Current Rapid Tranquillisation Documents in the UK

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Review Article

Current rapid tranquillisation documents in the UK: a review of thedrugs recommended, their routes of administration and clinical

parameters influencing their use

James Innes1, Faisil Sethi2

1Deputy Chief Pharmacist, East London NHS Foundation Trust, UK; 2Consultant Psychiatrist, South Londonand Maudsley NHS Foundation Trust, UK

Abstract

Background: Despite not being underpinned by a strong evidence base, rapid tranquillisation is frequently theintervention of choice for dealing with violent and aggressive behaviour in psychiatric hospitals. This is the secondof a two-part review of recommendations set out in UK trusts adult rapid tranquillisation documents. In this articlewe focus on the drugs recommended, their routes of administration and clinical parameters influencing their use.

Method: A review of adult rapid tranquillisation documents currently in use in NHS or HSC trusts providingadult mental health services in the UK.

Results: A total of 45 rapid tranquillisation documents met the inclusion criteria and were examined. Sixteendrugs were recommended, via four separate routes of administration. Beyond the use of oral and IM lorazepam,haloperidol and olanzapine there was no consensus as to which drugs should be used for rapid tranquillisationin adults. Eleven clinical decision-making parameters were identified that influenced the selection of drugs for

IM administration. However, the wide variation and sometimes absence of advice surrounding these parameterswas concerning.

Conclusions and implications for clinical practice: The results of this review demonstrate that there is aneed to rationalise rapid tranquillisation and develop consensus guidelines that allow for evidence baseddecision-making tools.

Keywords

Rapid tranquillisation; drugs; route; review

INTRODUCTION

A number of clinical interventions may beused to safely manage violent and aggressive

behaviour. These may include de-escalation,rapid tranquillisation (RT), control and restraint,and seclusion (supervised confinement). Follow-ing unsuccessful de-escalation, RT (the use ofmedication to rapidly calm the severely agitatedor aggressive patient) is recommended as the nextintervention.

Correspondence to: James Innes, East London NHS Foundation Trust,Pharmacy Department, Mile End Hospital, Bancroft Rd, London E14DG. E-mail: [email protected] published online 19 November 2012

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Journal of PsychiatricIntensive Care

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RT is not underpinned by a strong evidencebase. This is partly due to the ethical issuesassociated with recruiting patients to clinical trials,but also because of a general lack of internationalconsensus regarding the therapeutic aims of thisintervention. For example, the highly regardedTREC studies that were undertaken in India andBrazil used a primary outcome of the patientbeing either tranquil or asleep (Raveendran et al.2007; Huf et al. 2007). This is contrary to theUK based definition of RT, which emphasisesthat the patient should remain conscious through-out and be able to comprehend and respond tospoken messages (National Institute of ClinicalExcellence, 2005).

There are often high expectations placed onthe medicines being selected for RT. The idealdrug should act rapidly, be effective, safe andconsidering the current politico-economic cli-mate, be cost effective. Few, if any, drugscompletely meet all of these criteria, althoughsome are better suited to RT than others.

All service providers should have in placedocuments that cover the use of RTwithin theirorganisations (National Institute of ClinicalExcellence, 2005). This is the second of a two-part review examining practice recommendationsset out in adult RT documents from trustsproviding mental health services in the UK. Thefirst of these (Innes & Iyeke, 2011) focussed onthe practice of post-RT monitoring. A picture ofwide ranging practice was observed and con-cerning variation identified in what was only onecomponent of the overall RT process. Thissecond article focuses on the drugs, routes andclinical decision-making information influencingtheir selection and use in RT.

AIM

To identify the drugs recommended, theirroutes of administration and clinical parametersinfluencing their use for RT in adult patientsacross the UK.

METHOD

Sixty-eight National Health Service (NHS) orHealth and Social Care (HSC) trusts providing

adult mental health services in the UK wereoriginally contacted between July and August2010, with a request for copies of their adult RTdocuments. All mental health trusts in Englandwere contacted together with those trustsidentified by a search strategy for NorthernIreland, Scotland and Wales. Those trusts thatresponded were re-contacted between Februaryand March 2012 to ascertain whether thedocuments obtained in 2010 were still in useand if not to request updates.

RT documents included policies, guidelines,protocols, procedures, standard operating pro-cedures and algorithms. All were given equalweighting and consideration in this review.

Inclusion and exclusion criteria

Only NHS or HSC Trust adult RT documentsconfirmed to be in current use, or within theirspecified review date were included in this review.

Data analysis

Data was extracted by a single reviewer andevidence tables compiled. All data presentedwere anonymised.

RESULTS

A total of 45 NHS or HSC RT documents metthe inclusion criteria for this review. Of these,38 originated from England, one from NorthernIreland, four from Scotland and two from Wales.Forty-two documents were confirmed to bein current use with another three within theirspecified review date.

Drugs recommended for use in RT and

their respective routes

In total, 16 drugs were recommended foruse in RT, via four separate routes of adminis-tration: oral, buccal, intramuscular (IM) andintravenous (IV).

The oral route featured in 41 of the 45 docu-ments and a total of 12 drugs was recom-mended for use. Figure 1 clearly shows that four

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drugs were recommended most frequentlyin descending order: lorazepam, haloperidol,olanzapine and risperidone.

The IM route featured in all documentsexamined and a total of ten drugs wererecommended for use. Figure 2 shows that threedrugs were recommended most frequently:lorazepam, olanzapine and haloperidol. Whilstzuclopenthixol acetate also featured frequently,24 of 32 documents went on to recommend thatits use was inappropriate for RT.

The IV route featured in 19 documents and atotal of three drugs were recommended for use.Diazepam was recommended in 13 documents,lorazepam in another two, with two furtherdocuments recommending that benzodiaze-pines be used. The antipsychotic haloperidolfeatured in seven documents.

The buccal route featured in two RTdocuments with midazolam being the only drugrecommended.

Clinical parameters influencing the use of

drugs for RT

Clinical decision-making information influen-cing the selection of drugs for RTwas present innearly all documents examined (n5 44). Toenable the reviewer to identify clinical decision-making themes across all RT documents, furtheranalysis was confined to the IM route only, asthis applied to all those examined. Regularlyoccurring clinical decision-making parametersinfluencing the selection of drugs for RT wereidentified and examined. Figure 3 illustrates

these and their frequency.

Compatibility with current treatment (n544)This was the most common clinical decision-making parameter appearing in nearly all RTdocuments. The recommendation that IMolanzapine and IM benzodiazepines should notbe administered within an hour of each otherproved the most consistent, appearing in 32documents. Another document recommendedthe same but with a time interval of two hoursand another eight that concurrent administration

of IM olanzapine and IM benzodiazepines shouldsimply be avoided. Fifteen documents recom-mended that other prescribed medications shouldbe considered when selecting medicines for RT,with another six recommending specific care inthose already prescribed medicines that couldFigure 1. Drugs recommended for oral use in RT

Figure 2. Drugs recommended for IM use in RT

Figure 3. Clinical decision-making parameters influencing IM drug

selection in RT

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prolong the QT interval. Six documents recom-mended lorazepam alone in patients alreadyestablished on antipsychotics; another threerecommending this only if the patient wasestablished on high dose antipsychotics, withanother recommending lorazepam with or with-out an antipsychotic. In those already receivingbenzodiazepines, three documents recommendedthe use of antipsychotics, another three haloper-idol and another promethazine. Finally, onedocument recommended that the dose oflorazepam should be reduced by 50% when thepatient was being treated with valproate.

Use of IM haloperidol (n5 36)A variety of instructions and guidance was givenbut there was no consistent pattern. Threedocuments recommended haloperidol in thosealready receiving benzodiazepines, another tworecommended that it be used in severe cases andanother in those intoxicated with illicit drugs.In contrast, five documents recommended thathaloperidol was a last choice drug, with afurther nine recommending that it shouldonly be used after a pre-treatment ECG. Eightdocuments recommended that it should beavoided altogether in neuroleptic nave patients,another that lower doses should be used in suchcases and six that it should be avoided in thosewith a history of severe extra pyramidal sideeffects (EPSEs). Finally, one document statedthat it should be avoided in those with anunknown response to haloperidol. Seven docu-ments that recommended IM haloperidol didnot give any additional or safety guidance aboutits use.

Safe use of IM benzodiazepines (n529)Fifteen documents stated that benzodiazepinesshould be avoided in patients with respiratoryimpairment or disease. Seven documents stated

that they should be avoided in those who werebenzodiazepine tolerant, with three stating thatthey should be avoided in those with benzo-diazepine hypersensitivity. One document statedthat they should be avoided in those who arephysically unwell or delirious and two that theyshould be avoided in those patients who hadpreviously experienced disinhibition with ben-zodiazepines. Finally, one document recom-mended that they should be avoided in those

intoxicated with alcohol or sedatives. Fifteendocuments that recommended IM benzodiaze-pines gave no specific guidance on their safe usein RT.

Patients mental state (n5 28)A range of instructions was given regardingmental state. There was no consistent pattern.Twelve documents recommended that in a non-psychotic context benzodiazepines, or specificallylorazepam, should be used alone. In a psychoticcontext, lorazepam monotherapy was recom-mended as first line in two documents whilstseven recommended an antipsychotic with orwithout benzodiazepines. In moderate distur-bances two documents recommended the use ofolanzapine. In severe disturbances one documentrecommended a combination of haloperidol andlorazepam and another two recommended halo-peridol monotherapy. Finally, one documentstated that a combination of aripiprazole andlorazepam should be used in an emotionallydominated crisis and olanzapine should be used ina behaviourally dominated crisis. Seventeendocuments gave no guidance on how mentalstate should influence the choice of agent usedfor RT.

Use of medication in neuroleptic na vety (n5 27)Fourteen documents recommended benzodia-zepines or specifically lorazepam should be usedfirst line in patients who were neuroleptic nave.Two documents recommended that antipsycho-tics should be avoided; a further eight recom-mending that haloperidol be avoided, whilst onerecommended that lower doses of haloperidolshould be used. Finally, one document recom-mended that antipsychotics should be usedwith caution, with another recommending thatolanzapine was the preferred antipsychotic inthose who were neuroleptic nave. Eighteen

documents made no mention of tailoringtreatment in neuroleptic nave patients.

Patients with cardiovascular disease (n5 20)In those with cardiovascular disease, 15 docu-ments recommended benzodiazepines or speci-fically lorazepam should be used alone, withanother recommending that antipsychotic dosesshould be reduced. A further four documentsrecommended that antipsychotics should be


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avoided in patients with compromised cardio-vascular function. Twenty-five documents madeno reference to tailoring RT treatment in thosewith cardiovascular disease.

Extrapyramidal side effects or EPSEs (n5 15)Whilst EPSEs featured heavily in RT docu-ments as a treatment emergent side effect, only15 included a presence or history of EPSEs as aclinical parameter influencing RT drug selec-tion. Three documents recommended thatlorazepam should be used first line in patientswith EPSEs, seven recommended haloperidolbe avoided and another recommended anti-psychotics be avoided all together. Threedocuments recommended that olanzapine beused as an alternative to other antipsychotics inthose with a history of EPSEs. Finally, onedocument recommended checking whether thepatient had a history of EPSEs before prescrib-ing any medicines for RT. Thirty documentsmade no mention of tailoring treatment inpatients with a presence or history of EPSEs.

RT in pregnant patients (n5 14)Only seven of 45 documents contained aseparate section regarding the use of RT inpregnancy. Of these seven documents, fourrecommended the selection of a psychotropicwith a short half-life and also advised that theminimum effective dose be used. One docu-ment recommended avoiding lorazepam in thefirst and third trimesters owing to reports offoetal damage and to avoid haloperidol in thefirst trimester owing to reported teratogeniceffects. The remaining two made no specificrecommendations regarding drug selection. Sixother documents recommended that zuclo-penthixol acetate should not be used, whilstone document actively recommended thatlorazepam should be used first line in those

who were pregnant.

Impact of concurrent illicit drugs (n5 6)Information regarding the impact of illicit drugson medicines for RT was not frequentlyaddressed and when it was, guidance wasextremely varied. One document recommendedthat if a patient had been on illicit drugs thenan antipsychotic alone could be used, whilsttwo became more specific in this situation

recommending that olanzapine or haloperidolshould be considered. In contrast, three docu-ments stated that lorazepam should be used asmonotherapy in this situation.

History of neuroleptic malignant syndrome or NMS(n5 5)Whilst NMS featured heavily in RT documentsas a rare consequence of RT, only five includeda previous history as a clinical parameterinfluencing RT drug selection. Three docu-ments stated that lorazepam should be used inthose with a history of NMS, with anotherstating that antipsychotics should be avoided.Another stated that a history of NMS should bechecked before prescribing medication for RT.

Impact of concurrent alcohol use (n5

4)This scenario was only addressed in four docu-ments. One document stated that benzodiaze-pines should be avoided in patients intoxicatedwith alcohol, whilst another opposed this,recommending that lorazepam should be usedfirst line. One document stated that antipsychoticsshould be avoided if the patient exhibited signs ofalcohol withdrawal, with another stating thatantipsychotics should be avoided if the patient wasintoxicated.

DISCUSSION

Virtually all RT documents included oralpsychotropic prescribing as part of the RTpathway, complying with National Institute forClinical Excellence (2005) guidelines. This isencouraging as it reinforces the concept that RTis a process that begins well before the need forparenteral psychotropics arises. Whilst lorazepam,haloperidol, olanzapine and risperidone stoodout as the most commonly recommended oral

psychotropics, beyond this there was considerablevariation.

The IM medications recommended in RTdocuments make much more interesting read-ing. Whilst nearly all recommended lorazepam,olanzapine and haloperidol, other drugs are nowbeing recommended as a result of clinical issuesthat have arisen with some of these historicalgold standard drugs.

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The first of these clinical issues is the currentnational shortage of parenteral lorazepam.Clinicians are being forced to consider alter-natives, and many trusts have issued interimguidance or amended their RT documents toreflect possible alternatives. Some have recom-mended IM midazolam or promethazine whilstothers have managed to source and importunlicensed lorazepam from other countries suchas the USA.

As stated above, the IM benzodiazepinemidazolam is in some places seen as an alternativeto lorazepam and its usage appears to be on theincrease. Whilst it is supported by some clinicalevidence (TREC Collaborative Group, 2003),the use of IM midazolam in RT is an unlicensedindication. It should also be noted that mid-azolam and lorazepam have different pharmaco-kinetics, with the former being much faster in itsaction. Compared to IM lorazepam there is ahigher risk of respiratory depression, and thiscombined with the lack of experience mostpsychiatric doctors have with it means many arehesitant about using it.

The issue has also been considered by theCare Quality Commission (unpub. newsletter:Mental Health Operations Newsletter for Commis-

sioners and Second Opinion Appointed Doctors(SOADs), June 2011):

Given this risk profile, CQC suggests toSOADs that they be especially mindful ofmidazolams licensed indications, and ofthe potential harm that may result post-administration. If certification is beingconsidered, they are likely to wish to satisfythemselves that the provider clinicians arefully aware of the risks, have adequatetraining in, and equipment for, resuscitation,

and that the risks are outweighed by suchclear benefits not obtainable from a moremainstream preparation that they can besatisfied that usage is defensible and is thatwhich a reasonable body of medical opinionskilled in mental health, not emergencymedicine, would view as appropriate.

This, together with a National Patient SafetyAgency Rapid Response Alert to reduce the

risk of midazolam injection overdoses (NPSA,2008), puts a clear imperative on organisationsthat advocate its use. Clinicians (doctors, nursesand pharmacists) must have the necessaryknowledge, skills and competencies surroundingits use including clinical sequalae and the use ofthe antidote flumazenil.

A significant number of trusts are now usingIM promethazine, which is a sedating antihis-tamine. In some places it is suggested as useful inthe benzodiazepine-tolerant patient (Taylor et al.2012), which may well propagate the beliefthat it is an alternative when IM lorazepam isunavailable or IM midazolam is an undesirableoption. Like midazolam, promethazine is pos-sibly not used widely enough for manypsychiatric doctors to be aware of its properties,although its use is backed up by substantialclinical evidence (TREC Collaborative Group,2003; Alexander et al. 2004; Huf et al. 2007;Raveendran et al. 2007).

The recommendation for a pre-treatmentECG by the manufacturers of haloperidol haspresented another clinical challenge to trusts(Janssen-Cilag Ltd, 2011). In spite of thisrecommendation, virtually all trusts still includehaloperidol in their RT documents, with onlynine recommending it should be used after anECG. An important point to note is that theNational Institute for Clinical Excellence recom-mend that all inpatients should have a pre-treatment ECG regardless of what antipsychoticthey are prescribed (National Institute for ClinicalExcellence, 2009). Inclusion of haloperidol in theRT document is not necessarily a true reflectionof how often it is used though. It seems to beheavily restricted in its use and has the secondlargest number of clinical decision-making para-meters allied to it. It will be interesting to see

how such recommendations change in thecoming years and whether it is superseded inclinical hierarchy by other IM options.

IM olanzapine is now more common thanhaloperidol in the RT documents used in thisreview. The primary drawback in the RTscenario is the fact that IM benzodiazepinescannot be given within one hour of IMolanzapine due to serious concerns around safety


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(Eli Lilly & Co. Ltd, 2012). This proved to be thelargest and most consistent clinical decision-making parameter that was identified, withinformation surrounding this recommendationfeaturing in 41 of 44 documents. Almost a thirdof documents included IM aripiprazole, which isregarded as safe when given concurrently withIM benzodiazepines, but as yet doesnt have thecumulative clinical experience of IM olanzapine.

The medium-acting IM antipsychotic zuclo-penthixol acetate (Clopixol Acuphase) featuredheavily in the RT documents reviewed. However,three quarters of documents that included it thenwent on to say that it should not be used in RT.The sedative effects of zuclopenthixol acetatebegin after about two hours, peak after about12 hours and can last for up to 72 hours. As such,it has no function in the process of RT, insteadhaving a role to play in the management of seriouschallenging behaviour in a psychotic patient whohas required repeated injections of antipsychoticsand/or sedatives. It is understandable that manytrusts have used their RT documents to informclinicians that this drug is unsuitable for RT,although it is concerning that 12 trusts stillrecommended it as a treatment option.

The IV route featured in less than half the

documents examined. This is hardly surprisinggiven the cardiovascular and respiratory risksassociated with both IV haloperidol and IVbenzodiazepines respectively. The medical risksare probably exacerbated by the challenges ofadministering IV medications to the active,struggling and restrained patient. It was inter-esting to see that IV benzodiazepines wereclearly more popular than IV haloperidol,possibly because the use of haloperidol via thisroute is no longer licensed (Janssen-Cilag Ltd,2011). Anecdotal evidence suggests that the IV

route in RT is used extremely rarely.

The buccal route only featured in twodocuments with midazolam the only drugrecommended. Some clinical evidence existsto suggest it may be suitable as a treatmentoption for RT (Taylor et al. 2008). However, itsuse in RT is unlicensed and would be subject tothe same limitations as the oral route with regardto when it could be administered.

Owing to the complexity of the data wechose to restrict the analysis of clinical decision-making parameters to the IM route. Theexamination of these offers a clear picture ofwhat trusts consider to be important whenprescribing in an RT scenario. In general therewere three types of parameters:

1. Parameters related to specific medications,classes of medication or medication sideeffects.

2. Parameters related to past/current psychiatricdiagnoses and treatment.

3. Parameters related to comorbid medicaldisorders and other health states.

The clinical decision-making parameters ineach document are very much dependent on themedications recommended and the type of RTdocument.

The results of this review have highlightedtwo concerning issues. The first is the widevariation in advice across different RT docu-ments within the same clinical decision-makingparameters; in a small number of cases the adviceis even conflicting, for example regarding illicitdrug and alcohol use. This leads one to wonderat the existence or rigour of the underlyingevidence base for the guidance offered in theseareas. The second is the lack of what shouldsurely be essential clinical decision-makingparameters in all RT documents. Examples ofthese include a history of NMS, which wasmissing from 40 documents, a presence orhistory of EPSEs which was missing from 30documents and neuroleptic navety which wasmissing from 18 documents. RT is a situation inwhich patients will often become exposed tohigher doses of parenteral psychotropic drugs.This information is surely essential to ensure that

the patient has the best and safest outcome.

What this review has shown is that RTdecision-making tools contained within RTdocuments are complex. A generic RT decision-making tool may look like Figure 4.

This review has a number of limitations. Thefirst is that all types of RT document were givenequal weighting and consideration, regardless of

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their classification. The implications of this aresignificant because only policies can dictate thepractice that must occur, whereas guidelines andother documents of an equivalent standing leaveroom for clinical discretion. Hence this reviewpoints towards the trends suggested by RTdocuments, it does not offer a definitive pictureof actual clinical practice. A second limitation isthat all data was extracted by a single reviewer.Whilst this is not unusual for this type of study,it must be acknowledged given the subjectivenature of extracting data from documents,especially in relation to clinical decision-makingparameters. A third limitation is that analysis ofclinical decision-making parameters was limitedto the IM route only. Whilst this provided theonly available method for comparing all docu-ments, it does mean that any clinical decision-making advice applying specifically to otherroutes would not have been included.

CONCLUSIONS

Practice in this area of psychiatric prescribingmay well be changing. At the point of thisreview, the majority of trusts did include oralmedication as part of the RT process, complyingwith National Institute for Clinical Excellence(2005) guidelines; only ten percent movedstraight to parenteral medication.

Many of the drugs used in RT havelimitations or relative restrictions on their use.

The limitations arise from a number of areasincluding licence, supply, interactions, sideeffects, pharmacokinetics and a lack of firmevidence base. Clinical practice is now subjectto more external scrutiny than ever before, andmany trusts now need to provide assurance thatRT is being used in clinically appropriatescenarios and subsequent monitoring takes placepost RT.

With the exception of lorazepam, haloperidoland olanzapine, this review shows that thereis no consensus over what drugs shouldbe included in an RT decision-making tool.There is a wide variation in advice acrossdifferent RT documents within the sameclinical decision-making parameters and in asmall number of cases the advice is evenconflicting. In some documents essential clinicaldecision-making parameters would also appearto be completely missing. These findings areconcerning.

RT is a high-risk clinical intervention andit generates all sorts of reactions from patientsand clinicians, as it is often used in associationwith physical restraint. It is virtually impossibleto have a one-size-fits-all algorithm for themanagement of such a diverse range of clinicalscenarios. The challenge to academics andclinicians is to rationalise RT, develop consensusguidelines that allow for evidence-based decision-making tools. We hope this review will act as acatalyst in this respect.

Figure 4. An example of a generic RT decision-making tool


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Current Rapid Tranquillisation Documents in the UK

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