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`MYLAN PHARMS. INC. EXHIBIT 1038 PAGE 1
`
`MYLAN PHARMS. INC. EXHIBIT 1038 PAGE 1
`
`

`
`Journal of Advanced Nursing, 2000, 31(3), 574±582
`
`Integrative literature reviews and meta-analyses
`
`Drawing up and administering
`intramuscular injections: a review
`of the literature
`
`Michael A. Rodger BSc(Ed) PGDAd MSc RN
`Staff Nurse, Renal Unit, King's College Hospital, London
`
`and Lindy King PhD BN(Ed) RN
`Lecturer in Nursing Studies, King's College London, London, England
`
`Accepted for publication 14 July 1999
`
`Journal of Advanced Nursing 31(3), 574±582
`RODGERRODGER MM.AA. && KINGKING L. (2000)L. (2000)
`
`
`Drawing up and administering intramuscular injections: a review of the
`literature
`Intramuscular (IM) injections have been an integral part of drug administration
`in nursing practice for almost half a century. However, there are some
`con¯icting practices which warrant investigation to determine their effective-
`ness in this aspect of patient care. To this end, this paper presents the results of
`a literature review which was carried out in order to establish current
`understanding of present day knowledge, procedures and guidelines for the
`administration of IM injections. Areas addressed within this review include
`injection sites used, injuries associated with IM injections, issues surrounding
`needle selection and volume administered through IM injections, injection
`techniques and nursing skills associated with IM injections. Synthesis of the
`research reviewed allows the development of research-based guidelines for this
`skill. These guidelines offer a framework for nurses who wish to provide
`practice in line with current research into the process of drawing up and
`administration of intramuscular injections.
`
`Keywords: intramuscular injections, evidence-based nursing practice
`
`INTRODUCTION
`
`Smith & Duell (1988) and Winslow (1996), suggest that the
`teaching of IM injections has become an integral part of
`nursing syllabi. The literature review reported here was
`therefore undertaken in order to develop an under-
`standing of present day knowledge, procedures and
`guidelines in the drawing up and administration of
`intramuscular injections to inform both practice and nurse
`education. Several databases were employed (CINAHL
`
`Correspondence: Dr Lindy King, Research in Nursing Studies,
`Florence Nightingale Division of Nursing and Midwifery,
`King's College London, James Clerk Maxwell Building, Waterloo Road,
`London SE1 8WA, England.
`
`and MEDLINE) to develop an initial reference list. This
`was followed by a study of clinical nursing texts and
`cross-referencing of the articles to identify any gaps in the
`literature.
`themes such as drug
`Within this paper, central
`administration, injection sites used, issues surrounding
`technique, nursing skills and problems associated with
`IM injections are reviewed. Despite a number of
`discrepancies between authors,
`the review provides
`suf®cient consensual evidence for the establishment of
`clinical
`guidelines
`for
`the
`drawing
`up
`and
`administration of
`IM injections.
`It
`is suggested that
`further studies will be required to determine the extent
`to which nurses adhere to research-based guidelines in
`this ®eld.
`
`574
`
`Ó 2000 Blackwell Science Ltd
`
`MYLAN PHARMS. INC. EXHIBIT 1038 PAGE 2
`
`

`
`Integrative literature reviews and meta-analyses
`
`Administering intramuscular injections
`
`ROUTES OF DRUG ADMINISTRATION
`
`Parenteral medication refers to medication given by
`routes other than oral, topical or inhalation and thus
`encompasses drugs given intradermally, subcutaneously,
`intramuscularly or by intravenous (IV) infusion (Berger &
`Williams 1992). John & Stevenson (1995 p. 1194) state
`that `by choosing the most appropriate route for drug
`administration it
`is possible to optimize therapy'.
`Intramuscular injections tend to be utilized to admin-
`ister medication requiring a relatively quick uptake by
`the body but with reasonably prolonged action. As with
`all drug prescriptions, medication dosage,
`time and
`method of administration should be checked with
`another nurse.
`
`INTRAMUSCULAR INJECTION SITES
`
`Newton et al. (1992 p. 36) claim that `properly adminis-
`tered, an IM injection deposits medication under the
`muscle fascia below the fatty subcutaneous layer'. These
`authors suggest that this skeletal muscle has fewer pain-
`sensing nerves than subcutaneous tissue, thus decreasing
`discomfort, and that larger volumes of drug can be injected
`due to the rapid uptake into the bloodstream through
`muscle ®bres. Further, Craven & Hirnle (1996 p. 622)
`contend that `site choices are in¯uenced by the age of the
`client,
`the medication to be injected,
`the amount of
`medication to be injected and the general condition of
`the client'. Damaged or scarred tissue, poor muscle mass
`or tone and accessibility or mobility factors may also
`contra-indicate a particular site (Hahn 1990, Newton et al.
`1992, Covington & Trattler 1997).
`Numerous authors including Mallet & Bailey (1996),
`Kozier et al. (1993) and Craven & Hirnle (1996) suggest
`that
`there are ®ve sites that can be utilized for the
`administration of IM injections. Nurse educators would
`appear to teach from one to all of these sites. We contend
`that it is incumbent on educationalists to present current
`research evidence on the use of all ®ve sites for IM
`injections. An understanding of each of the ®ve sites is
`essential if nurses are to make informed decisions with
`regard to administration of IM injections. These sites (the
`deltoid, dorsogluteal, rectus femoris, vastus lateralis and
`ventrogluteal Ð see Figure 1 for diagrammatic display of
`sites) are described below.
`
`The deltoid site
`Intramuscular injections into the mid-deltoid muscle, like
`other IM injections, should be given into the densest part
`of the muscle. This is located `by drawing an imaginary
`horizontal line two to three ®nger breadths 2á5±5 cm
`below the lower edge of the acromion process' (Craven &
`Hirnle 1996 p. 622). The injection should be given into an
`imaginary triangle whose base is the central half of this
`
`horizontal line and whose apex is formed inverted on the
`midpoint of `the lateral aspect of the arm in line with the
`axilla' (Kozier et al. 1993 p. 871).
`Mallet & Bailey (1996) state that due to the small area of
`this site, the number and volume of injections which can
`be given into it are limited. For example, vaccines which
`are usually small in volume tend to be administered into
`the deltoid site (Mallet & Bailey 1996).
`
`The dorsogluteal site
`Often referred to as the upper outer quadrant, the method
`of dividing the buttock into four equal areas by drawing
`imaginary lines to bisect it vertically and horizontally has
`been utilized by many nurses over the years to locate this
`injection site. Craven & Hirnle (1996) suggest that the site
`is better located by palpating to ®nd the greater trochanter
`and the posterior iliac spine, then injecting laterally and
`superior to the midpoint of an imaginary line joining these
`points.
`The presence of major nerves and blood vessels, the
`relatively slow uptake of medication from this site
`compared with others and the thick layer of adipose
`tissue commonly associated with it, make this site prob-
`lematic (Bolander 1994, Rosdahl 1995).
`Injury constitutes a major threat with the use of this area
`for IM injections. The sciatic nerve and superior gluteal
`artery lie only a few centimetres distal to the injection site,
`thus great care needs to be taken to identify landmarks
`accurately.
``Palpating the ileum and the trochanter is
`important; visual calculations alone can result
`in an
`injection that is placed too low and injures other struc-
`tures' (Kozier et al. 1993 p. 870).
`Injections should not be given into this area whilst the
`patient is standing (Bolander 1994). Similarly, Rettig &
`Southby (1982) conclude that patients should assume a
`prone or side lying position with the femur internally
`rotated to minimize pain at the injection site by relaxing
`the muscle group.
`
`The rectus femoris site
`Located midway between the patella and superior iliac
`crest on the mid-anterior aspect of the thigh (Bolander
`1994), this site incorporates a large and well-developed
`muscle. The uptake of drugs from this region is slower
`than from the arm but faster than from the buttock, thus
`facilitating better drug
`serum concentrations
`than
`is possible with the gluteal muscles (Newton et al.
`1992).
`The site may be utilized when other sites are contra-
`indicated or by clients who administer their own medi-
`cation according to Kozier et al. (1993) as it is readily
`available in the sitting or lying back position. These
`authors and colleagues
`(Berger & Williams 1992),
`however, note that its main disadvantage is that injections
`into this area may cause considerable discomfort.
`
`Ó 2000 Blackwell Science Ltd, Journal of Advanced Nursing, 31(3), 574±582
`
`575
`
`MYLAN PHARMS. INC. EXHIBIT 1038 PAGE 3
`
`

`
`M.A. Rodger and L. King
`
`The deltoid site
`
`The dorsogluteal site
`
`Injection site
`
`Injection site
`
`Humerus
`
`Brachial artery
`
`Radial nerve
`
`Sciatic nerve
`
`Greater trochanter
`of femur
`
`Posterior superior iliac spine
`
`The rectus femoris and
`vastus lateralis sites
`
`Femur
`
`Vastus lateralis
`(injection site)
`
`The ventrogluteal site
`
`Greater trochanter of femur
`
`Anterior superior iliac spine
`
`Injection site
`
`Iliac crest
`
`Rectus femoris
`(injection site)
`
`Patella
`
`4
`
`Figure 1 Intramuscular injection sites (illustration by Alison Tingle).
`
`The vastus lateralis site
`
`This muscle, like the rectus femoris, is associated with
`the quadriceps femoris group of muscles (Bolander
`1994) and has similar absorptive properties (Craven &
`Hirnle 1996). For IM injection purposes,
`the lateral
`aspect of the thigh between the greater trochanter of the
`femur and the lateral femoral condyle of the knee, is
`divided into thirds with the middle third being used as
`the injection site.
`One of the advantages of the vastus lateralis site, is its ease
`of access but more importantly there are no major blood
`
`vessels or signi®cant nerve structures associated with this
`site. The bulk of muscle tissue of non-atrophied patients in
`this region further reduces the likelihood of injury.
`
`The ventrogluteal site
`The ventrogluteal site was originally proposed as an
`appropriate IM injection site by Hochstetter (1954). This
`site is easily accessible for most patients and located as
`Kozier et al. (1993) suggest, by the nurse placing the heel
`of his/her opposing hand (i.e. right hand for left hip) on
`the client's greater trochanter. The index (second) ®nger of
`the hand is placed on the client's anterior superior iliac
`
`576
`
`Ó 2000 Blackwell Science Ltd, Journal of Advanced Nursing, 31(3), 574±582
`
`MYLAN PHARMS. INC. EXHIBIT 1038 PAGE 4
`
`

`
`Integrative literature reviews and meta-analyses
`
`Administering intramuscular injections
`
`1
`
`spine and the middle ®nger stretched dorsally towards but
`below the iliac crest. The triangle formed by the index
`®nger, the third ®nger and the crest of the ilium is the
`injection site.
`thickness of gluteal
`The site provides the greatest
`muscle (consisting of both the gluteus medius and gluteus
`minimus), is free of penetrating nerves and blood vessels
`and has a narrower layer of fat of consistent thinness than
`is present in the dorsogluteal (Zelman 1961
`).
`The ventrogluteal site has come to attract signi®cant
`attention in the nursing literature and is seen by many as
`being the site of choice for IM injections (Beecroft & Redick
`1990, Hahn 1990, Covington & Trattler 1997). However,
`Farley et al. (1986), in a study at a large midwestern (USA)
`teaching hospital involving the entire nursing population
`(nˆ 875), found that only 12% of nurses utilized this
`location. Furthermore, Cockshott et al. (1982) noted that
`nurses in their study only used the dorsogluteal site for IM
`injections. The extent to which the ventrogluteal site is
`used in the United Kingdom (UK) is unknown.
`Craven & Hirnle (1996 p. 62) state that the site is not
`appropriate until around the age of 3 years and claim that
`for this age group, the rectus femoris should be `the site of
`choice'. However, Kozier et al. (1993 p. 869) assert that the
`site is suitable for all patients, regardless of age and
``particularly suitable for
`immobilized clients whose
`dorsogluteal muscles may be atrophying'.
`Research suggests that knowledge and use of appro-
`priate sites reduces the likelihood of injuries identi®ed
`with the giving of IM injections. Injuries associated with
`IM injections are numerous and it is incumbent on nurses
`to minimize this risk by making sound choices in practice.
`
`INJURIES ASSOCIATED WITH
`INTRAMUSCULAR INJECTIONS
`
`2
`
`Winslow (1996) claims that the ventrogluteal site is the
`only area for IM injections that does not appear to have
`any reported associated injuries. It could be argued that its
`relatively infrequent use by nurses (Farley et al. 1986) may
`have contributed to this ®nding. However,
`the site's
`uniform and minimal
`layering of
`adipose
`tissue
`(Michaels & Poole 1970), overlapping muscle structure
`providing depth of tissue for injection (Zelman 1961
`), and
`absence of major blood vessels or nerves (Craven & Hirnle
`1996), may be more likely factors.
`Reported injuries associated with sites other than the
`ventrogluteal
`for
`IM injections include contractures,
`palsy, peripheral nerve injury,
`local
`irritation, pain,
`infection, neuropathy, haematomas, bleeding, persistent
`nodules, arterial punctures, permanent damage to sciatic
`nerve resulting in paralysis, ®brosis, abscess,
`tissue
`necrosis, gangrene, and muscle contraction (Farley et al.
`1986, Feldman 1987, Hahn 1990, Beyea & Nicoll 1995,
`Winslow 1996).
`
`The ease of access, especially in out-patient settings for
`IM injections such as tetanus toxoid boosters (Newton
`et al. 1992), possibly adds to the frequency with which the
`deltoid site is used. Pain appears to be one of the most
`frequently reported complications associated with this
`site (Greenblatt & Allen 1978). However, its relatively
`small area and muscle mass, especially in atrophied
`patients, compounded by the close proximity of the radial
`nerve, brachial artery and bony processes to this site
`means that more substantial injuries may occur (Berger &
`Williams 1992, Rosdahl 1995).
`In light of the literature, Beyea & Nicoll (1995, 1996)
`conclude that more research exploring nurses' interven-
`tions which reduce the likelihood of complications from
`IM injections is warranted. This research needs to focus
`not only on the prevention of complications but also on
`what is done to minimize these effects after they occur and
`promote healing. Important to effective administration are
`the choices made in relation to needle selection and
`determination of
`the volume that can be given into
`particular sites during IM injection. Similarly, monitoring
`of the site post-injection for early detection of trauma is
`important. Mallet & Bailey (1996) recommend observation
`of the injection site 2- to 4-hourly post-injection.
`
`ISSUES SURROUNDING NEEDLE SELECTION
`AND VOLUME ADMINISTERED FOR
`INTRAMUSCULAR INJECTIONS
`
`For IM injections, Lenz (1983) advocates a technique
`known as the pinch test in order to determine the length of
`needle required to penetrate subcutaneous layers and
`deposit medication into the muscle group elected. For the
`deltoid and quadriceps group of muscles the arm or leg is
``pinched' between thumb and fore®nger in a manner that
`allows the muscle to be palpated between thumb and
`®nger. Lenz (1983) states that half the distance between
`thumb and fore®nger plus (0á6±1á3 cm) to allow for the
`exposed hub of the needle on insertion, represents the
`length of the needle required.
`The gluteus muscle groups are not easily `grasped',
`therefore a slightly different
`technique needs to be
`employed. The thumb and fore®nger are used to `pinch'
`the skin and subcutaneous tissue. This time half the
`distance between thumb and fore®nger should represent
`the depth of tissue to reach the muscle. The nurse then
`determines the extra length to penetrate well into the
`muscle mass and allow for the exposed hub. For frail
`patients this may only require a 1-inch needle but for very
`obese patients, Lenz (1983) argues, 4±6 inches or longer
`will be required.
`Cockshott et al. (1982 p. 357), in analysing over 200
`simulated injections to the dorsogluteal region by nurses,
`found through computerized axial
`tomography (CAT)
`scans of the sites that `under 5% of the women and under
`
`Ó 2000 Blackwell Science Ltd, Journal of Advanced Nursing, 31(3), 574±582
`
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`

`
`M.A. Rodger and L. King
`
`15% of the men would have actually received an intra-
`muscular
`injection into the glutei'. This
`study is
`supported by Newton et al. (1992) who assert that for
`the humanitarian reason of trying to save their patients
`pain, nurses underestimate the length of needle required
`to deposit medication into the intended muscle.
`Pertinent to this issue, Lenz (1983) notes that pain
`receptors are concentrated in the skin and hence the
`length of needle, once the point of
`the needle has
`penetrated should not substantially affect the pain level
`detected by the patient. However, Lenz argues, depositing
`medication into subcutaneous tissue can signi®cantly
`raise the pain the patient experiences. Further, posi-
`tioning the patient to relax muscles (Kruszewski et al.
`1979) and pressing on the site for 10 seconds pre-injecting
`(Barnhill et al. 1996) has been demonstrated to decrease
`signi®cantly the pain levels experienced.
`John & Stevenson (1995) declare that only small
`volumes can be given intramuscularly and warn that it
`may be necessary to split the dose to avoid painful
`injections and allow appropriate absorption. Beyea &
`Nicoll (1996) observe that there is a lack of clarity in
`relation to a precise optimum volume; there appears to be
`some consensus about the maximum volume. Injection
`into a large muscle group should not exceed 5 ml in adults
`(Berger & Williams 1992, Newton et al. 1992, Rosdahl
`1995).
`The deltoid site would appear to be the most conten-
`tious with regard to the volume that it can accommodate.
`Some authors (Rosdahl 1995, Craven & Hirnle 1996)
`contend that it should not be used in infants under
`18 months and then progress via an age-related scale to
`2 ml at adulthood. Covington & Trattler (1997) state that
`the maximum volume that should be administered at this
`site is only 1 ml.
`At the other IM sites, Craven & Hirnle (1996) argue,
`larger volumes can be accommodated. These authors state
`that in adults, up to 2á5 ml can be safely injected into the
`ventrogluteal, 4 ml into the dorsogluteal and 5 ml into the
`vastus lateralis, with lesser amounts being stipulated in
`younger patients or with people with less developed or
`atrophied muscle beds.
`The literature also gives guidance as to the size of the
`syringe and the rate of administration of medication via
`the intramuscular route. The size of the syringe used
`should be determined by selecting the smallest possible
`to accommodate the given volume. Volumes of less than
`0á5 ml should be given with low dose syringes to ensure
`accuracy (Zenk 1993). Further, throughout their study,
`Rettig & Southby (1982) maintain a minimum adminis-
`tration time of 5 seconds to reduce the pain of each IM
`injection. More recently, Farley et al. (1986) and Keen
`(1990) espouse an administration rate of no faster than
`1 ml per 10 seconds to facilitate absorption and mini-
`mize pain. No research has been found to indicate the
`
`extent to which nurses comply with this administration
`rate.
`
`INTRAMUSCULAR INJECTION TECHNIQUES
`
`With the increased use of patient-controlled analgesia
`(PCA) pumps in hospitals, the number of IM injections
`given for pain control is declining (Mackintosh & Bowles
`1997). Despite evidence (Egbert et al. 1990, Gould et al.
`1992) that PCAs are more effective at controlling postop-
`erative pain, Alexander et al. (1994) argue that the intra-
`muscular
`route
`of
`analgesic
`administration
`still
`constitutes a means of attaining pain control for signi®cant
`numbers of patients in hospital. Given their use with other
`medications as well, it is incumbent on nurses to employ
`techniques of IM injection-giving, which maximize the
`patient's safety and minimize the discomfort in¯icted. The
`following section outlines those techniques that nurses
`need to consider.
`
`Use of the `air bubble technique'
`
`The use of what is commonly referred to as the `air bubble
`technique' in the giving of an IM injections is contentious.
`Authors such as Bolander (1994), Rosdahl (1995) and
`Hahn (1991) state that by drawing up 0á1±0á3 ml of air into
`the syringe, the air bubble so formed can be used to expel
`all of the medication thus preventing it from seeping into
`surrounding tissue causing irritation and tissue damage.
`Berger & Williams (1992) warn, however, that the practice
`can be dangerous and potentially lead to an overdose
`being administered. Modern syringes are calibrated so as
`not to incorporate the use of an air bubble (as was the case
`in older glass syringes), but to deliver accurately the dose
`drawn up in the syringe, allowing for residual medication
`to remain in the hub of the syringe and needle. Zenk
`(1993) argues vehemently that the practice of using an air
`bubble is dangerous, in particular with small doses, as it
`can result in more than double the prescribed dose being
`delivered.
`
`Cleaning of the injection site
`
`The cleaning of injection sites with alcohol swabs and
`other means has been debated for a number of years. Many
`authors (Smith & Duell 1988, McConnell 1993, Bolander
`1994) recommend the practice for injection in order to
`minimize the risk of
`infection. Argument
`is levelled
`against the use of iodophers such as poridone-iodine
`(Mallet & Bailey 1996) in that they discolour the skin and
`can make it dif®cult to note adverse reactions. Other
`research studies question the value of the practice alto-
`gether. In a classic study conducted over 6 years and
`involving more than 5000 injections, Dann (1969) found
`no single case of local and/or systemic injury reported.
`
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`
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`

`
`Integrative literature reviews and meta-analyses
`
`Administering intramuscular injections
`
`Similarly Koivistov & Felig (1978) conclude that whilst
`skin preparations did reduce skin bacterial count, they are
`not necessary to prevent infections at the injection site.
`Berger & Williams (1992) argue that the cleaning mater-
`ial can be tracked along the needle path to cause irritation
`but no substantial evidence of this has been reported.
`However, Mallet & Bailey (1996 p. 232) advise nurses to
`clean the skin prior to injection `because patients are
`immuno-compromised and the risk of contamination from
`the patient's skin ¯ora is increased'. As the procedural
`guidelines recommended by Mallet & Bailey (1996) are
`adopted by many hospitals in Britain and the practice is
`advocated by a large number of nursing authors, the
`cleansing of the injection site may be more common than
`not. Given the lack of recent research in this area, the
`authors conclude that the site should be cleaned in line
`with Mallet and Bailey's recommendations.
`
`Use of ®ltration needles
`
`Hahn (1990) and McConnell (1993) recommend the use of
`®lter needles when drawing medication from a vial or
`ampoule in order to prevent shards of glass or rubber
`particles being injected into the patient. If such needles
`are not available Mallet & Bailey (1996) advise that
`medication should be drawn up through narrow bore
`needles (21 gauge or smaller). It could be argued that to
`approximate more closely the bore of ®ltration, needles 23
`gauge or smaller are required to minimize the likelihood of
`foreign particles being drawn into the syringe. The needle
`should then be changed to prevent foreign objects trapped
`in the needle being transferred to the patient and to
`decrease irritation due to tissue damage from medication
`clinging to the outside of the shaft.
`
`Methods of intramuscular injection
`
`The nursing literature suggests that there are two methods
`for administering IM injections. The standard method
`involves spreading the skin above the injection site
`between the ®ngers of the practitioners' non-dominant
`hand. Alternately, the Z-track technique uses the non-
`dominant hand to pull the skin and subcutaneous tissue
`1±1á5 inches to one side of the injection site (Hahn 1990).
`Authors such as Craven & Hirnle (1996), Berger &
`Williams (1992) and others advocate introducing the
`needle into the site at 90° using a quick dart-like motion
`to minimize pain. Bolander (1994) encourages the use of
`distraction techniques such as engaging the patient in
`conversation prior to the thrust of the needle whereas
`others (Hahn 1990 p. 57) advocate that a warning such as
``take a deep breath' should be given.
`Beyea & Nicoll (1996) argue that the standard technique
`of spreading the skin increases the risk of medication
`leaking into the needle track and subcutaneous tissue
`whereas the Z-track technique creates a disjoint perfor-
`ation or broken injection pathway that locks medication
`into the target muscle (see Figure 2 for details). This
`method of preventing ¯ow-back was ®rst demonstrated by
`Shaffer (1929) yet many nurses are unaware of its advant-
`ages. Shepherd & Swearington (1984) note that the Z-track
`technique can be used in any appropriate muscle group
`provided that the overlying tissue can be displaced by at
`least 1 inch.
`Keen's (1986) study of 50 subjects requiring regular
`analgesia for pain related to sickle cell anaemia or pan-
`creatitis offers pertinent ®ndings to this issue. The
`patients were randomly assigned to receive Z-track and
`standard injections to opposite ventrogluteal muscles and
`
`a)
`
`05
`
`b)
`
`05
`
`c)
`
`05
`
`Figure 2 The z-track technique a) using your non-dominant hand, pull the skin and subcutaneous tissue 2±3 cm sideways; b) pierce
`the skin with a quick dart-like motion at 90°. Aspirate for blood, if none, slowly inject the medication; c) withdraw the needle and
`release the skin to create a disjointed pathway which locks in the medication. Note: remember to use a long enough needle to reach the
`target muscle so that medication is not deposited in subcutaneous tissue. (Illustration by Alison Tingle.)
`
`Ó 2000 Blackwell Science Ltd, Journal of Advanced Nursing, 31(3), 574±582
`
`579
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`MYLAN PHARMS. INC. EXHIBIT 1038 PAGE 7
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`

`
`M.A. Rodger and L. King
`
`these were administered by one person in the research
`team. Thus as half the group had the Z-track into the left
`ventrogluteal and half into the right, each group served as
`its own control having excluded any patients from the
`study who had notable differences in muscle group from
`one side of their body to the other. These patients reported
`varying discomfort levels at the sites through the use of a
`Likert scale. Keen (1986) found a signi®cant decrease in
`both pain and injection site lesions associated with the
`Z-track sites. Although the study is marred by its use of an
`air bubble technique, the ®ndings are pertinent as one
`considers the advantage of increasing serum concentration
`levels by containing medication to the target muscle.
`Indeed these results show why Keen (1986, 1990) has been
`joined by Newton et al. (1992) and Beyea & Nicoll (1995,
`1996) in stating that the Z-track should be the technique of
`choice for all IM injections.
`A number of authors (Smith & Duell 1988, Kozier et al.
`1993, Beyea & Nicoll 1995) argue that the practitioner
`should leave the needle inserted for 5±10 seconds
`following the completion of drug administration. Others
`(Keen 1990, Hahn 1990) claim this is onl