Intramuscular vaccine administrations including the adoption of “Zeta-track technique” & “without aspiration slow injection technique” (ZTT & WASiT): a prospective review

Study	Participants	Injection	Intervention	Comparison	Outcomes	Bias/limitations
Yilmaz et al.³³ Semi-experimental RCT	60 patients (surgery clinic) balanced for sex/age/BMI and randomized into 2 groups.	Diclofenac sodium 3 mL; Needle: 21 G, 38 mm length; Dorsogluteal site. Positioning: face up, internal rotation of femur both in intervention and in control group.	Technique used to improve safety: ZTT performed with a displacement of 1–2 cm and combined with air-lock technique (0.3 mL of air previously drawn into the syringe). It is not specified if the injection has been associated with standard speed of 0.1 mL/s or faster (21 G needle).Technique used to reduce pain: ZTT combined with air-lock technique.	Standard technique (stretching)	Statistically significant reduction in drug leakage (P = 0.008) (measurement of drug leakage by a different researcher with a ruler in millimeters, previous use of sterile absorbent paper on the injection site immediately after injection).Non-statistically significant reduction in pain (P = 0.336) (immediate pain measured through the 100 mm VAS assessed by a nurse blinded to the intervention).	One confounding variable: It is difficult to establish the differential contribution related to air-lock technique and ZTT, but the combination of the 2 techniques is also possible, and this publication has shown the effectiveness of ZTT along air-lock (0.3 mL). The sample is not very large for obtaining results’ generalization.
Cook and Murtagh⁸ RCT	566 children aged 2–18 months in good health; infants with neurological diseases/ history of severe immediate allergic or anaphylactic reaction to any vaccine antigen were excluded.	Vaccine solution: anti haemophilus influenzae B. Needle: 25 G, 16 mm length, fully entered at 90° to the skin surface using the stretching technique in infants rather than grasping/bunching up method in infants; on the contrary CDC [45] recommend 25 G 25 mm needle in infants (1–12 months). VG site, vaccine in VG site allowing the infant to remain on the mother’s legs maintaining maternal contact (intervention) versus ALT site on the bed, observing vaccine administration in front of their eyes (control).	IMI (vaccine) in VG site (conversely CDC [6] recommend ALT site as preferred site in neonate/infants/toddlers).	Same injection and technique in ALT site	Safety improvement: Local reactions in the injection site were reduced with high statistical significance in the intervention group compared to the control one.Redness and swelling: P <0.0001; bruising: P = 0.0004. Pain reduction: vaccinee irritability and fever, persistent crying or screaming were reduced with high statistical significance in the intervention group compared to the control one, and the reflected grade of acceptability of parents in relation to their sleep deprivation, etc. (e.g., due to children care in the delta T time interval up to 24 h following vaccine’s injection) was at the same time greatly improved. Irritability: P <0.0001; fever: P = 0.0015; persistent crying or screaming: P = 0.0012; parental acceptability: P <0.0001.	No bias/limitations were detected. The outcomes demonstrate with high statistical significance the validity of the research hypothesis, despite the fact that the trial deviated from the CDC guidelines.The study by Junqueira et al.⁶⁰ confirms Cook’s⁸ outcomes with a sample of 580 newborns (0–6 months), detecting the same outcomes after the administration of hepatitis B vaccine in VG site.
Ipp et al.⁵⁸ RCT	113 infants aged 4–6 months, balanced for age and possible intake of oral analgesics before vaccination. Sample unbalanced by gender.	113 infants aged 4–6 months, balanced for age and possible intake of oral analgesics before vaccination. Sample unbalanced by gender.	113 infants aged 4–6 months, balanced for age and possible intake of oral analgesics before vaccination. Sample unbalanced by gender.	10 s aspiration performed before c + slow injection + slow withdrawal.	Safety outcome: no immediate adverse events were reported with either injection technique. Pain outcome: the immediate pain was greater in the standard versus pragmatic groups. The immunization pain score was measured within 15 s/30 s of the immunization, preceded by a baseline pain score 5 s prior to the vaccine injection. Measurements (high statistical significance): MBPS: P < 0.001; Infant crying time assessed from videotape analysis (coder blinding): P < 0.001; Percentage of crying infants P < 0.001; Pain assessment from parents based on a VAS of 0–10: P < 0.001; Pain assessment from physicians based on a VAS of 0–10: P < 0.001.	The high degree of confounding variables of the RCT is represented by having associated in a single intervention and relative observation, 3 variables in each randomized group: Experimental group: no 10 s aspiration previous IMIs + rapid injection + rapid withdrawal; Control group: 5–10 s aspiration performed + slow injection + slow withdrawal. Aspiration prior to injection has never been supported by scientific evidence in muscles suitable for immunization (deltoid, ALT, and VG sites): it was not recommended by nursing literature from 2001 [52], being independently associated with increased pain; total time’s calculation is unclear. Exclusive detection of immediate pain, without monitoring its progression (fever and irritability/ persistent infants crying or screaming in the delta T home time interval up to 24 h following injection); also the scores related to local reactogenicity in the delta T time interval up to 72 h following injection have not been measured.No pediatricians/parents blinding.It is not possible to extend the results of the study conducted on infants to all age groups.
Girish and Ravi⁶¹	200 healthy infants aged 1.5–18.0 months, with no significant differences in age, gender, and weight in the 2 randomized group of 100 infants; pre-vaccination analgesics were not used.	DTwP vaccine solution (0.5 mL) administered in ALT.Needle: 25 G, 25 mm length, inserted at 90° in in both groups. compressed muscle (grasping).	No 10 s aspiration previous IMIs + rapid needle’s advancement into the muscle + rapid injection + rapid withdrawal: entire procedure completed in 1–2 s.	Slow advancement of the needle into the muscle + 5 s/10 s aspiration performed before IMIs + slow injection + slow withdrawal; entire procedure completed in 5 s/10 s.	Safety: no immediate adverse events were reported with either injection technique.Pain: Scores relative to pain were assessed using the MBPS compiled with the 2 clinical psychologist blind versus slow/rapid technique, observing videotapes from 5 s prior to immunization (baseline) up to 15 s later. Mean duration of cry were compared using Kaplan–Meier survival analysis: it was lesser in the interventions group (32.15 s with standard error 2.020) than in the comparison group (37.37 s with standard error 1.863), and pain in the intervention group was lower than that in the comparison group (P < 0.001).	Exclusive detection of immediate pain, without monitoring its progression in the 24 h following the injection (fever and irritability/ persistent infants crying or screaming in the delta T home time interval up to 24 h following injection); also the scores related to local reactogenicity in the delta T time interval up to 72 h following injection have not been measured.The high degree of confounding variables of the RCT is represented by having associated, in a single intervention and relative observation, 4 variables in each randomized group. The first 2 variables in the comparison are independently associated with increased pain rather than reduction of it, and they are not supported by the literature: Berger and Williams⁷¹ as early as 1992 advocated introducing the needle into the site at 90° using a dart-like motion to minimize pain, and recommended inserting the needle at a 90° angle into the skin using a quick and smooth motion, to attenuate the patient’s discomfort^4,5; aspiration of 5–10 s performed before IMIs has never been supported by scientific evidence in muscles suitable for immunization⁵²; total time’s calculation is unclear.
Abdelkhalek⁴⁴ Semi-experimental RCT	30 participants in the group I (shot blocker versus standard technique for IMIs)30 participants in the group II (ZTT versus standard technique for IMIs)Adults aged 18–65 years, 60% of females in I group, 70% of females in II group, mean score of BMI was 26.33 ± 2.02 in I group, 26.63 ± 1.97 in II group. Surgical hospital.	Drug solution: neurovit 3mL, dorsogluteal muscle, 23 G (length not reported). Positioning: lateral position with knee slightly flexed.	Group I: shot blocker during IMIs.Group II: ZTT associated with WASiT (the aspiration prior to injection is not mentioned in the listed procedural algorithm, and the author states that the researcher has adopted the slow injection technique during IMIs).	Standard technique	The VDS, 6 pain descriptors) was compiled by the researcher who interviewed the patients in the immediate time after each injection: pain score was reduced both in groups I (shot blocker) and II (ZTT and WAST) compared to standard technique: P = 0.000 and P = 0.020, respectively.The level of anxiety as assessed using the “Beck Anxiety Inventory” (BAI, 21 items) was significantly reduced only in group II (ZTT and WAST) compared to standard technique (P = 0.000), but not using the shot blocker, probably seen as a new device by the patients (P = 0.330).	There is no mention of blinding with respect to the technique adopted for both the patients and the researcher administering the IMIs, as well as for the researcher administering the questionnaires.Despite proper positioning the administration of IMIs was not performed in the VG site.^72,73The total sample was not very large.
Kara and Yapucu Gunes⁵⁰ RCT (crossover design), double blinding.	86 randomized patient in postoperative care, with mean age of 46.4 ± 15.1 years;, and 38.7% of women and 46% of men; not homogeneous for BMI (mean BMI was 27.1 ± 6.08).	Diclofenac sodium (3 mL), needle: 21 G, inserted at 90°; length associated with BMI not reported.Dorsogluteal site (I injection in right side, II in left side, and III again in right site).	Technique improving safety: internal rotation of foot (B) 3 interventions in the same patient (crossover study) chosen in a random sequence with intervals of 8 h used to estimate pain: (A) Positioning: prone with toes pointing down during injection with standard technique (not declared); (B) Positioning: prone with internal rotation of 1 foot (relaxation) during injection with standard technique (not declared); (C) Same positioning in A combined with ZTT with displacement of 2.5 cm along air-lock (0.2 mL of air), and with slow technique both in injection and in needle’s withdrawal. All 3 interventions was preceded by aspiration.	(A) versus (B) versus (C)	VAS was used to assess the level of pain associated with varying BMI and with each intervention:The influence of BMI on pain was significant in A (P = 0.006) and C (P = 0.007) (the minimum common denominator was the positioning).In B (safer positioning) BMI’s influence was not significant. There was significant difference between the 3 techniques in affecting pain (P = 0.009).The patient reported less pain with (C) in comparison with (A), but less pain with B (safer positioning) in comparison with (C).The results supported the following hypothesis: “If ZTT along air-lock and slow ZTT technique is combined with the prone position with the foot internally rotated, the pain should be significantly reduced compared to the standard technique with the toes pointing down.”	In addition to injection pain, participants were already experiencing postoperative pain; moreover, both aspiration⁵² prior to injection and dorsogluteal site⁷² are independently associated with increased pain and reduction in safety. It is hypothesized that this is counterbalanced by safer positioning (internal rotation of the thigh, which is accompanied by movement of the femoral neurovascular bundle,⁷⁴ reducing but not eliminating the probability of the needle passing through it causing injury, and consequently pain). Also, relaxation from correct positioning reduces pain. Missing data: needle length not reported.The sample was not very large.
Shankar et al.⁴¹ cross sectional, analytical study	400 arms of 200 adult Indians balanced for gender, without scars and/or certain systemic diseases with varying age and BMIs (mean BMI of 24.2); radiology department.	Deltoid side, both left and right sides (in the sample all participants stated that the right arm corresponded to the dominant one).23 G, length 25 mm, inserted at 90°, leaving outside 3 mm of the needle.	Safety improvement: to make subsequent protocols for IMIs on the deltoid side safer.Thickness measurement (in cm) by ultrasound probe of: SM, MB, and SB at the deltoid IMI site on both sides of the participants’ arms; needle’s insertion (standard IMIs) to participants.	Comparison between gender and side differences in the SM and MB thickness at the deltoid site for IMIs.	Assuming a standard needle length of 25 mm, the prevalence of overpenetration in Indian adults was 50% (both male and female), while underpenetration was 1%.Correlation of SM thickness with the BMI, age, and gender: Females with the same medium BMI had a significantly higher SM thickness: P < 0.001 (subcutaneous layers thicker), and lower MB thickness: P < 0.001 (thinner muscle layer) in comparison with males.The mean thickness of the male deltoid (1.69 ± 0.4 cm) was greater than that of the female deltoid (1.48 ± 0.52 cm): P < 0.001 Right muscle thickness was significantly greater in both men (mean of measurements: 1.74 cm; side differences: P = 0.001) and women (mean of measurements: 1.52 cm; side differences: P = 0.014). When side and gender differences were considered together there was greater side differences in the SM thickness (greater subcutaneous layer) among females (P = 0.024) in comparison with males (P = 0.380).Deduction: The technique of IMIs needs to be dynamically adapted to each individual.	Missing data: It was not reported which solution was injected, but it is supposed there was performed only needle’s insertion in the deltoid site. Cook’s⁷⁵ protocol for safer landmarking was not used.

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Intramuscular vaccine administrations including the adoption of “Zeta-track technique” & “without aspiration slow injection technique” (ZTT & WASiT): a prospective review

Article Category: Review

Publicado en línea: 20 mar 2023

Páginas: 21 - 42

Recibido: 07 abr 2022

Aceptado: 14 jun 2022

DOI: https://doi.org/10.2478/fon-2023-0003

Palabras clavelocal reactogenicity, injection site reactions, injection technique safety, intramuscular injections, immunogenicity, vaccinal solution leakage, without-aspiration slow technique, Zeta-track technique

© 2023 Elena Sblendorio, published by Sciendo

This work is licensed under the Creative Commons Attribution 4.0 International License.

Study characteristics.

Palabras clave
local reactogenicity, injection site reactions, injection technique safety, intramuscular injections, immunogenicity, vaccinal solution leakage, without-aspiration slow technique, Zeta-track technique