Comparison of efficacy of needle-free injection versus injection by needle for iron supplementation of piglets: a double blind randomized controlled trial.

BACKGROUND: In pig husbandry, most piglets receive an intramuscular injection with iron around three days of age for the prevention of hypochromic, microcytic anaemia. In recent years an increased interest is noted for needle-free injections, because of efficiency and safety for man and animal. This study aims to support the evidence on efficacy to extent the registration of a commercial iron supplement with a needle-free administration application. To this aim the study has two objectives: 1) to determine the effect of needle-free injection of the iron supplement on the mean blood Haemoglobin level at weaning, as primary outcome, and mean Haematocrit and mean Body weight of pigs at weaning as secondary outcome compared to no treatment, as main determinant of iron deficiency anaemia in piglets at time of weaning; 2) to compare the effects of needle-free administration of the iron supplement with regular injection by needle, with regard to the course over time of Haemoglobin, Haematocrit, piglet growth and the differentiated haematological and serum iron parameters. METHODS: A double blind randomized controlled trial was conducted with 72 piglets, 8 piglets per litter from 9 litters. At three days of age pigs were selected, based on body weight, and random allocated to three study groups: a) control non-treated group (2 pigs per litter, 18 in total), b) a group with regular iron injection by needle injection (3 pigs per litter, 27 in total), c) a group that received iron by needle-free injection (3 pigs per litter, 27 in total). At four points in time (day 3, 14, 26 and 40) piglets were weighed and bled to analyse the dynamics of red blood counts and haematological parameters as well as serum iron parameters. The primary outcome parameter was the Haemoglobin (Hb) level on day 26. Of secondary importance were Haematocrit (Ht) and body weight (BW) at weaning and parameters with tertiary importance were the course of Hb, Ht and differentiated red blood cell parameters, serum iron, iron binding capacity and iron saturation. In the statistical analyses, linear mixed effect regression modelling was used to account for repeated measures within litters and pigs. RESULTS: The analyses showed that needle-free administration was as efficacious to prevent iron deficiency anaemia at day 26 as administration using regular needle injection, compared to the control group. The mean level of Hb and Ht of pigs in the needle and needle-free group did not differ significantly. No side effects were observed. CONCLUSION: It is concluded that needle-free iron administration of the tested product is as efficacious as regular administration by needle injection.

Effect of a needle-free system versus traditional anesthesia on pain perception during palatal injections in children.

BACKGROUND: Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research on this topic in children is required. AIM: The purpose of this clinical study was to evaluate the effectiveness and patient preference of a needle-free system versus traditional anesthesia (TA) on pain perception during PIA in children. DESIGN: The study was designed as a randomized, controlled crossover clinical study with 48 children aged 6-12 years requiring dental treatment with PIA in bilateral maxillary primary molars. TA was applied on one side and the Comfort-in™ injection system (CIS) on the other side in two separate sessions. Then, patient preference was recorded. The pain perception during PIA was evaluated using the Wong-Baker FACES Pain Rating Scale (PRS) and the Face, Legs, Activity, Cry, Consolability (FLACC) Scale. The data were analyzed for statistical significance (p < .05). RESULTS: There were statistically significant differences between the TA and the CIS according to the PRS and FLACC Scale scores. On both scales, significantly higher pain ratings were observed in the TA group during PIA (p < .001). There was a statistically significant difference in terms of patient preference (p < .001). Although 77.1% (n = 37) of the children preferred the CIS, 22.9% (n = 11) preferred the TA. Moreover, patient preference for the CIS was significantly higher in older children (p < .01). CONCLUSIONS: The application of a needle-free system during PIA ensured a decrease in pain perception in children.

Modelling uptake and transport of therapeutic agents through the lymphatic system.

The ability of the lymphatic network to absorb large molecules and bypass the first-pass liver metabolism makes it appealing as a delivery system for therapeutic substances. In most cases, the drug is injected into the subcutaneous tissue and must negotiate the tissue space, before being drained via the lymphatics. Tracking the transport of drug molecules through this route is challenging, and computational models of lymphatic drainage can play an important role in assessing the efficacy of a proposed delivery strategy. The three-dimensional computational model we present here of the peripheral lymphatic network and surrounding interstitium is informed by anatomical data, and quantifies the degree to which uptake and transit times are affected by drug particle size, physiological flow rates, and specifics of drug injection.

A retrospective study comparing different injection approaches of 5-aminolevulinic acid in patients with non-melanoma skin cancer.

BACKGROUND: 5-aminolevulinic acid through a needle-free, plum-blossom needle or conventional needle followed by photodynamic therapy are available options for non-melanoma skin cancer treatment. AIM: To compare these three techniques of injection of 5-aminolevulinic, regarding treatment response and adverse effects in patients with non-melanoma skin cancer. PATIENTS AND METHODS: Non-melanoma skin cancer patients have received six cycles of 0.5 mL intralesional 20% w/v 5-aminolevulinic acid through a conventional needle (CPT cohort, n = 158), or plum-blossom needle (BPT cohort, n = 118), or needle-free injection (NPT cohort, n = 105) followed by irradiation with a red light. Data regarding treatment response and adverse effects were collected and analyzed. RESULTS: The treatment response was higher among patients of NPT cohort than those of CPT (p = .012, q = 3.981) and BPT (p = .012, q = 3.472) cohorts. Conventional and plum-blossom needle injections therapies were reported scar, local redness, and worse cosmetic appearance in the follow-up period. CONCLUSIONS: Needle-free injection of intralesional 5-aminolevulinic acid followed by irradiation with red light therapy were reported high treatment response with manageable adverse effects for non-melanoma skin cancer patients than that of conventional and plum-blossom needle injections. LEVEL OF EVIDENCE: III.

Does the use of Dermojet affect the concentration of platelet-rich plasma? An in vitro experimental investigation.

Needle-free injection systems with high jet pressure have been used for seven decades for drug or vaccine administration via intradermal, subcutaneous, and intramuscular routes. These systems are used for the application of mesotherapy drugs in plastic surgery and dermatology. Platelet-rich plasma (PRP) tissue regeneration is applied intradermally by a needle for different indications, such as wound healing and scar revision. To prevent complaints such as pain, erythema, and ecchymosis by patients during this application, PRP was applied using Dermojet, a jet injector system with a spring-loaded system. In this study, after measuring the average platelet count in PRP preparations obtained from 18 volunteers, a 2.5 cc PRP shot into an empty tube was performed with Dermojet. The mean platelet count was measured in a homogenized tube. The same procedures were performed for platelet-poor plasma (PPP). The platelet loss rates for PRP and PPP were compared. In addition, the amount of PRP in each shot of the Dermojet was calculated. When PRP and PPP were applied using the Dermojet, platelet loss was 8.41% and 8.33%, respectively. The difference in the number of platelets formed in PRP and PPP when applied with Dermojet was not statistically significant. PRP application with needle-free injection systems, such as Dermojet, may be an alternative because of patient comfort and the negligible platelet loss compared with the PRP application with the standard needle injection.

Needle-Free Injection of Vesicular Phospholipid Gels-A Novel Approach to Overcome an Administration Hurdle for Semisolid Depot Systems.

Vesicular phospholipid gels (VPGs) are depot formulations for the sustained release of drugs which are characterized by a high amount of phospholipids in the formulation. They consist of physiological excipients only and therefore display high biocompatibility. Their manufacture is simple, cheap, solvent free, and ideal for the processing of proteins and peptides because of the low stress on the molecule, for example, by elevated temperatures. One major hurdle of VPGs is their high viscosity which makes them hard to almost impossible to inject with conventional, thin needles used for subcutaneous administration. However, so far no data are published to overcome this administration challenge. In the present study, needle-free injection was investigated and successfully applied as a technology for the easy and elegant administration of VPGs. VPGs with different phospholipid content were injected with a Biojector 2000 into gelatin blocks and full thickness pig skin postmortem as in vitro models and the injection depth was determined after injection. The release behavior was tested after shearing the VPG with the device to evaluate the effect of shearing on the drug release from the formulation. No differences were observed when compared to an ejection with needle and syringe.