clinical study the effects of single-dose rectal midazolam...

Clinical StudyThe Effects of Single-Dose Rectal Midazolam Application onPostoperative Recovery Sedation and Analgesia in ChildrenGiven Caudal Anesthesia Plus Bupivacaine

Sedat Saylan1 Ahmet Eroglu2 and Davut Dohman2

1 Department of Anesthesiology and Reanimation Kanuni Education and Research Hospital 61290 Trabzon Turkey2Department of Anesthesiology and Reanimation Faculty of Medicine Karadeniz Technical University 61080 Trabzon Turkey

Correspondence should be addressed to Sedat Saylan sedatsaylanyahoocom

Received 4 December 2013 Revised 7 March 2014 Accepted 9 April 2014 Published 5 May 2014

Academic Editor Engin Erturk

Copyright copy 2014 Sedat Saylan et al This is an open access article distributed under the Creative Commons Attribution Licensewhich permits unrestricted use distribution and reproduction in any medium provided the original work is properly cited

BackgroundThis study aimed to compare the effects of rectal midazolam addition after applying bupivacaine and caudal anesthesiaon postoperative analgesia time the need for additional analgesics postoperative recovery and sedation and to find out its adverseeffects in children having lower abdominal surgery Methods 40 children between 2 and 10 years of ASA I-II were randomizedand they received caudal anesthesia under general anesthesia Patients underwent the application of caudal block in addition tosaline and 1mLkg bupivacaine 025 In the postoperative period Group C (n = 20) was given 5mL saline and Group M (n =20) was given 030mgkg rectal midazolam diluted with 5mL saline Sedation scale and postoperative pain scale (CHIPPS) of thepatients were evaluated The patients were observed for their analgesic need first analgesic time and adverse effects for 24 hoursResults Demographic and hemodynamic data of the two groups did not differ Postoperative sedation scores in both groups weresignificantly lower compared with the preoperative period There was no significant difference between the groups in terms ofsedation and sufficient analgesia Conclusions We conclude that caudal anesthesia provided sufficient analgesia in peroperative andpostoperative periods and rectal midazolam addition did not create any differences This trial is registered with ClinicalTrialsgovNCT02127489

1 Introduction

Pediatric patients need good recovery sedation and analgesiaafter surgery Comfortable recovery period relaxes childrenincreases parent satisfaction and provides doctor easierpostoperative monitoring As caudal analgesia is simplereliable and effective in postoperative analgesia it is widelyused in pediatric patients [1ndash3]

In postoperative period less agitation and analgesicrequirement is reported in children with caudal block afterthe induction of general anesthesia However postoperativeanalgesic effect may end early with a single dose of caudallocal anesthetic and additional analgesia may be requiredResearchers have started to use various drugs alone or incombination with other drugs in a caudal way to ensureeffective and long-lasting analgesia Rectal midazolam isreported to provide good sedation and inhibit agitation inpediatric patients [4 5]

In this study a noninvasive application of 030mgkgrectal midazolam was added to caudal anesthesia providingeffective postoperative analgesia We aimed to find out theeffects of 030mgkg rectal midazolam addition after caudalanesthesiawith 025bupivacaine on postoperative analgesiatime the need for additional analgesics postoperative recov-ery and sedation in children The adverse effects were alsostudied

2 Methods

After the approval of local ethics committee and informedparental consent 40 children (ASA physical status I-II age2ndash10 years) scheduled for lower abdominal surgery were ran-domly allocated to two groups of twenty each Children withsignificant respiratory system circulatory system and liverand kidney function disorder and history of allergy to thedrugs to be studied those who received analgesic medication

Hindawi Publishing CorporationBioMed Research InternationalVolume 2014 Article ID 127548 6 pageshttpdxdoiorg1011552014127548

2 BioMed Research International

before the operation and those for whom caudal anesthesiais contraindicated clinically were excluded from the studyControl Group (Group C) received caudal anesthesia withbupivacaine and GroupMidazolam (GroupM) received rec-tal midazolam following caudal anesthesia with bupivacaine

No premedication was given to the patients Noninvasivearterial blood pressure pulse oxygen saturation and tem-perature were recorded preoperatively with 4-point sedationscale

Sedation scale for preoperative and postoperative assess-ment (1ndash4 points) represents the following states

(1) calm(2) not quiet but easy to calm(3) not easy to calm moderately agitated or restless(4) angry excited or disoriented

After monitoring the ECG noninvasive blood pressure andperipheral oxygen saturation (Drager Cato Germany) andmeasuring the temperature of the patients taken to the oper-ating room sevoflurane was maintained with 50 nitrousoxide in O

2 with induction starting at a concentration of 8

and fall by 2-3 After obtaining adequate depth of anesthe-sia venous cannulation (Mediflon 22G or 24G India) wasperformed Patients were intubated after the use of 05mgkgatracurium for muscle relaxation No analgesic drug wasused A warming blanket was used to prevent hypothermiaduring surgery Patients in both groups were given lateraldecubitus position for caudal block implementation andinjected with 025 bupivacaine of 1mLkg volume dilutedwith saline slowly after which the children were immediatelyturned supine The maximum volume was 20mL

Mechanical ventilator (Drager Cato Germany) wasadjusted to end-tidal CO

2respiratory rate within the normal

range and the volume continued at controlled ventilationAnesthesia was maintained with 50 of O

2 50 of N

2O

and 15ndash4 of sevoflurane The depth of anesthesia bloodpressure and heart rate values were maintained at plusmn20 ofthe initial values by changing the concentration of sevoflu-rane None of the patients were given extra analgesic duringanesthesia

Systolic blood pressure (mmHg) heart rate (beatsmin)peripheral oxygen saturation (SpO

2) and temperature values

were recorded before the operation after the application ofcaudal block at 5 10 15 and 30 minutes during surgeryand after the operation In addition anesthesia and operationtime was recorded 5mL of rectal applicators to be used aftersurgical intervention was prepared by another anesthetistwho was not involved in the study Group C was given5mL of saline and Group M was given 030mgkg ofmidazolam diluted with 5mL of saline rectally The follow-up of the patients was done by an anesthetist who was notaware of the drug applied Patients taken to postanesthesiacare unit (PACU) were assessed by a sedation scale and apostoperative pain scale (CHIPPSTheChildrenrsquos and InfantsrsquoPostoperative Pain Scale) Patients with sedation scale over 2were given 005ndash01mgkg midazolam for sedation Patientswith postoperative sedation scale over 3 were given 10ndash20mgkg of rectal paracetamol to stop the pain Patients who

Table 1 Demographic data duration of operation and types ofoperation

Group C(mean plusmn SD)

Group M(mean plusmn SD) 119875 value

Age (months) 629 plusmn 256 560 plusmn 249 0359Weight (kg) 192 plusmn 62 194 plusmn 53 0857Height (cm) 1115 plusmn 138 1107 plusmn 157 0935Duration ofanesthesia (min) 605 plusmn 237 563 plusmn 166 0515

Duration ofoperation (min) 455 plusmn 216 411 plusmn 151 0806

Operation typesHypospadias 6 6Buried penis 1 3Cryptorchism 6 3Inguinal hernia 4 6Circumcision 2 1Hydrocele 1 1

were painless calm and with Aldrete Scale over 9 were sentto the related department

21 Statistical Analysis Conformity of the data obtained inmeasurements to the normal distribution was analyzed withKolmogorov-Smirnov test In the comparison of quantitativedata of the two groups (control and midazolam groups)data that are in conformity with normal distribution wereanalyzed with Studentrsquos t-test and data not conforming tonormal distribution were analyzed with the Mann-WhitneyU test In the comparison of repeated measurements ofintragroups data that are in conformitywith normal distribu-tion in repeated measurements were analyzed with ANOVA(paired t-test as post hoc) and data not conforming to normaldistribution were analyzed with Friedman test (Wilcoxontest as post hoc) Data obtained by measurements weregiven as mean plusmn standard deviation The level of statisticalsignificance was accepted as 119875 lt 005 For the studieswith multiple statistical significance comparisons (post hoc)ldquo005comparison numberrdquo was used

3 Results

40 patients were included in this study 20 in each groupCaudal blockade was performed successfully at the firstattempt in all children No patient was excluded from thestudy There were no significant differences between groupsin demographic data (age weight and height) and durationof operation (119875 gt 005) (Table 1)

Systolic arterial pressure (SAP) diastolic arterial pressure(DAP) and mean arterial pressure (MAP) measurementswere shown in Table 2 In Group C SAP at the 5th minutefollowing caudal application was significantly lower than inGroup M (119875 = 0006) Timely changes of SAP DAP andMAP values decreased in Group M which was statisticallysignificant (119875 = 0024 119875 lt 0005 and 119875 lt 0005 resp)

BioMed Research International 3

Table 2 Comparison of groups by SAP DAP and MAP

Group C (mean plusmn SD) Group M (mean plusmn SD) 119875 valueSAP

Preoperation 997 plusmn 243 1068 plusmn 86 0229Before caudal 973 plusmn 66 1003 plusmn 84 02175thmin after caudal 965 plusmn 67 1030 plusmn 71 0006lowast

10thmin after caudal 970 plusmn 82 1004 plusmn 62 014115thmin after caudal 956 plusmn 81 988 plusmn 70 019030min after caudal 942 plusmn 66 973 plusmn 80 0212Postoperation 1030 plusmn 92 1033 plusmn 64 0921

DAPPreoperation 599 plusmn 102 569 plusmn 95 0351Before caudal 535 plusmn 62 537 plusmn 84 09335thmin after caudal 500 plusmn 84 531 plusmn 88 026210thmin after caudal 507 plusmn 85 506 plusmn 83 097015thmin after caudal 484 plusmn 81 481 plusmn 88 089630min after caudal 473 plusmn 103 447 plusmn 84 0411Postoperation 589 plusmn 124 537 plusmn 108 0163

MAPPreoperation 737 plusmn 105 720 plusmn 94 0581Before caudal 669 plusmn 59 678 plusmn 82 07095thmin after caudal 640 plusmn 82 668 plusmn 80 028910thmin after caudal 635 plusmn 86 641 plusmn 79 080515thmin after caudal 622 plusmn 83 623 plusmn 79 096930min after caudal 602 plusmn 93 591 plusmn 77 0699Postoperation 729 plusmn 131 672 plusmn 95 0127

lowastWhen SAP value at the 5thmin after caudal in Group M is compared with that in Group C

95

100

105

110

115

120

125

Preo

pera

tive

Prec

auda

l

Posto

pera

tiveH

eart

rate

(min

)

Time

Heart rate (HR) values

CM

Afte

rcau

dal1

5998400

Afte

rcau

dal1

0998400

Afte

rcau

dal5

998400

Afte

rcau

dal3

0998400

Figure 1 Heart rate values of patients (pc precaudal ac aftercaudal)

Figure 1 shows the changes in heart rate of the groupsTimely changes of heart rate values in Group C and GroupM were statistically significant (119875 = 0034 and 119875 = 0015resp) Values of heart rate in both groups decreased in thepostoperative period and after caudal application comparedto preoperative and precaudal periods However there wereno statistical differences between the groups

Sedation scores of the groups are shown in Figure 2Timely changes in sedation scale of Group C and Group M

0

05

1

15

2

25

3

35

Sedation scale

CM

+

lowast

Preoperative Postoperative

Figure 2 Sedation scale of the groups lowastP = 0021 when sedationscale in preoperative period is compared with that in postoperativeperiod in Group C +P = 0005 when sedation scale in preoperativeperiod is compared with that in postoperative period in Group M

decreased in postoperative period compared to preoperativeperiod which was statistically significant (119875 = 0021 and 119875 =0005 resp) There was no statistically significant differencebetween the groups

There was no significant difference between CHIPPS andAldrete Scales of the groups (Figure 3) As for side effects


minus2

0

2

4

6

8

10

12

CHIPPS Aldrete

CHIPPS and Aldrete Scales

CM

Figure 3 CHIPPS and Aldrete Scales of the groups

Table 3 Side effects in patients in both groups

Side effects Group C Group M119899 119899

Agitation 1 50 mdash mdashVomiting 1 50 3 150Urinary retention mdash mdash 1 50No side effect 18 900 16 800

agitation was observed in 1 patient and vomiting in anotherpatient in Group C Vomiting was observed in 3 patients andurinary retention in 1 patient in Group M (Table 3)

First analgesic time in Group C was 2254 plusmn 3245minwhile 7 patients did not require any analgesics for 24 hoursFirst analgesic time in Group M was 2805 plusmn 3004minwhile 9 patients did not require any analgesics for 24 hoursThe groups did not show statistically significant difference interms of first analgesic time (119875 = 0581)

4 Discussion

This study showed that caudal anesthesia provided sufficientanalgesia in perioperative and postoperative periods how-ever rectal midazolam addition did not create any differ-ences We used CHIPPS and Aldrete Scales for evaluation ofsedation and recovery of patientsThemost widely used scaleis CHIPPS which is applied to children from 6 months to12 years This is a reliable postoperative pain scoring systemwith five behavioral criteria crying facial expression motoractivity posture and leg movement [6ndash8] Aldrete recoveryscore is a frequently used postanesthesia intensive care unitdischarge scoring system with five main criteria activityrespiration circulation consciousness and colour Patientswith Aldrete score of 9 and above are safe to discharge Inour study all of the patients were followed for 24 hours atthe service for the first postoperative analgesic duration andcomplications (nausea vomiting motor block hypotensionbradycardia urinary retention etc)

The management of postoperative pain requires tak-ing preventive measures Regional anesthesia is often usedtogether with general anesthesia in children [9 10] Cau-dal block has many characteristics such as early return tonormal activity and excellent and fast analgesia in inguinaland genital areas Various studies have shown that ACTHimmunoreactive beta-endorphin ADH cortisol prolactinand glucose levels are less affected after caudal block com-pared with general anesthesia [11 12] Caudal administra-tion of bupivacaine is routinely used in pediatric patientsundergoing genitourinary surgical procedures for improvingpostoperative pain relief [13 14] Although the effect of caudalanalgesia with bupivacaine on postoperative pain relief hasbeen extensively investigated in children we did not findany study which included rectal midazolam for postoperativesedation Therefore we decided to study it

Da Conceicao and Coelho [15] found that children given0375 caudal bupivacaine had first analgesic requirement 5hours later Different studies found different analgesia timein caudal application of bupivacaine which may be due todifferences in types of surgery pain scoring systems drugdosage and volume analgesia time assessment methods andfamily factor [15] In our study first analgesic requirementtime was 2254 plusmn 3245min in Group C and 7 patients didnot need any for 24 hours It was 2805 plusmn 3004min in GroupM and 9 patients did not need any for 24 hours The groupsdid not show statistically significant difference in terms of thefirst analgesic time (119875 = 0581)

Lower abdominal and genitourinary operations can leadto severe postoperative pain therefore it may cause agitationand restlessness in children [16ndash18] Breschan et al [19]reported that of 1845 single-dose caudal block applicationswith bupivacaine only 2 patients developed total spinal blockas a major complication who were intubated ventilated andextubated in 4 hours without any significant cardiovasculardepression Three patients had urinary retention in the samestudy In our study 1 patient had agitation and 1 patient hadvomiting in Group C and 3 patients had vomiting and 1patient had urinary retention in Group M Kanegaye et al[5] reported that patient anxiety and unwanted movementscan be frequently seen in pediatric operations even witheffective local anesthesia but adequate sedation procedurecan improve technical results and increase patient parentaland doctor satisfaction They claimed that midazolam isthe best sedative to have true state of sedation in childrenand provide required levels of security anxiety amnesiaquickness in movement after use and pharmacologicalreversibility Pediatric transmucosal midazolam applicationwas first used by rectal intranasal and sublingual waysfor sedation before anesthesia took growing interest byresearchers and has become widely used Kanegaye et al [5]reported that midazolam is suitable for emergency pediatricpatients and can be applied with a painless injection In ourstudy we chose rectal midazolam which is known to be aneffective easily absorbable and noninvasive method whenadministered rectally [4]

Kanegaye et al [5] compared two different doses of rectalmidazolam used at pediatric emergency department in termsof sedative efficacy and frequency of agitation A group of


patients taking cutaneous procedures were given 05mgkgstandard dose while another group was given 1mgkg rectalmidazolamThey concluded that rectal midazolam improvedsedation scores before operation and 1mgkgmidazolamwasmore effective However insufficient sedation was recordedin 27 to 50 of the patients with high doses and 27 ofthe patients had prolonged agitation which is a disadvantagefor the use of rectal midazolam They suggest that doctorsshould consider the possibility of dose-dependent inadequatesedation and agitation before choosing rectal midazolam forpediatric sedation [5] In our study agitation was observed inone patient in Group C but none in Group M

Mahajan et al [20] evaluated the analgesic efficacy ofmidazolam and bupivacaine mixture in children undergoinggenitourinary operations to relieve postoperative pain andalso evaluated its side effects They gave a single caudalinjection of 05mLkg 025 bupivacaine to the first groupand 05mLkg 025 bupivacaine together with 05mLkg50microgkgmidazolam to the second groupThey observedheart rate arterial blood pressure and oxygen saturationand assessed postoperative pain via an objective pain scoreat regular intervals for 12 hours An analgesic was givenwhen pain score was 4 or greater Duration of analgesiaas well as additional analgesic need was determined Theyconcluded that bupivacaine plus midazolam caudal applica-tion compared with single-dose bupivacaine provided longerpostoperative analgesia without any side effects [20] In ourstudy SAP DAP MAP and heart rate decreased signifi-cantly in both groups after caudal anesthesia compared withpreoperative period but there was no significant differencebetween groups Sedation scale of both groups decreasedin postoperative period compared with preoperative periodbut there was no statistically significant difference betweengroups No differences occurred in CHIPPS and Aldretescores of the groupsNodifferenceswere determined betweengroups in terms of adverse effects and first analgesic time

In conclusion we found in our study that the additionof 030mgkg rectal midazolam after caudal anesthesia withbupivacaine makes no difference in postoperative analgesiatime additional analgesia requirement postoperative recov-ery the effectiveness in ensuring sedation and side effectsin children having lower abdominal surgery but caudalapplication of 025 bupivacaine provided effective andsufficient postoperative analgesia

Conflict of Interests

The authors declare that there is no conflict of interestsregarding the publication of this paper

Acknowledgments

This study was done at Karadeniz Technical UniversityFaculty of Medicine following the approval of local ethicscommittee The authors thank all the staff of the anesthesi-ology department and the nursing staff of the pediatric wardsfor their excellent help and support

References

[1] R Sumpelman and S Munte ldquoPostoperative Analgesia ininfants and childrenrdquo Current Opinion in Anaesthesiology vol16 no 3 pp 309ndash313 2003

[2] HM Lee andGM Sanders ldquoCaudal ropivacaine and ketaminefor postoperative analgesia in childrenrdquoAnaesthesia vol 55 no8 pp 806ndash810 2000

[3] P Silvani A Camporesi M R Agostino and I Salvo ldquoCaudalanesthesia in pediatrics an updaterdquo Minerva Anestesiologicavol 72 no 6 pp 453ndash459 2006

[4] T G Clausen J Wolff P B Hansen et al ldquoPharmacokineticsof midazolam and 120572-hydroxy-midazolam following rectal andintravenous administrationrdquo British Journal of Clinical Pharma-cology vol 25 no 4 pp 457ndash463 1988

[5] J T Kanegaye J L Favela M Acosta and D E Bank ldquoHigh-dose rectal midazolam for pediatric procedures a randomizedtrial of sedative efficacy and agitationrdquo Pediatric EmergencyCare vol 19 no 5 pp 329ndash336 2003

[6] P J McGrath and L McAlpine ldquoPsychologic perspectives onpediatric painrdquo Journal of Pediatrics vol 122 no 5 pp S2ndashS81993

[7] D C Tyler A Tu J Douthit and C R Chapman ldquoTowardvalidation of pain measurement tools for children A PilotStudyrdquo Pain vol 52 no 3 pp 301ndash309 1993

[8] I Shavit I Keidan and A Augarten ldquoThe practice of pediatricprocedural sedation and analgesia in the emergency depart-mentrdquo European Journal of Emergency Medicine vol 13 no 5pp 270ndash275 2006

[9] R C Roy ldquoChoosing general versus regional anesthesia for theelderlyrdquo Anesthesiology Clinics of North America vol 18 no 1pp 91ndash104 2000

[10] M F Folstein S E Folstein and P R McHugh ldquoMini-mentalstate a practical method of grading the cognitive state ofpatients for the clinicianrdquo Journal of Psychiatric Research vol12 pp 189ndash198 1975

[11] M Somri L A Gaitini S J Vaida et al ldquoEffect of ilioinguinalnerve block on the catecholamine plasma levels in orchidopexycomparisonwith caudal epidural blockrdquo Paediatric Anaesthesiavol 12 no 9 pp 791ndash797 2002

[12] M Solak H Ulusoy and H Sarihan ldquoEffects of caudal blockon cortisol and prolactin responses to postoperative pain inchildrenrdquo European Journal of Pediatric Surgery vol 10 no 4pp 219ndash223 2000

[13] B Golianu E J Krane K S Galloway andM Yaster ldquoPediatricacute painmanagementrdquoPediatric Clinics of NorthAmerica vol47 no 3 pp 559ndash587 2000

[14] A Martinez-Telleria M E Cano Serrano M J Martinez-Telleria et al ldquoAnalysis of regional anesthetic efficacy in pedi-atric postoperative painrdquo Cirugia Pediatrica vol 10 pp 18ndash201997

[15] M J Da Conceicao and L Coelho ldquoCaudal anaesthesiawith 0375 ropivacaine or 0375 bupivacaine in paediatricpatientsrdquo British Journal of Anaesthesia vol 80 no 4 pp 507ndash508 1998

[16] D S Gann and M P Lilly ldquoThe neuroendocrine response tomultiple traumardquoWorld Journal of Surgery vol 7 no 1 pp 101ndash118 1983

[17] H Kehlet ldquoThe stress response to surgery release mechanismsand the modifying effect of pain reliefrdquo Acta Chirurgica Scandi-navica Supplement vol 155 no 550 pp 22ndash28 1989


[18] C E Reier J M George and J W Kilman ldquoCortisol andgrowth hormone response to surgical stress during morphineanesthesiardquo Anesthesia and Analgesia vol 52 no 6 pp 1003ndash1010 1973

[19] C Breschan H V Schalk F Schaumberger and R LikarldquoExperience with caudal blocks in children over a period of35 yearsrdquoActaAnaesthesiologica Scandinavica Supplement vol40 no 109 pp 174ndash176 1996

[20] R Mahajan Y K Batra V K Grover and J Kajal ldquoA compar-ative study of caudal bupivacaine and midazolam-bupivacainemixture for post-operative analgesia in children undergoinggenitourinary surgeryrdquo International Journal of Clinical Phar-macology andTherapeutics vol 39 no 3 pp 116ndash120 2001

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before the operation and those for whom caudal anesthesiais contraindicated clinically were excluded from the studyControl Group (Group C) received caudal anesthesia withbupivacaine and GroupMidazolam (GroupM) received rec-tal midazolam following caudal anesthesia with bupivacaine

No premedication was given to the patients Noninvasivearterial blood pressure pulse oxygen saturation and tem-perature were recorded preoperatively with 4-point sedationscale

Sedation scale for preoperative and postoperative assess-ment (1ndash4 points) represents the following states

(1) calm(2) not quiet but easy to calm(3) not easy to calm moderately agitated or restless(4) angry excited or disoriented

After monitoring the ECG noninvasive blood pressure andperipheral oxygen saturation (Drager Cato Germany) andmeasuring the temperature of the patients taken to the oper-ating room sevoflurane was maintained with 50 nitrousoxide in O

2 with induction starting at a concentration of 8

and fall by 2-3 After obtaining adequate depth of anesthe-sia venous cannulation (Mediflon 22G or 24G India) wasperformed Patients were intubated after the use of 05mgkgatracurium for muscle relaxation No analgesic drug wasused A warming blanket was used to prevent hypothermiaduring surgery Patients in both groups were given lateraldecubitus position for caudal block implementation andinjected with 025 bupivacaine of 1mLkg volume dilutedwith saline slowly after which the children were immediatelyturned supine The maximum volume was 20mL

Mechanical ventilator (Drager Cato Germany) wasadjusted to end-tidal CO

2respiratory rate within the normal

range and the volume continued at controlled ventilationAnesthesia was maintained with 50 of O

2 50 of N

2O

and 15ndash4 of sevoflurane The depth of anesthesia bloodpressure and heart rate values were maintained at plusmn20 ofthe initial values by changing the concentration of sevoflu-rane None of the patients were given extra analgesic duringanesthesia

Systolic blood pressure (mmHg) heart rate (beatsmin)peripheral oxygen saturation (SpO

2) and temperature values

were recorded before the operation after the application ofcaudal block at 5 10 15 and 30 minutes during surgeryand after the operation In addition anesthesia and operationtime was recorded 5mL of rectal applicators to be used aftersurgical intervention was prepared by another anesthetistwho was not involved in the study Group C was given5mL of saline and Group M was given 030mgkg ofmidazolam diluted with 5mL of saline rectally The follow-up of the patients was done by an anesthetist who was notaware of the drug applied Patients taken to postanesthesiacare unit (PACU) were assessed by a sedation scale and apostoperative pain scale (CHIPPSTheChildrenrsquos and InfantsrsquoPostoperative Pain Scale) Patients with sedation scale over 2were given 005ndash01mgkg midazolam for sedation Patientswith postoperative sedation scale over 3 were given 10ndash20mgkg of rectal paracetamol to stop the pain Patients who

Table 1 Demographic data duration of operation and types ofoperation

Group C(mean plusmn SD)

Group M(mean plusmn SD) 119875 value

Age (months) 629 plusmn 256 560 plusmn 249 0359Weight (kg) 192 plusmn 62 194 plusmn 53 0857Height (cm) 1115 plusmn 138 1107 plusmn 157 0935Duration ofanesthesia (min) 605 plusmn 237 563 plusmn 166 0515

Duration ofoperation (min) 455 plusmn 216 411 plusmn 151 0806

Operation typesHypospadias 6 6Buried penis 1 3Cryptorchism 6 3Inguinal hernia 4 6Circumcision 2 1Hydrocele 1 1

were painless calm and with Aldrete Scale over 9 were sentto the related department

21 Statistical Analysis Conformity of the data obtained inmeasurements to the normal distribution was analyzed withKolmogorov-Smirnov test In the comparison of quantitativedata of the two groups (control and midazolam groups)data that are in conformity with normal distribution wereanalyzed with Studentrsquos t-test and data not conforming tonormal distribution were analyzed with the Mann-WhitneyU test In the comparison of repeated measurements ofintragroups data that are in conformitywith normal distribu-tion in repeated measurements were analyzed with ANOVA(paired t-test as post hoc) and data not conforming to normaldistribution were analyzed with Friedman test (Wilcoxontest as post hoc) Data obtained by measurements weregiven as mean plusmn standard deviation The level of statisticalsignificance was accepted as 119875 lt 005 For the studieswith multiple statistical significance comparisons (post hoc)ldquo005comparison numberrdquo was used

3 Results

40 patients were included in this study 20 in each groupCaudal blockade was performed successfully at the firstattempt in all children No patient was excluded from thestudy There were no significant differences between groupsin demographic data (age weight and height) and durationof operation (119875 gt 005) (Table 1)

Systolic arterial pressure (SAP) diastolic arterial pressure(DAP) and mean arterial pressure (MAP) measurementswere shown in Table 2 In Group C SAP at the 5th minutefollowing caudal application was significantly lower than inGroup M (119875 = 0006) Timely changes of SAP DAP andMAP values decreased in Group M which was statisticallysignificant (119875 = 0024 119875 lt 0005 and 119875 lt 0005 resp)









95

100

105

110

115

120

125

Preo

pera

tive

Prec

auda

l

Posto

pera

tiveH

eart

rate

(min

)

Time


CM

Afte

rcau

dal1

5998400

Afte

rcau

dal1

0998400

Afte

rcau

dal5

998400

Afte

rcau

dal3

0998400




0

05

1

15

2

25

3

35

Sedation scale

CM

+

lowast






minus2

0

2

4

6

8

10

12

CHIPPS Aldrete


CM







4 Discussion












Acknowledgments


References



























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of
























95

100

105

110

115

120

125

Preo

pera

tive

Prec

auda

l

Posto

pera

tiveH

eart

rate

(min

)

Time


CM

Afte

rcau

dal1

5998400

Afte

rcau

dal1

0998400

Afte

rcau

dal5

998400

Afte

rcau

dal3

0998400




0

05

1

15

2

25

3

35

Sedation scale

CM

+

lowast






minus2

0

2

4

6

8

10

12

CHIPPS Aldrete


CM







4 Discussion












Acknowledgments


References



























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of

















minus2

0

2

4

6

8

10

12

CHIPPS Aldrete


CM







4 Discussion












Acknowledgments


References



























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of






















Acknowledgments


References



























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of

























of






Disease Markers



OncologyJournal of





PPAR Research



Journal of

ObesityJournal of
















clinical study the effects of single-dose rectal midazolam...

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