`
`This research-based protocol might change the way you give intramuscularinjections.
`
`By Suzanne C. Beyea, MS, PhD,
`
`AJN / January 1996 / Vol. 96, No. 1
`
`AstraZeneca Exhibit 2054 p. 1
`InnoPharma Licensing LLC v. AstraZeneca AB IPR2017-00900
`
` ind Leslie H. Nicoll, MS, MBA, PhD
`
`needle. (Inserting a needle through the rubbertopof a
`vial can dull the needle or removethe needle coating
`that helpsit glide through the skin.) If you’re using a
`prefilled unit-dose syringe, check that no medication
`has dripped ontothe needle.If it has, wipe the needle
`with a dry,sterile pad before the injection.
`
`Choosing the — size syringe
`
`Whatsize syringe should you use? Try to matchit as
`closely as possible to the volume you'll be injecting.
`Less than 0.5 mL requires a low-dosesyringe that
`most closely approximates the required dose. A fine-
`ly graduated syringe (a tuberculin syringe, for exam-
`ple) will help ensure that the correct dose is adminis-
`tered.
`Research on the maximum volumeto be drawn
`up for a single injection is still inconclusive. The best
`recommendation seems to be this: For a large muscle
`such as the gluteus medius, use no more than 4 mL
`for adults and 1 to 2 mLforchildren and persons
`with less developed muscles; for the deltoid, use no
`more than 0.5 to 1 mL. Of course, you’ll want to
`minimize discomfort andtissue damage by adminis-
`tering a large dose slowly.
`Needle gauge and length depend on the consisten-
`cy ofthe solution and howfar the needle mustbe in-
`jected to reach the muscle. For most solutions, a 21-
`or 23-gauge needle is small enough to minimizetis-
`sue injury and subcutaneous leakage, yet large
`enoughto allow easy passage. Needle length de-
`pendsontheinjection site. The ventrogluteal (VG)
`area has the most consistent depth of subcutaneous
`tissue; in adults, the adipose layer is always less than
`3.75 cm. Generally, use a 1.5-inch needle for adults
`and a 1-inch needle for children.Sites with less sub-
`cutaneousfat, such as the deltoid or vastuslateralis,
`may require a 1-inch needle.
`
`o you rememberthefirst time you gave a
`patient a “shot”? Were you nervous and
`hesitant? Administering medications by
`intramuscular (IM) injectionis often the
`first invasive skill that nursing students learn.
`What manyof us don’t recall, however, is that
`even this mostbasic skill has a solid research base.
`Researchers havestudied IM sites, syringes, needles,
`and medication volumes. They’vealso studied inter-
`ventions that can reduce pain and discomfort.
`We asked over 200 nurses if they were aware of
`this research base. Mostsaid they werenot. Frankly,
`neither were we. So wedecided to explore thelitera-
`ture, going back to the 1920s. We found over 90
`studies related to IM injections. Using this literature
`and research base, we developed the following pro-
`tocol for IM injections.
`
`Preparing the medication
`Preparing an IMinjection is as importantas adminis-
`tering it. Whenever possible,use a filter needle to
`draw up medication from an ampule orvial. Hold
`the container pointed down. Don’t use the last few
`drops in the container; some have been found to
`contain foreign substances, such as glass and rubber
`particles, that you mightdraw upinto thesyringe.
`To minimize pain caused by tracking a medication
`through subcutaneoustissue, changeto a dry,sterile
`needle before giving the injection.If you’re using a
`prefilled syringe to draw up medication from a vialor
`ampule,instill the complete dose (from both the pre-
`filled syringe and thevial or ampule) into anothersy-
`ringe. This ensures that you'll be using a sharp, clean
`
`
`
`RYUJIOTANI
`
`Suzanne C. Beyea is an associate professor at Saint Anselm
`College, Manchester, NH. Leslie H. Nicollis a research associ-
`ate at the Muskie Institute, University ofSouthern Maine,
`Portland.
`
`34
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`
`
`Selecting the injection site
`We suggest the VG asthe primary site for anyone over seven
`monthsold. The underlying muscle is well developed, and the
`site is free of nerves and blood vessels. Research showsthat in-
`juries—includingfibrosis, nerve damage, abscess, tissue necro-
`sis, muscle contraction, gangrene, and pain—have beenasso-
`ciated with all the commonIM sites (dorsogluteal, deltoid, and
`vastus lateralis, for example) except the VGsite.
`There are, of course, contraindications for using the VG
`site: muscle contraction, damagein the area, and administra-
`tion of hepatitis-B vaccine. With adults, use the deltoid to ad-
`minister hepatitis-B vaccine; with infants under seven months,
`use the vastuslateralis.
`To identify the VGsite, position the palm of yourright
`handon the left greater trochanter so your index finger points
`toward the anterior superioriliac spine. (Use your left hand on
`the right greater trochanter.) Now spread your middle finger
`to form a V.Theinjectionsiteis in the middle of the V.
`
`Preparing the patient
`As with anyinjection site, carefully assess it by observation
`and palpation.If the site is indurated,inflamed, or damaged,
`choose anothersite. If all injection sites show evidence oftis-
`sue damage,consideran alternate route.
`If the VG site appears acceptable, position your patient so
`that the muscle atthesite relaxes by followingthese steps:
`-
`© For patients lying on their side, have them flex the knee,
`then pivot the leg forward from the hip approximately 20° so
`it can rest on the bed.
`* For patients in the supine position, have them flex the
`knee on the side where they’ll receive the injection (for exam-
`ple, the right knee for an injection on therightside}.
`¢ Forpatients in the prone position, have them “toe-in”to
`internally rotate the femur.
`Although it’s possible to access the VGsite while the patient
`is standing, this poses an obvioussafety risk for both the pa-
`tient and yourself.
`Prior to injection, cleanse a circular area, twoto three inches
`in diameter, with a 70% alcohol wipe. Wait at least 30 sec-
`ondsto let the alcoholdry so it won’t be introduced into sub-
`cutaneoustissue during the injection, which cancauseirrita-
`tion ofthetissue.
`
`How to administer the injection
`Donotuse an air bubble in the syringe. A holdover from the
`days of reusable syringes, this can affect the medication
`dosage by 5% to 100%. Modern disposable syringes are cali-
`brated to give the correct dose without an air bubble.
`Which injection technique should you use? Nursing text-
`books describe two methods: spreading the skin between your
`fingers, and pulling the skin down orto one side (the Z-track
`technique). Spreadingthe skin increases the risk of medication
`leaking into the needle track and the subcutaneoustissue. The
`Z-track technique virtually eliminates this risk; it also pro-
`duces fewer complications andless discomfort, makingit the
`technique of choice.
`When administering an IM injection,insert the needle quick-
`ly and smoothly, using a dartlike motion andsteady pressure,
`at a 90° angle to theiliac crest, in the middle of the V you
`
`AJN / January 1996 / Vol. 96, No. 1
`
`formed with your fingers. After insertion, aspirate for five to
`10 seconds. That may seem like a long time, but when the
`needle is in a small, low-flow bloodvessel, it takes a while for
`the blood to appear. If no blood appears, inject the medica-
`tion slowly—approximately 10 seconds per mL. This slow,
`steady rate promotes comfort and allowstimeforthetissues
`to expand and begin absorbingthe solution.
`After you’ve injected the solution, wait 10 seconds so that
`the medication can diffuse through the muscle. Then smooth-
`ly withdraw the needle at the same angle of insertion. Once
`the needleis out, use a dry, sterile sponge to apply gentle pres-
`sure at the site. Don’t massagethesite; this could cause tissue
`irritation.
`Encourage the patient to perform leg exercises, such asflex-
`ion and extension, to help the muscle absorb the medication.
`Inspect the injection site within two to four hours. When you
`administer the next injection, check the formersite for red-
`ness, swelling, pain, or other evidence oftissue damage. These
`findings are not normalor to be expected. They should be
`documented according to your agency’s policy and communi-
`cated in a timely mannerto the primary physician for further
`evaluation and treatment measures.
`
`More research is needed
`The research on IM injections isstill continuing. An important
`area for study is the volume that various musclescansafely
`and comfortably absorb. For example, researchers have
`found various absorption rates for different muscles, but no
`one has documented the rate of absorptionin the gluteal
`medius(target muscle of the VG site) or comparedit with oth-
`er muscles. More research also needs to be done on interven-
`tions for complications from IM injections. Although more
`than 200 adverse effects have been documented in thelitera-
`ture, no onehas explored theefficacy of various interventions
`in minimizing these complicationsafter they occur and in pro-
`moting healing.
`Nurses have always wanted to provide a level of care that
`ensures the fewest possible negative outcomes. Today, this
`means studying the research that hasa direct influence onclin-
`ical practice. Next time you give an IM injection, follow the
`protocoloutlined here. Your techniquewill be solidly ground-
`ed in research,
`
`SELECTED REFERENCES
`
`Beecroft, P. C., and Redick, S. A. Possible complications ofintramuscularinjections
`onthe pediatric unit. Pediatr.Nurs. 15(4):333-336, 376, July-Aug. 1989.
`Beyea, S. C., and Nicoll, L. H. Administration of medications via the intramuscular
`route: An integrative review oftheliterature and research-based protocolfor the
`procedure. Appl.Nurs.Res. 8(1):23-33, Feb. 1995.
`Cockshott, W.P., et al. Intramuscular orintralipomatousinjections? N.Engl.J.Med.
`307(6):356-358, Aug, 1982.
`Farley, H.F., et al. Will that im needle reach the muscle? Am].Nurs. 86(12):1327—
`1328, Dec. 1986.
`Keen, M. F. Comparisonofintramuscular injection techniquesto reducesite
`discomfort andlesions. Nurs.Res. 35(4):207-210, July-Aug. 1986.
`Keen, M.F. Get on the right track with Z-track injections. Nursing 20(8):59, Aug.
`1990.
`
`Newton, M.,et al. Reviewing the “big three”injection techniques. Nursing 72(2):
`34-41, Feb. 1992.
`Rettig, F. M., and Southby, J. R. Using different body positions to reduce discomfort
`from dorsoglutealinjection. Nurs.Res. 31(4):219-221, July—Aug. 1982.
`Zenk, K. E. Beware of overdose. Nursing 3:28-29, Mar. 1993.
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`AstraZeneca Exhibit 2054 p. 2
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