Microneedles: A minimally invasive delivery system for ocular treatment.

This review article delves into the extensive use of microneedles in ocular therapy, emphasizing their efficacy in delivering drug substances to the posterior region of the eye. The conventional methods of drug delivery, while widely employed, are marred by inherent drawbacks such as neovascularization, abrasion, and infiltration. To address these limitations, the review explores various approaches to microneedle fabrication, shedding light on the diverse materials employed in the process. Furthermore, the article meticulously examines the delivered drug substances using distinct microneedle approaches and their applications in ocular therapy. By critically evaluating the drawbacks associated with conventional ophthalmic drug delivery, the review seeks to pave the way for a paradigm shift. It advocates for a novel approach centered around minimally invasive microneedles, presenting them as a promising solution to overcome the limitations of current drug delivery methods. The comprehensive discussion within this article not only offers insights into the fabrication techniques and materials used for microneedles but also provides a nuanced understanding of the applications and advantages associated with this innovative approach. As the exploration of microneedle technology continues to evolve, this review serves as a valuable resource for researchers, clinicians, and pharmaceutical professionals seeking to enhance ocular therapy by embracing the potential of minimally invasive microneedles.

Considering skin-to-muscle depth for successful intramuscular injections in an increasingly obese population.

BACKGROUND: Intramuscular (IM) injection practice is an essential nursing skill. Current practice relies on clinical judgement to determine needle length (unless specified in the medicine's product licence). Obesity is increasing in the global population, but guidelines have largely ignored how to select needle length to meet individual patient need. AIM: The aim of this review was to systematically review the skin-to-muscle depth required to achieve injection into muscle in adults. The objectives were to identify any implications of obesity status when selecting an appropriate needle length and site in clinical practice. Search and review methodology: Studies of subjects above the age of 18 years using observational or experimental designs where the distance from the skin to muscle had been measured at any IM injection site, and obesity status was reported, were included in the search strategy. The primary outcome of interest was the distance from skin surface to muscle penetration. FINDINGS: 14 studies were identified that investigated the dorsogluteal, ventrogluteal, deltoid and vastus lateralis sites, all used cross-sectional observational designs. Ten used ultrasound, three used computed tomography (CT) and one used magnetic resonance imaging. Obesity status was reported as BMI or hip-to-waist ratio. In all studies there was a correlation between obesity status and the distance from skin surface to muscle. In females this exceeded 37 mm at both gluteal sites, independent of obesity status. CONCLUSIONS: There should be an assessment of obesity status before selecting needle length for IM injections in both genders. Needles longer than the standard 37 mm are recommended for all females, whatever their obesity status, for any gluteal site. Injections into gluteal sites should be avoided in females who are obese. Deltoid injections are more likely to achieve muscle penetration in both genders, and in patients who are overweight or obese. Further research is required.

Dorsogluteal intramuscular injection depth needed to reach muscle tissue according to body mass index and gender: A systematic review.

AIMS AND OBJECTIVE(S): The objective of this systematic review was to determine the needle length required to reach the dorsogluteal muscle based on body mass index and sex. Our aim was to provide evidence-based recommendations to current intramuscular injection guidelines from the result(s) of this review. BACKGROUND: Studies worldwide are documenting reduced medication effectiveness due to improperly placed dorsogluteal intramuscular injections because of incorrect needle length, wrong site selection and/or obesity. Current intramuscular injection guidelines lack specific instructions according to weight or sex. While there are similar concerns with other injectable sites, this review focuses solely on adult dorsogluteal intramuscular injections. DESIGN: A systematic review of relevant literature of dorsogluteal intramuscular injections based on body mass index and sex. METHODS: This systematic review was reported using the PRISMA checklist 2020. The review protocol was registered with Center for Open Science (OSF). We analysed 1,412 articles from nine databases. We compared twelve studies that utilised computerised tomography or ultrasonography using The Johns Hopkins Evidence-Based Practice Model and Guidelines. RESULTS: A significant number of dorsogluteal intramuscular injections are administered into subcutaneous tissue rather than muscle because needles are too short for populations with body mass indexes over 25, especially women. Poor landmarking often results in improperly placed injections. CONCLUSIONS: To prevent administering a dorsogluteal intramuscular injection into subcutaneous tissue, women with a BMI of 25 and over require needles longer than 38 mm (1.5 inches). Men have less subcutaneous tissue in the dorsogluteal area and only require longer needles if BMI is 35 and over. If skin-to-muscle depth is questionable in either sex, an ultrasound-guided intramuscular injection is warranted for accurate dorsogluteal placement. Landmarking and needle length are key to appropriately placed IM injections. RELEVANCE TO CLINICAL PRACTICE: Dorsogluteal injections are often injected into subcutaneous tissue rather than muscle because needles are not long enough to reach muscle, especially in women. Critical elements that determine placement of intramuscular injections into muscle versus subcutaneous tissue are sex, BMI, needle length and landmarking. Medications delivered into subcutaneous tissue may have reduced bioavailability.

Anterolateral thigh measurements by ultrasound in neonates and young infants to ensure safe intramuscular injections during vaccination in low- and middle-income countries.

BACKGROUND: Use of same length needle for intramuscularly administered vaccines had been reported to cause under-and over-penetration among infants due to their different body weights and underlying variations in the fat and muscle thickness. Normative data regarding thigh compartment thickness are, however, lacking among neonates and infants aged ≤12 weeks particularly in low- and middle-incoming countries with high burden of low birth weight/growth restricted infants. METHODS: Present study investigated skin to muscle and skin to bone (STBD) distances of anterolateral thigh of babies (n = 300) aged ≤12 weeks (1-80 days) with different weight groups (<3 kg, 3-4 kg and >4 kg) by ultrasonography during their intramuscular vaccinations. RESULTS: Overall, mean [standard deviation (SD)] STBD was 17.04 (2.66) mm with range of 10.60-23.30 mm. Stratifying by current body weight, mean (SD) STBD in infants weighing less than 3 kg was 14.39 (1.23) mm. For infants weighing between 3-4 kg and >4 kg, the mean (SD) STBD were 16.69 (1.43) mm and 17.04 (2.66) mm, respectively. Estimated safety (no risk of over-penetration) of 16 mm was observed in 57.33% (172) infants whereas 25 mm needle had 100% over-penetration risk in the study cohort. Current body weight of infants was a significant predictor of safe injection [area under the receiver operating characteristic (ROC) curve 0.95; 95% CI 0.92-0.97]. CONCLUSIONS: Our study offers objective normative measurements of anterolateral thigh for safe intramuscular vaccination in young infants especially for low birth weight and growth restricted infants in low- and middle-income countries.

Optimizing insulin delivery for patients with diabetes.

Management of diabetes for residents in long-term care settings is particularly challenging, due to the wide range of physical and mental limitations that bear on efficacy of their medications, as well as practical issues associated with the optimal administration of these medications. Foremost among the practical issues for residents requiring insulin injections, is the need to ensure that it is consistently delivered to the circulation at the target rate and dosage, thereby avoiding life-threatening episodes of hypoglycemia. Recent evidence from a multinational survey has elucidated principles of insulin injection technique, including optimal needle length and site rotation that can greatly improve consistency in delivering insulin to the subcutaneous compartment, while reducing pain, improving patient compliance, and limiting the total daily dosage. The present review consolidates these findings and highlights the most critical take-home messages for healthcare professionals working in this area.

Examination of Subcutaneous Tissue Thickness in the Thigh Site for Intramuscular Injection in Obese Individuals.

OBJECTIVES: The aim of the study was to investigate the thickness of subcutaneous (SC) tissue in the dorsogluteal and thigh sites in obese adults and its suitability for intramuscular injection using a standard-length needle. METHODS: The sample for this prospective study consisted of 54 obese adults who presented to the ultrasound unit of the radiology clinic of a university hospital in the province of Izmir, Turkey, between June 2012 and August 2013. The study received Institutional Review Board approval, and informed written consent was obtained from all participants. The thickness of the SC tissue in the dorsogluteal and thigh sites was measured by sonography. The sonographic measurements were performed by a radiology specialist. RESULTS: The mean thicknesses of the SC tissue were 61.70 ± 15.73 mm in the dorsogluteal site, 27.05 ± 8.52 mm in the rectus femoris site, and 23.23 ± 8.44 mm in vastus lateralis site. The SC tissue was thicker in the dorsogluteal than the thigh site (P < .001). CONCLUSIONS: A standard needle used in intramuscular injections to the thigh site would be effective in reaching the muscle in the rectus femoris and vastus lateralis sites in all men and in 77.8% of women, although it is not usually adequate for gluteal injection.

COVID-19 vaccination and the skin to deltoid MUSCLE distance in adults with diabetes.

Objectives: To estimate the proportion of adult diabetics with a skin to deltoid muscle distance (SDMD) of > 25 mm, representing a distance greater than the standard needle length used for intramuscular COVID-19 vaccination, and to assess whether anthropometric measurements predict ultrasound SDMD measurements. Design: Non-interventional cross-sectional study. Setting: Single site, non-clinical setting, Wellington, New Zealand. Participants: One hundred participants (50 females) aged at least 18 years diagnosis with diabetes. All participants completed the study. Main outcome measures: The proportions of participants with a SDMD > 25 mm and a SDMD > 20 mm (indicating that the needle would not have penetrated at least 5 mm into the deltoid, which is considered necessary to ensure deposition of vaccine into muscle); the relationship between anthropometric measurements (body weight, body height, body mass index (BMI), skinfold thickness, arm circumference) and SDMD measured by ultrasound. Results: The proportion (95 %CI) of participants with a SDMD > 25 mm was 6/100; 6 % (2.2 to 12.6), and the proportion with a SDMD > 20 mm was 11 % (5.6 to 18.8), of which 9/11 had a BMI ≥ 30 kg/m2 and 9/11 were female. The strongest relationships between anthropometric measurements and SDMD were with arm circumference (r = 0.76, P < 0.001) and BMI (r = 0.73, P < 0.001). Arm circumference and BMI were the best predictors of SDMD measurements with AUC for ROC curves of 0.99 and 0.94 above the 25 mm cut point, 0.97 and 0.89 above the 20 mm cut point respectively. Conclusions: The standard needle length of 25 mm is likely to be insufficient to ensure deposition of COVID-19 vaccine within the deltoid muscle in a small but important proportion of obese adults with diabetes. Arm circumference and BMI are simple measurements that could identify those that need a long needle to ensure successful intramuscular vaccine administration. Funding: Ruth Maud Ring Spencer Estate; Health Research Council of New Zealand (Independent Research Organisation).

When should a longer needle be used for intramuscular injection in obese patients? A combined analysis of New Zealand data.

AIM: To estimate thresholds for Body Mass Index (BMI) and arm circumference above which a longer needle is needed to ensure intramuscular (IM) delivery of a vaccine in the deltoid muscle at the site recommended by New Zealand (NZ) immunization guidelines. METHODS: A combined analysis of two studies, including 442 adults, with measurements of arm circumference, BMI and skin to deltoid muscle distance (SDMD) at the NZ immunization guideline-recommended IM injection site. Receiver Operator Characteristic curves identified arm circumference and BMI cut-points that gave 100% sensitivity for SDMD thresholds. These thresholds were: SDMD of 20 mm, accounting for a minimal penetration of 5 mm into muscle with the standard needle; and 25 mm, which is the length of a standard needle for IM injection, representing the depth this can reach. RESULTS: Cut-point values for arm circumference, at which a longer needle would be required, were higher for males than females: 35 cm versus 30 cm for the 20 mm cut-point, and 40 cm versus 36.7 cm for the 25 mm cut-point respectively. The BMI cut-points were also higher for male than females: 24.6 kg/m2 versus 23.7 kg/m2 for the 20 mm cut-point, and 38.2 kg/m2 vs 31.6 kg/m2 for the 25 mm cut-point respectively. CONCLUSION: Arm circumference and BMI cut-points provide practical measures from which to choose a needle length that increases the chance of successful IM vaccination. Based on our data, an arm circumference of 35 cm for men and 30 cm for women should prompt selection of a longer needle to ensure intramuscular injection at the deltoid site. Thresholds for the different skin to deltoid sites proposed internationally should be determined to enable successful IM vaccination in clinical practice beyond NZ.

Evaluation the injectability of injectable microparticle delivery systems on the basis of injection force and discharged rate.

BACKGROUND: Subcutaneous injection of biopharmaceutical agents or microparticles is challenging due to issues with low injection efficiency and high residual amounts. OBJECTIVE: This study aimed to determine the important factors affecting the injectability of microparticle delivery systems, establish a suitable injection system with lower injection force and higher discharge rate, and eventually develop a reliable injectability evaluation system for injectable microparticle delivery systems in vitro and in vivo. METHODS: The effects of various parameters, including particle size, injection speed, concentration of microspheres suspension, vehicle viscosity, needle length and gauge were evaluated by measuring the injection force and discharge rate. The characteristics of microparticles and rheological measurement of the suspension systems were studied. A design of experiment approach was utilized to evaluate the interaction between the microsphere suspension, vehicle viscosity and needle gauges. Both in vitro sieve tests and in vivo tests in rats were conducted to evaluate injectability. RESULTS: The in vitro test results showed that the vehicle viscosity and injection speed have varying effects on discharge rate and injection force, respectively. Particle size and needle gauge have substantial influence on injectability, larger particle size and smaller needle gauges resulting in poor injectability, while the needle gauge was found to have the greatest influence on injectability. Levonorgestrel (LNG) microsphere and glass bead were relatively uniform spherical, the glass bead had extremely smooth surface; while mesoporous silica had irregular shape. The settling rate of glass bead was the fastest, which was about 18 times faster than the LNG microsphere. The CMC-Na had a poor interaction with the LNG microspheres, glass bead and mesoporous silica and showed basically Newtonian behavior in the shear rate range of 0.1 s-1-100 s-1. When shear rate increased to more than 100 s-1, no obvious shear thinning behavior was observed. CMC-Na formed a nodule structure with whether LNG microspheres or the glass beads, which were much lower than that with the mesoporous silica in static state, among which the glass beads were the weakest. The viscosity of the suspension increased with the rising of the volume fraction of particles. Fundamentals of hydrodynamics in capillaries were referenced, such as Navier-Stokes Law equation, Krieger-Dougherty (K-D) equation, Hagen-Poiseuille equation. The best results achieved was using a suspension concentration of 120-240 mg /mL and a viscosity of 60 cP at 20 °C with 23-gauge needles. The optimized conditions were verified in vivo tests. It was proven that the LNG microsphere suspension had a good injectability when injected into subcutaneous tissue of rats. CONCLUSION: The injection system of injectable microparticle delivery system with lower injection force and higher discharge rate was established and the evaluation method was suitable for the injectability evaluation both in vivo and in vitro. Improved injectability would promote the clinical translation of microparticle delivery systems.

Needle Technology for Insulin Administration: A Century of Innovation.

Innovations in syringe and pen needle (PN) technology over the last 100 years have led to important advances in insulin delivery for people with diabetes, paralleling the strides made in developing recombinant DNA human insulin and insulin analogs with varying onset and duration of action. In this review, the history of advances in insulin delivery is described, focusing on progress in syringe, needle, and PN technologies. The early glass and metal syringes that required sterilization by boiling have been replaced by disposable, single-use syringes or pens with clear labeling for precise insulin dosing. The early needles ranging in length from 19 to 26 mm that required manual sharpening against a whetstone have been replaced by syringe needles of 6 mm and PNs of 4 mm in length as slender as 34 gauge. Imaging studies using ultrasound and computed tomography measured the thickness of skin and subcutaneous tissue layers to show feasibility of targeted insulin administration with shorter needles. These developments, coupled with innovations in needle/PN wall and tip structure, have led to improved injection experience for people with diabetes. It is also important to acknowledge the role of injection technique education, together with these advances in injection technology, for improving clinical outcomes and patient satisfaction. With continued projected growth of diabetes prevalence, particularly in developing countries where expensive and complex insulin delivery systems may not be practical, insulin syringes and pens will continue to serve as reliable and cost-effective means of insulin delivery for people with diabetes.

Appropriate Needle Length Determined by Ultrasonic Echography for Intramuscular Injection in Japanese Elderly over 50 Years.

Adjuvanted vaccines are administered through intramuscular injection. To perform appropriate injection using an appropriate needle in different age groups or different daily living activities, we investigated the depth from the skin surface to muscle fascia and bone in the deltoid muscle area in 156 elderly aged ≥ 50 years by ultrasonic echography. Subjects consisted of 50 healthy elderly aged 50−64 years, 50 subjects aged 65−74 years, and 56 subjects aged ≥ 75 years (20 outpatients, 18 who needed nursing care, and 18 bedridden in a nursing home). The mean depth ± 1.0 SD from the skin surface to muscle fascia was 7.52 ± 2.13 mm for subjects aged ≥ 75 years, being shorter than 9.16 ± 3.02 mm in those aged 50−64years (p < 0.01). The depth from the skin surface to bone was 22.54 ± 3.85 mm for subjects aged ≥ 75 years and 25.41 ± 4.24 mm for those aged 65−74 years, significantly shorter than those aged 50−64 years (p < 0.01), depending on the reduced muscle volume. The subcutaneous volume length was greater in females (8.29 ± 2.63 mm) than in males (5.62 ± 2.80 mm) aged 50−64 years (p < 0.01). A similar result was obtained in those aged 65−74 years, but there was no difference in the muscle volume length. Our study found that a five-eighths of an inch (16 mm) needle was an appropriate length for average-sized elderly aged ≥ 50 years, but it should be longer for those with large body sizes.

The effect of needle length and skin to deltoid muscle distance in adults receiving an mRNA COVID-19 vaccine.

BACKGROUND: The mRNA COVID vaccines are only licensed for intramuscular injection but it is unclear whether successful intramuscular administration is required for immunogenicity. METHODS: In this observational study, eligible adults receiving their first ComirnatyTM/BNT162b2 dose had their skin to deltoid muscle distance (SDMD) measured by ultrasound. The relationship between SDMD and height, weight, body mass index, and arm circumference was assessed. Three needle length groups were identified: 'clearly sufficient' (needle exceeding SDMD by >5 mm), 'probably sufficient' (needle exceeding SDMD by ≤ 5 mm), and 'insufficient' (needle length ≤ SDMD). Baseline and follow-up finger prick blood samples were collected and the primary outcome variable was mean spike antibody levels in the three needle length groups. RESULTS: Participants (n = 402) had a mean age of 34.7 years, BMI 29.1 kg/m2, arm circumference 37.5 cm, and SDMD 13.3 mm. The SDMD was >25 mm in 23/402 (5.7%) and >20 mm in 61/402 (15.2%) participants. Both arm circumference (≥40 cm) and BMI (≥33 kg/m2) were able to identify those with a SDMD of >25 mm, the length of a standard injection needle, with a sensitivity of 100% and specificities of 71.2 and 79.9%, respectively. Of 249/402 (62%) participants with paired blood samples, there was no significant difference in spike antibody titres between needle length groups. The mean (SD) spike BAU/mL was 464.5 (677.1) in 'clearly sufficient needle length' (n = 217) compared with 506.4 (265.1) in 'probably sufficient' (n = 21, p = 0.09), and 489.4 (452.3) in 'insufficient needle length' (n = 11, p = 0.65). CONCLUSIONS: A 25 mm needle length is likely to be inadequate to ensure vaccine deposition within the deltoid muscle in a small proportion of adults. Vaccine-induced spike antibody titres were comparable in those vaccinated with a needle of sufficient versus insufficient length suggesting deltoid muscle deposition may not be required for an adequate antibody response to mRNA vaccines.

Prospective Comparison of Longer Needle Lengths to Assess the Risk of OnabotulinumtoxinA-Associated Neck Pain in Patients with Chronic Migraine.

BACKGROUND: We aimed to prospectively assess the role of needle length in improving the tolerability/safety profile of OnabotulinumtoxinA (BoNTA) for chronic migraine (CM) prophylaxis, with a specific focus on neck pain, based on patients' body habitus and other variables. METHODS: BoNTA was administered quarterly for two consecutive cycles, using the standard 0.5-inch 27 G needle at all pre-defined PREEMPT injection sites, except the left-hand side trapezius and paraspinal muscles, which were injected using longer needles of 1-inch 23 G at first and 1-inch 27 G at second infusion. Participants were interviewed at day 14 following each session for evidence of neck pain. The predictive significance of Body Mass Index (BMI) and other variables with neck pain was also examined. RESULTS: A total of 100 consecutive CM patients were evaluated, and each patient served as her/his self-control. The incidence, duration and intensity of neck pain did not significantly differ using either 1-inch needle compared with standard 0.5-inch 27 G needle, although the incidence and characteristics of neck pain with the use of longer needles appeared slightly higher and more intense. The BMI index and other tested variables remained unrelated to neck pain. CONCLUSIONS: We were not able to identify significant differences or correlations in the incidence, characteristics and location of neck pain with the use of different needle length to inject BoNTA, although the use of the longer 1-inch needles likely increased the risk of this adverse event.

A CFD-based approach to optimize operating parameters of a flow-through scintillation cell for measurement of 220Rn in indoor environments.

The measurements and monitoring of 222Rn/220Rn have been of emerging interest in occupational environments particularly in radium/thorium handling facilities and environments with monazite deposits for the inhalation dosimetry. The performance of a flow-through Lucas scintillation cell (LSC) for long run 220Rn measurements, depends upon the exact distribution pattern of 220Rn and its decay products in the LSC which can vary with the design of inlet path and flow rates. In this work, the CFD technique has been used to study the concentration profiles of 220Rn and its decay products in LSC for varying flow rates and inlet needle lengths. The variation of alpha production efficiency (ηα) is computed and analyzed for each case; aiming to select the best operating range of parameters for the optimum performance of LSC for 220Rn measurements. It is seen that LSC can be operated in the flow rate ranging from 0.6 to 1 lpm with inlet needle length varying from 22.5 to 45 mm for improved sensitivity.

Evaluating the User Preference and Level of Insulin Self-Administration Adherence in Young Patients With Type 1 Diabetes: Experience With Two Insulin Pen Needle Lengths.

Background Selecting the appropriate insulin pen needle is important to reduce pain and injection-related adverse events like insulin leakage. It also helps to improve medication adherence and glycemic control in patients with type 1 diabetes mellitus (T1DM). Objective This study aimed to compare the 6-mm and 8-mm 32.5-gauge insulin pen needles in terms of glycemic control, pain score, user preference, medication adherence, and injection adverse events in patients with T1DM. Methods We conducted a prospective cohort study of 62 patients with T1DM. All patients constituted an experimental group initially and then changed the length of the needle to be part of a self-control group. The glycemic control, visual analog scale (VAS) pain score, Morisky Medication Adherence Scale (MMAS) score, needle attribute score, and injection-related adverse events were measured for all patients with both lengths of needles. Patients were assessed at the baseline visit and followed up for three months. Statistical comparisons were done by the chi-squared test, paired t-test, and paired Wilcoxon test when appropriate with a two-tailed alpha level below 0.05 indicating statistical significance. Results With the NanoPass® 32.5-gauge, 6-mm needle (Terumo Corp., Tokyo, Japan), patients had significantly lower glycated hemoglobin (HbA1c) compared to 8-mm needles (7.9% vs. 8.3%; p<0.001). The proportions of patients who reported no hypoglycemic episodes were 22/62 and 9/62, with the 6-mm and 8-mm needles, respectively. The 6-mm needles were better in terms of the following parameters compared to 8-mm needles: mean needle attribute scores (36.7 vs. 24.2; p<0.001), median VAS pain scores (20 vs. 55; p<0.001), insulin leakage (6/62 vs. 20/62; p=0.002), and the MMAS score (4.9 vs. 3.4; p<0.001). Conclusion This study provided an overview of the safety, adherence, pain score, and glycemic control relating to the 6-mm and 8-mm insulin needle lengths. Insulin injections using the NanoPass 32.5-gauge, 6-mm needle were associated with lower pain score, higher patient adherence, fewer adverse events, and better glycemic control compared to the 8-mm needle. Therefore, we recommend the use of the NanoPass 6-mm needle for patients with T1DM. Further studies are needed to confirm these findings in patients with type 2 diabetes mellitus (T2DM).

Insulin injection technique in the western region of Algeria, Tlemcen.

INTRODUCTION: Algeria has more than 1.7 million diabetic patients on to whom a descriptive assessment particularly on the insulin usage behaviors has not yet been initiated, although is needed. This study aims to provide a descriptive analysis of how Algerian diabetic patients perceive and apply insulin injection techniques. METHODS: using the "patient" questionnaire within the Injection Technique Questionnaire (ITQ) 2016 survey, this study assessed the insulin injection practices of 100 patients recruited over a seven-month period in western Algeria at the Tlemcen University Hospital Center. The results of this study are compared to those of the ITQ 2016 survey. RESULTS: pens are the instruments of injection for 98% of Algerians who continue to use mostly long needles of 6- and 8-mm, although 4mm needles are the recommended safer option. Insulin analogues (fast and basal) are plebiscite. Arms and thighs are the preferred injection sites; the abdomen (the preferred site elsewhere) is neglected for reasons to be investigated. The correct re-suspension technique for cloudy insulin is unknown. Extensive pen needle re-use (10+ times) for over half of the patients exposes them to both higher intramuscular (IM) injection risk and lipohypertrophy (LH). Injection training is performed in Algeria by the diabetologist. CONCLUSION: this study describes for the first time Algerian patients´ insulin injection technique. It highlights their skills and identifies many deficiencies which patients and professionals must correct given the issues in this area.

Assessment of distance from skin surface to muscle for evaluation of the risk of inadvertent intramuscular insulin injection at potential injection sites among patients attending a tertiary care children's hospital in Sri Lanka-an observational study.

BACKGROUND: Insulin therapy is essential for type 1 diabetes. While a reasonable glycemic control prevents complications, inadvertent intramuscular (IM) insulin injection results in hypoglycemia and fluctuations of blood glucose levels. OBJECTIVE: To assess the subcutaneous thickness (SCt) at the potential insulin injection sites, in order to determine the suitable needle length. METHODS: Diabetic and non-diabetic children (n=125; aged 2-14 years) attending a tertiary care hospital were examined, after excluding those who had skin abnormality at the injection site, were hospitalized for>3 days, or had any other chronic illnesses. Dermal thickness (Dt) and SCt at the potential insulin injection sites were measured with ultrasonography. RESULTS: The mean age of the patients was 8 years and 57% were boys; mean Dt was 2.1±0.4 mm, SCt was 7.45.6±3.7 mm, and maximum SCt was 29.8 mm in the anterior abdominal wall. SCt increased with age and by raising a skin fold (sf). There was no difference (P>0.05) in Dt between genders, and limbs showed thinner Dt values than the abdomen. SCt changed with the injection site: it was the lowest in the thigh and the highest in the abdomen. SCt was thicker in females, with or without sf (P<0.001). For all sites, IM risk was high for 15-mm needles: it was highest in the thighs (98%) and reduced to 86% with sf. IM risk was low for 5-mm needles: it was highest in the thigh (38%), and reduced to 12% with sf. Compared with girls (up to 42%), IM risk was higher for boys (up to 54%), even for 5-mm needles with a sf. CONCLUSION: Using a short needle is recommended for children, particularly for boys. Regardless of the needle length, the raised sf technique is associated with reduced IM risk.

Epinephrine delivery via EpiPen® Auto-Injector or manual syringe across participants with a wide range of skin-to-muscle distances.

BACKGROUND: Intramuscular (IM) injection of epinephrine (adrenaline) at the mid-anterolateral (AL) thigh is the international standard therapy for acute anaphylaxis. Concerns exist regarding implications of epinephrine auto-injector needles not penetrating the muscle in patients with greater skin-to-muscle-distances (STMD). METHODS: This open-label, randomized, crossover study investigated pharmacokinetics and pharmacodynamics following injection of epinephrine in healthy volunteers. Individuals were stratified by maximally compressed STMD (low, < 15 mm; moderate, 15-20 mm; high, > 20 mm). Participants received epinephrine injections via EpiPen® Auto-Injector (EpiPen; 0.3 mg/0.3 mL) or IM syringe (0.3 mg/0.3 mL) at mid-AL thigh or received saline by IM syringe in a randomized order. Eligible participants received a fourth treatment (EpiPen [0.3 mg/0.3 mL] at distal-AL thigh). Model-independent pharmacokinetic parameters and pharmacodynamics were assessed. RESULTS: There were numerical trends toward higher peak epinephrine concentrations (0.52 vs 0.35 ng/mL; geometric mean ratio, 1.40; 90% CI 117.6-164.6%) and more rapid exposure (time to peak concentration, 20 vs 50 min) for EpiPen vs IM syringe at mid-AL thigh across STMD groups. Absorption was faster over the first 30 min for EpiPen vs IM syringe (partial area under curve [AUC] over first 30 min: geometric mean ratio, 2.13; 90% CI 159.0-285.0%). Overall exposure based on AUC to the last measurable concentration was similar for EpiPen vs IM syringe (geometric mean ratio, 1.13; 90% CI 98.8-129.8%). Epinephrine pharmacokinetics after EpiPen injection were similar across STMD groups. Treatments were well tolerated. CONCLUSIONS: Epinephrine delivery via EpiPen resulted in greater early systemic exposure to epinephrine vs IM syringe as assessed by epinephrine plasma levels. Delivery via EpiPen was consistent across participants with a wide range of STMD, even when the needle may not have penetrated the muscle.Trial registrationsThis trial was registered with the German Clinical Trials Register (DRKS-ID: DRKS00011263; secondary ID, EudraCT 2016-000104-29) on 23 March 2017.

Guiding Principles for the Recognition, Diagnosis, and Management of Infants with Anaphylaxis: An Expert Panel Consensus.

Infant anaphylaxis is an emerging risk, with food allergy the most common cause. Although the presentation of anaphylaxis involves the same systems as in older children and adults, there are real-world challenges to identifying symptoms of an allergic emergency in nonverbal children, as well as implementing optimal treatment. Recognition of anaphylaxis in infants can be challenging because allergic symptoms and certain normal infant behaviors may overlap. Intramuscular epinephrine is the treatment of choice for infants, as it is for older children and adults, and an epinephrine autoinjector approved by the Food and Drug Administration is now available for infants weighing between 7.5 and 15 kg. A panel of experts sought to develop guiding principles for the recognition, diagnosis, and management of anaphylaxis in infants, and provide a framework for the development of new guidelines and future research. Accordingly, anaphylaxis emergency action planning for infants was addressed by the panel. In considering formation of future infant anaphylaxis guidelines, health care providers should be aware of the needs to improve the recognition, diagnosis, and management of infants with anaphylaxis. Future research should identify and validate clinical criteria for the diagnosis of anaphylaxis in infants, as well as risk factors for the most severe reactions.

Unintentional injection to the bone with a pediatric epinephrine auto-injector.

BACKGROUND: Skin-to-bone distance (STBD) in children prescribed a pediatric epinephrine auto-injector (EAI) for anaphylaxis is not commonly measured in practice. Recent evidence suggests that children with STBD less than the exposed needle length of available pediatric EAIs (dose: 0.15 mg, needle length: 12.7 mm) are at risk for unintentional injections to the bone during their use for an allergic emergency. CASE PRESENTATION: Described here is a case of a female child with multiple food allergies prescribed a pediatric EAI (0.15 mg EpiPen Jr®) who experienced an unintentional injection to her femur. The patient's STBD at the recommended injection site (vastus lateralis) was shorter than the needle length of her prescribed EAI (12.7 mm) at the time of the injury (age: 7, height: 122 cm; weight: 25 kg), even though her weight was within the indication for this EAI (15-30 kg). The patient and her family were made aware of the risk of unintentional bone injection at the time the EAI was prescribed. CONCLUSIONS: Some children, even those at an appropriate weight per the indication of available pediatric EAIs (0.15 mg), may be at risk for unintentional injections to the bone. The effects of an unintentional bone injection with an EAI can have lasting effects on a child, including pain. Healthcare providers who prescribe pediatric EAIs for any child should consider evaluating this risk, inform patients and parents of the risk, and take measures to potentially mitigate unintentional bone injections. For some children, an EAI with a shorter needle length may be a more appropriate choice of treatment for anaphylaxis.