When giving a medication using the track method you need to pull the skin to the side before inserting the needle?

Version 3. F1000Res. 2014; 3: 157.

Yasir Sepah,a,1,2 Lubna Samad,b,1,3 Arshad Altaf,4,5 Muhammad Sohail Halim,2 Nithya Rajagopalan,6 and Aamir Javed Khan1,3

Version Changes

Revised. Amendments from Version 2

Typos identified during the review process have been corrected and conclusion section has been updated to reflect the content of the manuscript.

Abstract

Aspiration during any kind of injection is meant to ensure that the needle tip is at the desired location during this blind procedure. While aspiration appears to be a simple procedure, it has generated a lot of controversy concerning the perceived benefits and indications. Advocates and opponents of aspiration both make logically sound claims. However, due to scarcity of available data, there is no evidence that this procedure is truly beneficial or unwarranted. Keeping in view the huge number of injections given worldwide, it is important that we draw attention to key questions regarding aspiration that, up till now, remain unanswered. In this review, we have attempted to gather and present literature on aspiration both from published and non-published sources in order to provide not only an exhaustive review of the subject, but also a starting point for further studies on more specific areas requiring clarification. A literature review was conducted using the US National Institute of Health’s PubMed service [including Medline], Google Scholar and Scopus. Guidelines provided by the World Health Organization, Safe Injection Global Network, International Council of Nursing, Center for Disease Control, US Federal Drug Agency, UK National Health Services, British Medical Association, Europe Nursing and Midwifery Council, Public Health Agency Canada, Pakistan Medical Association and International Organization of Standardization recommendations 7886 parts 1-4 for sterile hypodermics were reviewed for relevant information. In addition, curricula of several medical/nursing schools from India, Nigeria and Pakistan, the US pharmacopeia Data from the WHO Program for International Drug Monitoring network in regard to adverse events as a result of not aspirating prior to injection delivery were reviewed. Curricula of selected major medical/nursing schools in India, Nigeria and Pakistan, national therapeutic formularies, product inserts of most commonly used drugs and other possible sources of information regarding aspiration and injections were consulted as well.

Keywords: Aspiration, injection

Introduction

An injection is defined by the World Health Organization [WHO] as parenteral administration of medication through a skin puncture via a syringe, while aspiration is defined as the pulling back of the plunger of a syringe [for 5–10 seconds] prior to injecting medicine 1– 4. Aspiration is most commonly performed during an intramuscular [IM] or subcutaneous [SC] injection, and is meant to ensure that the needle tip is located at the desired site, and has not accidentally punctured a blood vessel.

Despite the growing wealth of medical knowledge in recent decades, the simple procedure of aspiration is still generating much controversy concerning its perceived benefits and indications 5. Advocates of aspiration contend that it is a technically easy maneuver that is rapidly performed and well tolerated by patients with no increase in costs incurred. However, due to a paucity of available data, there is no evidence that this procedure is essential or truly beneficial. This issue has been widely debated with specific regard to vaccination; there are no studies that have assessed the need for aspiration prior to IM injection of vaccines in relation to vaccine safety. The widespread use of auto-disable [AD] syringes – most of which are not designed to aspirate 6 – has not been linked to adverse effects due to the elimination of the aspiration procedure prior to injection of vaccines 7. This finding has intensified the debate and raised doubts over the necessity of aspiration in non-vaccine medication administration as well.

Conventional syringes are also used to aspirate materials other than blood – synovial fluid, amniotic fluid, cells [via fine needle cytology], pericardial fluid, peritoneal fluid and cerebrospinal fluid [CSF] are examples 8– 19. This wide spectrum of applications for conventional syringes is all the more interesting in view of the fact that although used for both aspiration and injection, the syringe is actually designed only for injection 20. A number of studies have concluded that a conventional syringe is a poorly controlled and non-ergonomic device during aspiration 21, 22. Possible lack of precision may result in local trauma and pain, prolonged procedure time, failed or incomplete procedures, accidental puncture of blood vessels or nerve bundles, poor sample retrieval and delayed diagnosis 23– 33. The ingrained use of the conventional syringe for injection and aspiration is to a large extent attributable to its low cost, widespread availability and lack of an effective alternative 21.

The huge volume of injections being given worldwide – an estimated 16 billion injections per year are administered in the developing and transitional countries alone 34 – necessitates that this aspect of injection technique be given due attention. This review aims to collate English-language literature on aspiration from all published and non-published sources in order to provide an overview on the subject. In particular, this review aims to highlight areas of debate and draw attention to key questions that remain unanswered, thus providing a starting point for controlled studies on specific areas requiring clarification.

Methodology

A literature review was conducted using the US National Institute of Health’s PubMed service [including Medline], archives of SIGNpost, the weekly electronic newsletter of the World Health Organization’s [WHO] Safe Injection Global Network [SIGN], and International Organization of Standardization [ISO] recommendations 7886 parts 1–4 for sterile hypodermics. Clarification on points of debate was sought by direct communication with ISO. Google Scholar was also used to search for relevant information. Relevant search terms for PubMed and Google Scholar literature searches are listed below.

Guidelines from the WHO, International Council of Nursing [ICN], US Center for Disease Control [CDC], US Federal Drug Agency [FDA], UK National Health Service [NHS], British Medical Association, UK Nursing and Midwifery Council [NMC], and Australian Nursing and Midwifery Accreditation Council, Public Health Agency Canada and the Pakistan Medical Association [PMA] were extensively searched for information. Data from the WHO Program for International Drug Monitoring network in regard to adverse events as a result of not aspirating prior to injection delivery were reviewed. Curricula of selected major medical/nursing schools in India, Nigeria and Pakistan were also reviewed for relevant information to document the inclusion [or otherwise] of aspiration in teaching guidelines for injection technique.

National therapeutic manuals and formularies such as British National Formulary [BNF], European Pharmacopeia [EP], United States Pharmacopeia [USP] and Pakistan Pharma Guide [PPG] were also consulted for information regarding aspiration before injection. Product inserts for all injectable drugs on the WHO Essential Drug List [EDL] were collected to determine if the manufacturer had provided instructions on aspiration prior to injecting the drug. These product inserts were collected from local pharmacies and the international manufacturers for each drug. Drug inserts from multi-nationals were acquired either directly from their websites or from other online resources including the Drug Index [ www.Rxlist.com], Australian Prescription Products Guide [ www.appgonline.com.au/default.asp] and from [ //www.rxmed.com/].

Results

Our review was conducted between March 2008 and March 2014. Table 1 summarizes the resources searched.

Table 1.

Description of peer items reviewed with numbers reviewed.

Literature review findings

Published literature on injection technique advises aspiration before injecting a drug through different routes, i.e. IM 35, intravascular [IV] 36 or SC 37. However, it is important to note that emphasis has been placed on negative pressure being applied for 5–10 seconds for aspiration to be of benefit 1, 3, 4. During the administration of an IV injection, the presence of “flashback” [return of blood into the syringe or cannula] is a passive process and active aspiration is usually not necessitated; hence, this particular route of administration has not been emphasized in the review below.

IM injections: Aspiration prior to injection of medication through the IM route remains a part of most guidelines 4, 35, 38– 40. Nursing curricula and guidelines 4, 38, 39 clearly recommend aspiration as an essential step in IM injection technique. Guidelines originating in the UK recommend aspiration prior to IM injection of medications 35, as well as specifically as part of the Z-track technique of administering IM injections. Training curricula for community health workers in Nigeria recommend aspiration prior to IM, SC and intradermal [ID] injections 40.

SC injections: It is apparent that there are opposing schools of thought when it comes to aspiration prior to SC injections. There are those that insist that aspiration should continue to be part of SC injection techniques for medication administration, and those who are convinced that aspiration is not necessary and has no real advantage; in fact, several disadvantages may be attributed to this step.

Some nursing curricula do not include aspiration as part of the recommended technique 38 for SC injection. One nursing guideline highlights the debate existing over aspiration prior to a SC injection, concluding that while the likelihood of piercing a vessel is slim, local guidelines should be followed in determining individual practices. Others recommend routine aspiration prior to injection of medications through the SC route 42.

The WHO/ICN 43 combined guidelines do not mention aspiration. Similarly, the WHO/SIGN document 44 “A Guide For Supervising Injections” makes no recommendations related to aspiration. Both documents are primarily concerned with infection control practices in relation to injection administration, overlooking aspiration entirely.

A recent debate in relation to SC injection of immunotherapy has highlighted this controversy. Waibel recommended that aspiration before SC injection of immunotherapy be abandoned since there were no positive aspirates in 36,000 immunotherapy injections given at his practice 45. While other specialists agreed that aspiration prior to immunotherapy injection in SC tissue is very rarely positive, rare anecdotes were quoted when positive aspiration has been documented 46, 47, even in the hands of experienced specialists and nurses. Given the potentially fatal adverse reactions of immunotherapy injected into blood vessels, it is logical to recommend that aspiration be performed as part of the standard technique. However, fatal and near fatal adverse reactions have been reported following immunotherapy injection despite precautions, including aspiration, being taken 45.

Epinephrine: Epinephrine is given through the SC or IM route to treat allergic reactions. Geller 48 has reported the observation of a positive aspiration prior to epinephrine injection for asthma; if aspiration had not been performed in that instance, epinephrine would have been injected into the blood vessel with potentially hazardous consequences. On the other hand, the preloaded auto injector commonly used for administering epinephrine in emergency situations does not allow for aspiration 49. In this form, epinephrine is designed to be administered via IV injection, via intracardiac injection or via the endotracheal route into the bronchial tree where aspiration is superfluous.

Insulin: The NMC guidelines 50, 51 do not mention aspiration in relation to insulin injection. Aspiration prior to insulin injection is rarely positive 36 and hence not indicated. This recommendation is supported by drawing a parallel with heparin administration, where increased hematoma formation has been associated with aspiration 4.

Dental procedures: A study looking at dental anesthetic injections showed positive aspiration rates ranging from 3.2–8% depending on the type of syringe system used 52 and the type of nerve block. Accuracy of needle position combined with mechanical ease at the time of dental injections are important considerations when choosing an appropriate device 53. To this end, different self-aspirating devices have been tested in dental practice 54. An understanding of vascular anatomy 57 is all the more important in view of the potential toxicity of anesthetic agents and the possibility of embolization to the ophthalmic artery 58.

The US CDC screening form 55 for device specifics notes whether a dental syringe is capable of aspiration.

Immunization: Vaccinations form an important subset of all injections given worldwide. Most government programs worldwide follow UNICEF/WHO recommendation in their Expanded Program on Immunization [EPI] programs. At present, the WHO does not recommend aspiration prior to administering a vaccine 7, 56. Current guidelines published by the American Academy of Pediatrics [AAP] 57 recommend that aspiration prior to IM vaccinations may not be necessary, while similar Canadian guidelines continue to recommend aspiration 58. The US Advisory Committee on Immunization Practices [ACIP] 59 does not make any recommendations on aspiration at the time of vaccine administration. Without data indicating the need for aspiration during vaccination, ACIP is basically leaving this decision to the person giving the vaccine. A similar stance is taken by the US Immunization Action Coalition guideline 40 where aspiration is not mentioned in its recommendations for SC and IM injections in adults, and it states that there are “no data to document the necessity of aspiration” in children.

A different approach to this issue was taken by Ipp et al. 2 through a survey where the actual practice of end users was evaluated. This survey established that 74% of respondents aspirated prior to IM vaccine administration. However, of these only 3% aspirated for the recommended 5–10 seconds; the remaining applied negative pressure for 30 days old, see the
specific indications below. When intravenous use is
indicated, facilities for respiratory assistance should be
readily available.
Intramuscular: Valium Injection should be injected deeply into
the muscle.
Intravenous Use: [See warnings and precautions:
Pediatric Use.] The solution should be injected slowly,
taking at least 1 minute for each 5 mg [1 mL] given. Do
not use small veins, such as those on the dorsum of the
hand or wrist. Care should be taken to avoid intraarterial
administration or extravasation. Typhoid Vi
Polysaccharide vaccine
Typhim Vi Typhim 2 For intramuscular use only. Do NOT inject intravenously. Purified inactivated rabies
vaccine Verorab 2 Do not inject intravascularly. Lidocaine Xylocaine 1 & 3 It is essential that aspiration for blood or cerebrospinal
fluid [where applicable] be done prior to injecting any
local anesthetics, both the original and all subsequent
doses, to avoid intravascular or subarachnoid injection.
However, a negative aspiration does not ensure against an
intravascular or subarachnoid injection. Local anesthetic
solutions containing antimicrobial preservatives [e.g.
methylparaben] should not be used for epidural or spinal
anesthesia because the safety of these agents has not
been established with regards to intrathecal injection, either
intentional or accidental. Rho [D] Immunoglobin
[Human] RHO 2 Do not inject Intravenously. Do not inject neonate.

Discussion

Aspiration prior to injection is just one part of the process of performing vaccinations, therapeutic injections and diagnostic/therapeutic procedures. The debate over its inclusion as an essential part of recommended techniques has driven this review, and is likely to continue in the absence of findings from randomized controlled trials. In most instances, general clinical or vaccination experiences guide global recommendations for aspiration. In others, anecdotal reports of adverse events form the basis for inclusion or exclusion of aspiration in standard injection techniques. The sheer number of injections given globally in the preventive and therapeutic sectors makes this omission even more surprising. This appraisal of current guidelines and literature has made it clear that the need for aspiration prior to administering an injection is dependent upon multiple factors, as elaborated below.

Injections given for routine immunizations are different from injections for medications. The minimal risk of side effects combined with defined sites for immunization form one basis of the existing recommendations for eliminating aspiration during immunization. The fact that most AD devices currently in use do not allow for aspiration also appears to have been a major factor in the decision to eliminate aspiration as an essential step prior to IM or SC injection of vaccines. We argue that clinical needs should dictate the development of new devices and not the other way around. Relevant recommendations must be evidence-based and ISO guidelines must be modified to reflect evolving needs. This would drive the device industry to meet the criteria laid down based on scientific rationale.

The drug that is being injected has a direct bearing on the decision to aspirate or not to aspirate. If the drugs to be given have potentially fatal consequences in the event of systemic administration [as in the case of immunotherapy], all possible precautions must be taken. This is even more important in cases where the drug is being administered electively by specialist staff. On the other hand, if there are no serious known sequelae to a drug being injected systemically – as in the case of vaccines – an argument can be made not to aspirate, especially since a huge number of immunizations are performed globally by vaccinators and health workers. Product inserts for 104 injectables on the WHO Essential Drug List were reviewed. Of these, only 3 inserts specified that aspiration should be performed prior to injection. Two of these inserts were for local anesthetic agents and the third was for Pneumococcal 7-valent conjugate vaccine. Other product inserts mentioned the importance of injecting into the desired site, but did not specify aspiration as a way of ensuring this. Clearer instructions must be stated if indeed potentially serious complications may occur if a drug or vaccine is inadvertently administered at a site other than that recommended.

As is apparent from ISO 7886 part 4 for curative injection devices, a global shift towards the increasing the use of re-use prevention syringes in the curative sector is imminent. Devices manufactured to meet these criteria incorporate the function of aspiration. Newer devices are coming into the market in order to address the issues of control over the syringe during aspiration and to increase patient safety. One such device recently approved by the US Food and Drug Agency [FDA] is the highly controllable one handed reciprocating procedure syringe 21. Specific procedures where aspiration is performed for diagnostic or therapeutic purposes would benefit from newer devices that are custom-designed to aspirate rather than inject.

A systematic approach would be to conduct randomized controlled trials of the device to reach an unbiased conclusion on the benefits and necessity for aspiration using therapeutic re-use prevention syringes and AD syringes for vaccinations; the appropriate duration of aspiration that yields best results also needs to be determined. If such trials deem that aspiration should be part of the recommended therapeutic and vaccination technique, this would act as the driving force for the device industry to develop appropriate tools to meet these requirements.

Conclusion

There is a shortage of consistent recommendations regarding aspiration before injection in published literature, regulatory guidelines, and medical and nursing school curricula. There is also no central and easily accessible place where one can access and review information and guidelines regarding the procedure. It is therefore important to bring all the evidence, published and otherwise, to the forefront for clinicians, researchers, regulatory bodies and device manufacturers so that they can make an informed decision. Based on our findings, the need for aspiration prior to administering an injection is dependent upon multiple factors. Systemic adverse effects profile and mode of delivery [IV vs IM and SC] of drugs plays a significant role in the decision to aspirate or not to aspirate. There is ample evidence that suggests that aspiration may not be required for IM and SC injections, while for IV injections the systemic side effects of the drug should be considered when aspirating before any injection.

Literature search terms

“Aspiration”, “injection”, “technique”, “procedure”, “guidelines”, “standards”, “efficacy”, “complications”, “pain”, “trauma”, “administration”, “intramuscular”, “intravascular”, “intradermal”, “subcutaneous”, “syringe”, “auto-disable syringe”, “Z-track”, “immunotherapy”, “epinephrine”, “insulin”, “dental”, “immunization”, “vaccination”, “medication”, “rapid”, “fine-needle”, “pain”, “trauma”.

Notes

[version 3; referees: 2 approved]

Funding Statement

This literature review was funded by Star Syringe Ltd UK. All decisions regarding the content of the manuscript and final responsibility for submission of the manuscript belong to the authors.

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Referee response for version 3

1IQM Consulting for International Development of Quality Management in Transfusion Medicine, Zuidhorn, Netherlands

Competing interests: No competing interests were disclosed.

Thanks for the improved conclusion with some useful directions. That completes this interesting and disputed review on the issue of aspiration in injections. Congratulations.

I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Referee response for version 2

1IQM Consulting for International Development of Quality Management in Transfusion Medicine, Zuidhorn, Netherlands

Competing interests: No competing interests were disclosed.

The manuscript has certainly improved.

However, the added conclusion is too weak and should be enforced by including the conclusive considerations regarding the use of AD syringes, and a recommendation to the international world to synchronize guidelines and teaching materials on the practice of injection with or without aspiration.

The recommendation that 'further studies looking at the need for aspiration during injection should be conducted' is a crude generality and might follow a short listing of practical/feasible recommendations. Afterall the manuscript is written as a review, not a reporting of original research on the question 'to aspirate or not' when injecting a substance.

Minor comments:

Start the current conclusion with the word 'There' instead of 'The'.

The typo in the abstract mentioned has not yet been corrected - '... medical/-nursing ..' = '... medical/nursing ..' [delete the dash!]

I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

Referee response for version 1

1Department of Radiology, Yashoda Hospitals, Secunderabad, India

2Department of Radiology, Yashoda Hospital, Secunderabad, India

Competing interests: No competing interests were disclosed.

The manuscript is intelligently written and authors have provided a literature review of need of pre-injection aspiration and discussed its utility in clinical practice. However, we would like to make a few pertinent observations:

The authors have not concluded the review article and it would be appreciated if they could summarize their observations from the literature review and provide an appropriate conclusion giving the readers an insight into the necessity of pre-injection aspiration.

Grammatical error in abstract: medical/-nursing schools... needs to be replaced with medical/nursing.

Grammatical error in literature review [methodology] - first line - An literature review to be replaced by A literature review.

Grammatical error in Results - Immunization - Page 5: AD syringes do not permit health workers to aspirate for blood to be replaced to aspirate blood. 

Grammatical error in Findings of guidelines and recommendation [injection of medication] - Page 6 - ..Msc Nursing in India does not elaborated on injection techniques needs to be replaced with did not elaborate injection techniques.

In review of ISO guidelines, ISO section 5.3 - Page 6 - ...vaccine or medication into the syringe prior to aspiration to be replaced by ....prior to injection.  

Spelling errors in Table 2 including Diphtheria and Tetanus in second row need to be rectified.

We have read this submission. We believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

Referee response for version 1

1IQM Consulting for International Development of Quality Management in Transfusion Medicine, Zuidhorn, Netherlands

Competing interests: No competing interests were disclosed.

The authors have compiled important information based on both literature review and the analysis of guidelines and medication inserts on the issue of pre-injection aspiration once a needle is inserted in or under the skin.

However, the review might be improved by bringing in a more systematic approach in which the results follow the description in the Methodology. That would lead to a consistent and orderly review of the different aspects identified. It is also recommended to include in the introduction a definition of aspiration in the context of the review.

Table 2 shows several spelling errors that need to be corrected.

On page 6/11 [second column, last paragraph] the sentence ‘…. the drawing up of the vaccine or medication into the syringe prior to aspiration.’ erroneously uses the word aspiration where this should be injection.

A clear conclusion with feasible recommendations to come to evidence pro or con, or at least a nuancing in the pro and con of pre-injection aspiration would certainly contribute, as this is not really expressed.

I have read this submission. I believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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