Non-pharmacological interventions for assisting the induction of anaesthesia in children (Review) Yip P, MiddletonP, Cyna AM, Carlyle AV ThisisareprintofaCochranereview,preparedandmaintainedbyTheCochraneCollaborationandpublishedinTheCochraneLibrary 2010,Issue11 http://www.thecochranelibrary.com Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. TABLE OF CONTENTS HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 PLAINLANGUAGESUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 AUTHORS’CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 CHARACTERISTICSOFSTUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 DATAANDANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Analysis1.2.Comparison1parentalpresenceversusnoparentalpresence,Outcome2Anxietyduringinduction. . . 33 Analysis1.4.Comparison1parentalpresenceversusnoparentalpresence,Outcome4Cooperationduringinduction(poor complianceICC>6)c. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 Analysis1.6.Comparison1parentalpresenceversusnoparentalpresence,Outcome6Parentalanxiety. . . . . . 35 Analysis1.7.Comparison1parentalpresenceversusnoparentalpresence,Outcome7Parentalanxiety. . . . . . 37 Analysis1.9.Comparison1parentalpresenceversusnoparentalpresence,Outcome9Emergencedelirium. . . . 38 Analysis1.11.Comparison1parentalpresenceversusnoparentalpresence,Outcome11Timetakenforinduction (minutes). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Analysis1.12.Comparison1parentalpresenceversusnoparentalpresence,Outcome12Negativebehaviourpostop. 39 Analysis1.13.Comparison1parentalpresenceversusnoparentalpresence,Outcome13Negativebehaviourpostop. 40 Analysis1.15.Comparison1parentalpresenceversusnoparentalpresence,Outcome15Parentalsatisfaction. . . . 41 Analysis1.16.Comparison1parentalpresenceversusnoparentalpresence,Outcome16Parentalsatisfaction. . . . 42 Analysis2.1.Comparison2parentalpresenceversusmidazolam,Outcome1anxietyduringinduction. . . . . . 44 Analysis2.2.Comparison2parentalpresenceversusmidazolam,Outcome2cooperationduringinduction. . . . 44 Analysis2.4.Comparison2parentalpresenceversusmidazolam,Outcome4parentalanxiety. . . . . . . . . 45 Analysis2.5.Comparison2parentalpresenceversusmidazolam,Outcome5timetakenforinduction(minutes). . . 45 Analysis2.6.Comparison2parentalpresenceversusmidazolam,Outcome6negativebehaviourpostop. . . . . . 46 Analysis2.7.Comparison2parentalpresenceversusmidazolam,Outcome7emergencedelirium. . . . . . . . 46 Analysis2.9.Comparison2parentalpresenceversusmidazolam,Outcome9parentalsatisfaction. . . . . . . . 47 Analysis3.1.Comparison3parentalpresence+midazolamversusnoparentalpresence,Outcome1parentalanxiety. . 48 Analysis3.2.Comparison3parentalpresence+midazolamversusnoparentalpresence,Outcome2parentalanxiety. . 49 Analysis7.1.Comparison7videogameversuscontrol,Outcome1Anxietyduringinduction. . . . . . . . . 51 Analysis7.2.Comparison7videogameversuscontrol,Outcome2Negativebehaviourpostop. . . . . . . . . 51 Analysis8.1.Comparison8videogameversusmidazolam,Outcome1Anxietyduringinduction. . . . . . . . 52 Analysis8.2.Comparison8videogameversusmidazolam,Outcome2Negativebehaviourpostop. . . . . . . 52 Analysis9.1.Comparison9clowndoctors,Outcome1anxietyduringinduction. . . . . . . . . . . . . 53 Analysis9.2.Comparison9clowndoctors,Outcome2parentalanxiety. . . . . . . . . . . . . . . . . 53 Analysis10.1.Comparison10hypnosisversusmidazolam,Outcome1anxietyduringinduction. . . . . . . . 54 Analysis10.2.Comparison10hypnosisversusmidazolam,Outcome2negativebehaviourpostop. . . . . . . . 54 Analysis11.1.Comparison11lowsensorystimulationversuscontrol,Outcome1cooperationatinduction. . . . 55 Analysis11.2.Comparison11lowsensorystimulationversuscontrol,Outcome2parentalanxiety. . . . . . . 55 Analysis12.1.Comparison12acupunctureforparents,Outcome1anxietyduringinduction. . . . . . . . . 56 Analysis12.2.Comparison12acupunctureforparents,Outcome2cooperationduringinduction. . . . . . . 56 Analysis12.3.Comparison12acupunctureforparents,Outcome3parentalanxiety. . . . . . . . . . . . 57 Analysis12.4.Comparison12acupunctureforparents,Outcome4anxietyonenteringinductionarea. . . . . . 58 Analysis13.1.Comparison13videosforparents,Outcome1parentalanxiety. . . . . . . . . . . . . . . 58 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 WHAT’SNEW . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) i Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. HISTORY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 CONTRIBUTIONSOFAUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 DECLARATIONSOFINTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 SOURCESOFSUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 DIFFERENCESBETWEENPROTOCOLANDREVIEW . . . . . . . . . . . . . . . . . . . . . 61 INDEXTERMS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) ii Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. [InterventionReview] Non-pharmacological interventions for assisting the induction of anaesthesia in children PeggyYip2,PhilippaMiddleton3,AllanMCyna1,AlisonVCarlyle4 1DepartmentofWomen’sAnaesthesia,Women’sandChildren’sHospital,Adelaide,Australia.2DepartmentofPaediatricAnaesthesia, StarshipChildren’sHospital,Auckland,NewZealand.3ARCH:AustralianResearchCentreforHealthofWomenandBabies,Discipline of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, Australia. 4Department of Anaesthesia, Princess Margaret Hospital,Subiaco,Australia Contact address: AllanM Cyna, Department of Women’s Anaesthesia, Women’s and Children’sHospital, 72 King William Road, Adelaide,SouthAustralia,5006,[email protected]. Editorialgroup:CochraneAnaesthesiaGroup. Publicationstatusanddate:Edited(nochangetoconclusions),publishedinIssue11,2010. Reviewcontentassessedasup-to-date: 13December2008. Citation: YipP,MiddletonP,CynaAM,CarlyleAV.Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiain children.CochraneDatabaseofSystematicReviews2009,Issue3.Art.No.:CD006447.DOI:10.1002/14651858.CD006447.pub2. Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. ABSTRACT Background Inductionofgeneralanaesthesiacanbedistressingforchildren.Non-pharmacologicalmethodsforreducinganxietyandimproving co-operationmayavoidtheadverseeffectsofpreoperativesedation. Objectives Toassesstheeffectsofnon-pharmacologicalinterventionsinassistinginductionofanaesthesiainchildrenbyreducingtheiranxiety, distressorincreasingtheirco-operation. Searchstrategy WesearchedCENTRAL(TheCochraneLibrary2009,Issue1).Wesearchedthefollowingdatabasesfrominceptionto14thDecember 2008:MEDLINE,PsycINFO,CINAHL,DISSERTATIONABSTRACTS,WebofScienceandEMBASE. Selectioncriteria Weincludedrandomizedcontrolledtrialsofanon-pharmacologicalinterventionimplementedonthedayofsurgeryoranaesthesia. Datacollectionandanalysis Twoauthorsindependentlyextracteddataandassessedriskofbiasintrials. Mainresults We included 17 trials, all from developed countries, involving 1796 children, their parents or both. Eight trials assessed parental presence.Noneshowedsignificantdifferencesinanxietyorco-operationofchildrenduringinduction,exceptforonewhereparental presencewassignificantlylesseffectivethanmidazolaminreducingchildren’sanxietyatinduction.Sixtrialsassessedinterventionsfor children.Preparationwithacomputerpackageimprovedco-operationcomparedwithparentalpresence(onetrial).Childrenplaying hand-heldvideogamesbeforeinductionweresignificantlylessanxiousthancontrolsorpremedicatedchildren(onetrial).Compared withcontrols,clowndoctorsreducedanxietyinchildren(modifiedYalePreoperativeAnxietyScale(mYPAS):meandifference(MD) Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) 1 Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. 30.7595%CI15.14to46.36;onetrial).Inchildrenundergoinghypnosis,therewasanonsignificanttrendtowardsreducedanxiety duringinduction(mYPAS<24:riskratio(RR)0.5995%CI0.33to1.04-39%versus68%:onetrial)comparedwithmidazolam. Alowsensoryenvironmentimprovedchildren’sco-operationatinduction(RR0.66,95%CI0.45to0.95;onetrial)andnoeffecton children’sanxietywasfoundformusictherapy(onetrial). Parentalinterventionswereassessedinthreetrials.Childrenofparentshavingacupuncturecomparedwithparentalsham-acupuncture werelessanxiousduringinduction(mYPASMD17,95%CI3.49to30.51)andmorechildrenwereco-operative(RR0.63,95%CI 0.4to0.99).Parentalanxietywasalsosignificantlyreducedinthistrial.Intwotrials,avideoviewedpreoperativelydidnotshoweffects onchildorparentaloutcomes. Authors’conclusions Thisreviewshowsthatthepresenceofparentsduringinductionofgeneralanaesthesiadoesnotreducetheirchild’sanxiety.Promising non-pharmacologicalinterventionssuchasparentalacupuncture;clowndoctors;hypnotherapy;lowsensorystimulation;andhand- heldvideogamesneedstobeinvestigatedfurther. PLAIN LANGUAGE SUMMARY Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren Theinitial processofgiving generalanaesthesia(i.e.induction of anaesthesia)tochildren,canbe distressing forthemandalsofor their parents. Childrencan be given drugs to sedate themwhenanaesthesia is being induced, but these drugs can have unwanted harmfuleffects,suchaspossibleairwayobstructionandbehaviourchangesaftertheoperation.Somenon-drugalternativeshavebeen testedtoseeiftheycouldbeusedinsteadofsedativedrugswhenanaesthesiaisbeinginducedinchildren.Thepresenceofparentsat inductionofthechild’sanaesthesia,hasbeenthemostcommonlyinvestigated(eighttrials),buthasnotbeenshowntoreduceanxiety ordistressinchildren,orincreasetheirco-operationduringinductionofanaesthesia.Aninterventioncanbegiventoachildortoa parent.Onestudyofacupunctureforparentsfoundthattheparentwaslessanxious,andthechildwasmoreco-operative,atinduction ofanaesthesia.Anotherstudyofgiving parentsinformation, intheformofpamphletsorvideos, failedtoshowaneffect.Insingle studies,clowndoctors,aquietenvironment,videogamesandcomputerpackages(butnotmusictherapy)eachshowedbenefitssuch asimprovedco-operationinchildren.Thesepromisinginterventionsneedtobetestedinadditionaltrials. BACKGROUND 2005a;vandenBerg2005b).Inhalationalanaesthesiaisinduced Theinitialintroductionofageneralanaestheticisknownas“the withavolatileagentinairornitrousoxidemixedwithsupplemen- inductionofanaesthesia”andcanbedistressingforchildren.Dis- taloxygen,usuallythroughabreathingcircuit(tubingattachedto ruptedroutines,unfamiliarfaces,separationfromfamily,hospi- afacemask). talproceduresanduncertainty about anaesthesiaor surgery can Distressandanxietyinchildrenundergoinganaesthesia betraumaticforpatients(Brennan1994;Feldman1998).Min- imizing anxiety and distress at the time of anaesthetic induc- Mostchildrenfindinductionofgeneralanaesthesiabeforesurgery tionmayreduceadversepsychologicalandphysiologicaloutcomes verystressful(Kain2005;Wollin2003);andparentalstresscanbe (Greenberg1996;Holm-Knudsen1998). easilytransmittedindirectlytoachild(Bevan1990).Thelevelof achild’sanxietyvarieswithage,maturity,temperamentandpre- Inductionofanaesthesia viousanaestheticexperiences(Davidson2006;Stargatt2006).A General anaesthesia may be induced by inhaled or intravenous previouslyco-operativechildmaybecomeapprehensiveandresist routes,thoughtheformerismostoftenusedforchildren.Many theapplicationofthemaskontheirfaceorbecomeupsetwhenthe anaesthetistsbelievethatamaskorinhalationalinductionisless anaestheticcircuitisbroughtclosetothem.Childrenmayprotest, psychologicallytraumatictochildren(Aguilera2003),sincechil- fightortryandescapeduringthisperiod(Greenberg1996),which drenaregenerallythoughttohaveafearofneedles(vandenBerg mayprolongtheinductionandbeemotionallytraumaticforthe Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) 2 Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. child,parentsandtheatrestaff(Holm-Knudsen1998;Iacobucci OBJECTIVES 2005;Kain1999b).Preoperativedistressmaybeassociatedwith Toassesstheeffectsofnon-pharmacological interventionsinas- postoperativeagitation andnegativebehaviours(Stargatt2006). sisting induction of general anaesthesia in children by reducing Theconsequencesofpreoperativeanxietyanddistressmayextend theiranxiety,distressorincreasingtheirco-operation. beyondtheperioperativeperiod(Kain1996;Kotiniemi1997). Prosandconsofpremedication METHODS Sedativemedicationscanalleviatepreoperativeanxiety;facilitate separationfromrelativesorfriends;andreducedistressatinduc- tion (Kain 1999a). However, childrenmay refuse the drug, the Criteriaforconsideringstudiesforthisreview drugmayfailorevencauseparadoxicalreactionssuchasdisinhi- bitionanddysphoria,postoperativebehaviouralchangesandpro- longedrecoverytimes(Ullyot1999).Otherdrawbacksincludesa- Typesofstudies fetyconcerns(airwayobstructionorrespiratorydepressioninun- monitoredsituations);costsofpharmacy;additionalnursingstaff Weincludedrandomizedorquasi-randomizedcontrolledtrials. and equipment; list delays; and delayeddischarge (Cray 1996); andsonon-pharmacologicalmethodshavebeensought. Typesofparticipants Weincludedchildrenoradolescentsagedlessthan18yearspre- sentingforinductionofgeneralanaesthesia,exceptwherethein- Interventions tentissolelyintravenousinduction. A wide range of non-pharmacological interventions have been usedtoreduceperioperativedistressandencourageco-operation Typesofinterventions inchildren.Thesecanbebroadlycategorizedas: Weincludedanynon-pharmacologicalinterventionimplemented onthedayofsurgerycomparedwithanyotherintervention,such • psychological(cognitiveorbehavioural); asamidazolampremedication,ornotreatment.Studiesmayas- • environmental; sessasingleinterventionoracombinationofinterventions,and may compare them with other non-pharmacological interven- • equipmentmodification; tions;pharmacologicalinterventions(e.g.midazolamorketamine premedication);orwithusualcare. • socialinterventions,includingcommunication. Weincludedthefollowingtypesofinterventions: • psychological(cognitiveorbehavioural)interventions:such Rationaleforthereview asdistraction,cognitivetasks,hypnosis,virtualreality; • environmentalinterventions:useofinductionroom, Previoussystematicreviewshaveexaminedtheeffectsofpatient patientretainsownclothing; educationonpreoperativeanxiety(Lee2003;Lee2005)andthe • equipmentmodification:disguisedanaesthesiadelivery effect of preoperative fasting on perioperative complications in system; children (Brady 2005). A Cochrane review in progress (Prictor • socialinterventions:parentalorsupportpersonpresence, 2004) will address non-pharmacological interventions for chil- numberofmedicalstaffintheroomatinduction; drenandadolescentspriortohospitalization.ACochranereview • anaesthetistcommunication:toneofvoice,language (Uman2006)hasevaluatedpsychologicalinterventionsfornee- (neutralorpositive). dle-relatedproceduresinchildrenandadolescentswhichincludes patientspresentingforintravenousinductionofanaesthesia.Also Weconsideredinterventionswithparentsoraccompanyingper- PillaiRiddell2006hasinvestigatednonpharmacologicalinterven- sons if the child’s anxiety, distress or co-operation at induction tionsforneedle-relatedproceduralpaininneonatesandinfants. wereoutcomemeasures. Therehasbeennocomprehensive,systematicreviewoftheeffects ofnon-pharmacologicalinterventionsadministeredinhospitalto Typesofoutcomemeasures assisttheinductionofanaesthesiainchildren.Inaddition,infor- mationaboutwhichparticularinterventionsorcombinationsof interventions are most effective in this setting has not been as- Primaryoutcomes sessed. Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) 3 Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. 1. thenumberofchildrenwithdistressoranxiety,orthe (1995 to 14th December 2008), CINAHL (1982 to 14th De- extentofpresenceorabsenceofdistressoranxiety(asdefined cember 2008), DISSERTATION ABSTRACTS (1988 to 14th andmeasuredbytheauthorsofthestudy)duringinductionof December2008),andWebofScience(1990to14thDecember generalanaesthesia; 2008). 2. thenumberofchildrenwhoco-operate,ortheextentof WesearchedMEDLINEusingtheMeSHheadingsandtextwords presenceorabsenceofco-operation(asdefinedandmeasuredby shown in Appendix 1. We adapted this strategy for the other theauthorsofthestudy)duringinductionofgeneralanaesthesia. databasesasappropriate. Afterpilotingvarioussearchstrategies,welargelyomittedterms todescribethepossibleinterventions,sinceourpilotingrevealed Secondaryoutcomes thatsuchinterventionswerenotalwaysindexed,orindexedcon- 1. thenumberofcaregiverswithanxiety(asdefinedand sistently. measuredbytheauthorsofthestudy); WesearchedregistersofongoingtrialssuchastheMeta-Register 2. thetimetakenforanaestheticinduction; ofTrials(www.controlled-trials.com). 3. changefromplannedinhalationaltointravenous(iv) induction; 4. thenumberofpatientswithincreasedanaesthetic Searchingotherresources requirements; We locatedadditional referencesby searchingthe referenceand 5. riskofemergencedelirium; citation lists of relevantpapersand adjusted our searchstrategy 6. thenumberofpatientswithnegativebehaviouralchanges accordingly. (asdefinedandmeasuredbytheauthorsofthestudy)inthe Wesearchedforunpublishedstudiesanddissertationsforpossible immediatepostoperativeperiod(whilepatientisinrecovery)e.g. inclusioninthisreviewbycontactingresearchersthroughemail distressinrecovery; list-serverssuchasthePaediatricAnaesthesiaConference(PAC) 7. thenumberofpatientsco-operatingorwithoutdistresson list-server;theSocietyofPediatricPsychologylist-server;andby enteringtheroom,orarea,whereanaesthesiainductionistotake contactingexpertsandtrialiststhroughe-mailanddirectcommu- place(asdefinedandmeasuredbytheauthorsofthestudy); nication. 8. thenumberofpatientsorcaregiverssatisfiedwithcare(as Wedidnotlimitthesearchbylanguageorpublicationstatus. definedandmeasuredbytheauthorsofthestudy). Whenpresentedascontinuousvariables;outcomessuchasanxiety, distress and co-operation were analysed using mean differences Datacollectionandanalysis wherepossible. OutcomeMeasures Selectionofstudies Wedefinedtheseasanytypeofnegativeaffectorbehaviourasso- We reviewed the titles and abstracts of studies identified from ciatedwiththeinductionofanaesthesia(e.g.anxiety,stress,fear, thesearch.Fromthefulltextofpotentiallyrelevantarticles,two unco-operativebehaviour)whichcanbeassessedbypsychological authors(PY,AvC)independentlyassessedeachtrialforinclusionin measuresofbehaviour,anxietyordistresssuchastheYalePreoper- termsofpopulation,intervention,outcome,andstudydesign.We ativeAnxietyScaleformeasuringanxietyinyoungchildren(Kain resolveddisagreementsregardinginclusionofpotentiallyeligible 1997);theInductionComplianceChecklistforassessingco-op- studiesbyconsensusorthirdauthorarbitration(AMC). erationduringinduction(Kain1998);andtheVernonPostHos- Weexcludedstudies: pitalizationBehaviorQuestionnaire(Stargatt2006).Thesescales • wherepatientoutcomesrelevanttothisreviewwerenot mayprovideameasureoftheextentofanxietyordistress. measuredorreported; • ofprehospitalpreparationprogrammes(hospitaltours, Searchmethodsforidentificationofstudies modelling,stress-pointpreparation)whicharethesubjectofa Cochranereviewinprogress(Prictor2004); Electronicsearches • ofnon-hospitalsettings; WesearchedtheCochraneCentralRegisterofControlledTrials • ofpatienteducationormedia-basedinterventionspriorto (CENTRAL)(TheCochraneLibrary2009, Issue1).Wealsowe thedayofsurgerywhichhasbeenaddressedelsewhere(Lee searched the following complementary medicine, nursing, psy- 2003;Lee2005); chologyandmedicaldatabases:MEDLINE(1966to14thDecem- ber2008),EMBASE(1974to14thDecember2008),PsycINFO Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) 4 Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. • assessingtheeffectsofnon-pharmacologicalinterventions Wehadplannedtoconductsubgroupanalysestocompare: toassistwithintravenousinductionofanaesthesia,asthisis • differentagegroupssuchas:infantortoddler(0to2years), beingconsideredelsewhere(Uman2006;PillaiRiddell2006); children(3to12years)andadolescent(3to17years); • inhalationalandintravenousmethodsofinduction(for • assessingtheeffectsoffastingpreoperativelyasthisisbeing studieswherebothmethodshavebeenused); consideredelsewhere(Brady2005). • whethertheoutcomesweremeasuredatthetimeof induction,beforeinductionorafterinduction. Howevertherewereinsufficientdatatodothis. Dataextractionandmanagement We intended to perform the following sensitivity analyses, but Twoauthorsindependentlyextractedthefollowingdata(usinga againtherewereinsufficientdatatocompletethis: formdesignedforthisspecificreview): • forrandomizedandquasi-randomizedtrials; • studyparticipants:age,gender,previousanaesthetics, • fortrialswithandwithoutclearallocationconcealment; inclusionandexclusioncriteria; • intrialswhereanaestheticagentsatinductionarecontrolled andnotcontrolledfor. • studymethods:objective,design,randomization, recruitment,blinding(participant,assessor,otherstaff, Weattemptedtoassesspossiblepublicationbiasbyvisualinspec- statistician),methodsofanalysis,follow-up; tionoffunnelplots,withasymmetryofthefunnelplotsindicating • interventions:interventiontype,timing(whenintervention possiblepublicationbias. used),co-interventions,control(usualcaredescription); • outcomes:outcometype,author’sdefinitionofoutcome, measurementtool(includingvalidity),timingofassessment; • results:means,standarddeviations,numbersofevents, RESULTS proportions; • studywithdrawalsorlossestofollow-up,withreasons. Wecontactedonestudyauthortoclarifyinformationandprovide Descriptionofstudies additionaldata.Whenthedataextractionformswerecompleted, tworeviewauthors(PM,PY)enteredthedataintoReviewMan- See:Characteristicsofincludedstudies;Characteristicsofexcluded agersoftware(RevMan5.0)andthiswascheckedbyathirdreview studies. author(AVC). We included17 trialsand excludednine. Thereasons for these exclusionswerethatthreetrialswereofinterventionsappliedprior tothedayofsurgery;twodidnotclearlystatethatoutcomeswere Assessmentofriskofbiasinincludedstudies measuredatinduction;twoweretrialsinadults,onetrialtested Twoauthors(PY,AVC)independentlyexaminedthemethodolog- apharmacologicalinterventionandonetrialwasacomparisonof icalqualityoftrialsinrelationtorandomization;allocationcon- parentalpresenceatinductionwithparentalpresencebothatin- cealment;outcomeassessment;blindingofoutcomeassessments; ductionandatemergence(seeCharacteristicsofexcludedstudies). lossestofollow-upandtreatmentofwithdrawals.Wegradedeach Includedstudies itemas’adequate’,’inadequate’or’unclear’;orgaveactualnum- The17includedtrialsinvestigated13comparisonsinvolving1796 bersinthecaseoflossestofollow-up.Duetothenature ofthe childrenortheirparents.SeeCharacteristicsofincludedstudies interventions,suchasparentalpresence,blindingoftheinterven- fordetaileddescriptions. tions was not possible. Therefore, we included studies without Settings blindingofindividualsadministeringandreceivinginterventions ElevenofthetrialswereconductedintheUnitedStatesofAmerica; forinclusion. threewereconductedinEurope;twowereconductedintheUK andonewasconductedinJapan. Interventions Datasynthesis Weincludedeighttrialsofparentalpresence;andsixchildinter- We synthesized and analysed data using RevMan 5.0. In stud- ventiontrialsandthreeparentalinterventiontrials: iesthatreporteddichotomousdata,wecalculatedriskratioswith Parentalpresence 95% confidence intervals (CI). For continuous outcomes (such • parentalpresenceversusnoparentalpresence(Arai2007; asanxiety)wecalculatedmeandifferences(MD)and95%confi- Bevan1990;Kain1996;Kain1998;Kain2000;Kain2003; denceintervals.WeestimatedheterogeneityusingtheI2 statistic Kain2007;Palermo2000); (Higgins 2002). Where there was moderate heterogeneity (I2 > • parentalpresenceversusmidazolam(Arai2007;Kain1998; 50%)wepresenteddatawitharandom-effectsmodel. Kain2007); Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) 5 Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. • parentalpresenceversusparentalpresenceplusmidazolam Dataonimmediatepostoperativebehaviouralchangesinchildren (Kain2003). weredescribedinthreestudiesemployingtwodifferentscales:ex- citement scale (Kain 1996; Kain 2000) and the emergence be- Childinterventions haviourscale(Kain2007).Otherscollecteddataonbehavioural • cartoonandinteractivecomputerpackagepreparation changesbeyonddayonefrompost-hospitalbehaviouralquestion- (Campbell2005); naires.Parentalsatisfactionwasmeasuredbya100mmvisualana- • videogames(Patel2006); logue scale (Kain 1996) and Likert scales (Kain 1998; Palermo • clowndoctors(Vagnoli2005); 2000). • hypnosis(Calipel2005); Dataonotheroutcomesofinterestcollectedwere:riskofadverse • lowsensorystimulation(Kain2001); effects;timetodischarge;andanalgesiarequirements. • musictherapy(Kain2004). Parentinterventions • parentalacupuncture(Wang2004); • parentalvideo(McEwen2007;Zuwala2001). Riskofbiasinincludedstudies Sometrialsinwhichparentalpresencewasnottheprimaryfocus of theintervention, controlledfor thisfactor by having parents present (Campbell 2005; McEwen 2007; Patel 2006; Vagnoli Randomization 2005; Wang 2004; Wang 2005; Zuwala 2001); or not present (Kain 2004; Kain 2001; Wang 2008) during the induction of anaesthesia.Onetrialdidnotcontrolforparentalpresence(Calipel 2005)andonetrialusedparentsasarescueinterventionforanxiety Sequencegeneration inthecontrolgroup(Kain2003). Participants Mosttrials(n=9)usedcomputer-generatedrandomization;five Theincludedtrialsinvestigatedchildrenagedupto17yearsand did not reporttheir methodof sequence generation; threeused downto10months(inZuwala2001).MosttrialsexcludedASA randomnumbertables;oneusedpermutedblocks;andonetrial III&IVchildrenandthosewithahistoryofchronicillness,pre- wasquasi-randomized,usingdaysoftheweek(Bevan1990). maturityanddevelopmentaldelay.Fourtrialsexcludedchildren whohadreceivedprevious surgery (Arai2007;Campbell2005; Kain1996;Zuwala2001).Calipel2005excludedthosewhohad Allocationconcealment beenhospitalizedsixmonthspriortothestudy.Mostreceivedin- halationalanaesthesiawithoxygen,nitrousoxideandsevoflurane. Notrialcouldbeclassifiedashavingreportedadequateallocation Halothanewasusedintwostudies(Kain1996;Kain1998).Three concealment.Mosttrials(n=14)didnotreportthemethodof trials failed to describe the induction technique (Bevan 1990; allocationconcealmentandtwotrialsusedsealedenvelopes,and McEwen2007;Palermo2000). so16ofthe17trialswereratedashavingunclearallocationcon- Outcomeassessments cealment.Bevan1990hadinadequateallocationconcealment,as VersionsoftheYalePreoperativeAnxietyScale(YPAS,mYPAS) daysoftheweekswereusedtoallocateparticipantstogroups. were used by most studies to assess anxiety of children. Other scalesusedwere:hospitalfearinventory;globalmoodscale;visual analoguescale;clinicalanxietyratingscale;proceduralbehavioural Blinding rating scale;; and the child behaviour scale. Serum cortisol was measuredbyonestudyasaphysiologicalindicator foranxiety( Blindingwasnotalwayspossiblebecausemostinterventionswere Kain1996).Complianceofchildrenwasratedusingtheinduction visibletoinvestigatorsandparticipants.Fourtrialsreportedthat compliancechecklist(ICC)infivetrials(Kain1998;Kain2000; assessments of outcomes were blinded and the rest of the trials Kain2001;Kain2004;Wang2004). either had partial or no blinding; or they did not describe any Parental anxiety was assessed using state trait anxiety inventory methodsofblinding. (STAI)inmoststudies.Othermethodsofassessmentwere:anx- ietyvisual analogue scale(VAS);anxietyquestionnaire; monitor blunterstylescale(MBSS);andtheAmsterdamPreoperativeAnx- Lossestofollow-up ietyandInformationScale(APAIS).Inthreestudies(Kain1996; Kain2003;Zuwala2001)bloodpressure,heartrate,skinconduc- Losses to follow up were generally small, as would be expected tanceweremeasuredasphysiologicalindicatorsofparentalanxi- wheremostoutcomeswereabletobeassessedsoonafterthein- ety. tervention. Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) 6 Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd. Effectsofinterventions 1.3Parentalpresenceversusparentalpresenceplus midazolam(comparison3) Childrenweresignificantlylessanxiousduringinductionifthey 1.Parentalpresence receivedmidazolamaspremedicationandwereaccompaniedby Eighttrialsinvestigatedtheusefulnessofparentalpresenceinreduc- theirparents,comparedwithparentalpresencealone;P=0.023 ingdistressassociated withinduction inchildreninseveraltypes of (nofurtherdetailsreported)(Kain2003)(Analysis3.1;Analysis comparisons(Arai2007;Bevan1990;Kain1996;Kain1998;Kain 3.2).However,theadditionofpremedicationforthechildhadno 2000;Kain2003;Kain2007;Palermo2000). impactonparentalanxiety. 1.1Parentalpresenceversusnoparentalpresence 2.Childinterventions (comparison1) Sevendifferentinterventionsforchildrenundergoinganaesthesiawere Noneofthestudiesshowedanydifferenceinanxietyorcoopera- assessedinsixtrials. tionofchildrenonenteringtheinductionareaorduringinduc- tion (Bevan 1990;Kain 1996; Kain 1998; Kain2007; Palermo 2.1Cartoonandinteractivecomputerpackagepreparation 2000)(Analysis1.2;Analysis1.4) (comparisons4,5and6) Kain2003alsoreportednosignificantdifferenceinchildren’sanx- iety between parental presence or no parental presence, but no Preparation with interactive computer packages (in addition to furtherdetailsweregiven.Inasubgroupof49anxiousparentsin parentalpresence)wasmoreeffectiveinmakingchildrenmoreco- onetrial(Bevan1990),childrenof’anxious’parentsweresignifi- operativeduringinductioncomparedtoparentalpresencealone cantlymoreupsetbyhavingaparentpresentatinductionthanif (Campbell2005).Childrenwhowerepreparedbyinteractivecom- theywereseparatedasmeasuredbytheGlobalMoodScale(GMS) puterpackageorwithcartoonsshowedsimilarlevelsofcoopera- (meandifference1.1095%CI0.26to1.94). tionatinduction,butthecomputerpreparedgroupshowedfewer Parental presence had no significant effects overall on parental negativebehaviouralchangesintherecoveryareacomparedwith anxiety (Analysis 1.7) or satisfaction (Analysis 1.15); children’s thecartoongroup. cooperationduringinduction;emergencedelirium(Analysis1.9); ortimetakenforinduction(Analysis1.11);ornegativebehaviour 2.2Videogames(comparisons7and8) postoperativelyafterdischarge(atoneweek;twoweeks;andsix months)(Analysis1.12). Childreninthevideogamegroupweresignificantlylessanxious Inonetrial,whenallchildrenwerepremedicatedwithmidazolam, thanthoseinthecontrolgroup(Patel2006; mYPASMD-9.8, parents were significantly less anxious and more satisfied when 95%CI-19.42to-0.18;n=74;Analysis7.1);andalsocompared theywerepresentduringinduction(Kain2000)comparedwith withthechildrenwhowerepremedicatedwithmidazolam(mY- thoseparentsnotpresent.Inanothertrialwithallchildrenpre- PASMD-12.2,95%CI-21.82to-2.58;n=76).Nodifferences medicatedwithmidazolam,neitherthequalityofmaskinduction inpostoperativebehaviourscoreswereseen,comparedwitheither nor emergencebehaviours wasimprovedwhenthemotherheld controlsorthemidazolamgroup. herchildcomparedwithinductionwithoutaparentpresent(Arai 2007). 2.3Clowndoctors(comparison9) Clown doctors significantly reduced children’s anxiety (mYPAS 1.2Parentalpresenceversusmidazolam(comparison2) MD30.7595%CI15.14to46.36;40children;Analysis9.1)but Midazolamwassuperiorinreducinganxietyofchildrenduringin- hadnoapparenteffectonparentalanxiety(STAIMD4.75,95% ductioncomparedwithparentalpresence-MD10pointsmYPAS CI-9.05to18.55;Analysis9.2)comparedwithparentalpresence 95%CI2.91to17.09(Kain2007)andcooperation(Kain1998) (Vagnoli2005). (Analysis2.1;Analysis2.2).Italsoshortenedthetimetakenfor inductionby0.6minutes(95%CI0.36minutesto0.84minutes) inonetrialof62children(Kain1998)(Analysis2.5).Therewere 2.4Hypnosis(comparison10) nosignificantdifferencesinparentalanxiety,parentalsatisfaction, Compared with midazolam premedication, fewer children were emergence delirium in the recovery area or negative behaviour anxious (mYPAS > 24) during induction of anaesthesia in the twoweekspostoperatively.Inanothertrial,midazolamwassignif- hypnotherapy group but this did not reach statistical signifi- icantlybetterthanparentalpresencealoneinqualityofthemask cance(RR0.5995%CI0.33to1.04;50children,Calipel2005; induction, but no difference was seen for emergence behaviour Analysis10.1).Significantlyfewerchildrendemonstratednegative (Arai2007). behaviourpostoperativelyinthehypnotherapygroup(duringday Non-pharmacologicalinterventionsforassistingtheinductionofanaesthesiainchildren(Review) 7 Copyright©2010TheCochraneCollaboration.PublishedbyJohnWiley&Sons,Ltd.
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