Benini F, Pierri F, Vecchiato K, Ronfani L, Agosto C, et al. Safety and efficacy of propofol administered by paediatricians during procedural sedation in children. Acta Paediatr 2014; 103: Orel R, Brecelj J, Dias JA, Romano C, Barros F, Thomson M, et al. Review on sedation for gastrointestinal tract endoscopy in children by non-anesthesiologists. World J Gastrointest Endosc 2015; 7: Delgado J, Toro R, Rascovsky S, Arango A, Angel GJ, Calvo V, et al. Chloral hydrate in pediatric magnetic resonance imaging: evaluation of a 10-year sedation experience administered by radiologists. Pediatr Radiol 2015; 45: Kezerashvili A, Fisher JD, DeLaney J, Mushiyev S, Monahan E, Taylor V, et al. Intravenous sedation for cardiac procedures can be administered safely and cost-effectively by non-anesthesia personnel. J Interv Card Electrophysiol 2008; 21: Avlonitou E, Balatsouras DG, Margaritis E, Giannakopoulos P, Douniadakis D, Tsakanikos M. Use of chloral hydrate as a sedative for auditory brainstem response testing in a pediatric population. Int J Pediatr Otorhinolaryngol 2011; 75: Pershad J, Palmisano P, Nichols M. Chloral hydrate: the good and the bad. Pediatr Emerg Care 1999; 15: Ceçen E, Uygur O, Tosun A. Severe central nervous and respiratory system depression after sedation with chloral hydrate: a case report. Turk J Pediatr 2009; 51: Henderson GN, Yan Z, James MO, Davydova N, Stacpoole PW. Kinetics and metabolism of chloral hydrate in children: identification of dichloroacetate as a metabolite. Biochem Biophys Res Commun 1997; 235: McBay AJ, Boling VR Jr, Reynolds PC. Spectrophotometric determination of trichloroethanol in chloral hydrate poisoning. J Anal Toxicol 1980; 4: Heistein LC, Ramaciotti C, Scott WA, Coursey M, Sheeran PW, Lemler MS. Chloral hydrate sedation for pediatric echocardiography: physiologic responses, adverse events, and risk factors. Pediatrics 2006; 117: e Choi YS, Son YJ, Song ES, Cho YK, Kim YO, Kim CJ, et al. Effect of chloral hydrate used for pediatric sedation. J Korean Child Neurol Soc 2008; 16: D'Agostino J, Terndrup TE. Chloral hydrate versus midazolam for sedation of children for neuroimaging: a randomized clinical trial. Pediatr Emerg Care 2000; 16: Robbertze R, Posner KL, Domino KB. Closed claims review of anesthesia for procedures outside the operating room. Curr Opin Anaesthesiol 2006; 19: Choi YJ, Kim MH, Song CS, Kim SH, Hong JY, Suk EH, et al. Sedation and general anesthesia outside of the operating room. Anesth Pain Med 2012; 7:

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012임수진

012임수진 Received : 2012. 11. 27 Reviewed : 2012. 12. 10 Accepted : 2012. 12. 12 A Clinical Study on Effect of Electro-acupuncture Treatment for Low Back Pain and Radicular Pain in Patients Diagnosed with Lumbar