Objective:A disposable autoinjector was developed for subcutaneous (SC) self-injection by patients with chronic diseases. To verify its performance and evaluate its acceptance, a clinical study was conducted in healthy volunteers, comparing SC injections performed by subjects using the autoinjector with SC injections performed by nurses using a syringe.Methods:This was a randomized, single-center, crossover study comparing SC self-injection using an autoinjector with SC nurse-administered injection using a syringe. Two volumes (0.2 mL and 1 mL) were injected into healthy volunteers. Study objectives included assessment of the accuracy and consistency of the volume injected by the injection systems, and skin reaction and pain associated with the injection. The fluid depot in the SC tissue layer was evaluated by ultrasound. Subject acceptance was evaluated using questionnaires on attitudes and emotions towards the injection technique, and challenged by seeking the subjects’ preferred system for a final study injection or future treatment.Results:A total of 960 injections (480 with autoinjector, 480 with syringe) were performed in 40 subjects. There were no significant differences in mean fluid leakage and injected volumes between the systems. Pain associated with the injection was significantly lower with the auto-injector than with the syringe. Local skin reaction at the injection site was overall satisfactory. Injections were appropriately performed by all subjects. At study end, all 40 subjects preferred the autoinjector for a final study injection and for future treatment.Conclusion:This study indicated that the autoinjector used by the subject was similar to a syringe used by a nurse in terms of performance and safety in administering the injections, and better in terms of pain, overall acceptance, and preference.

AimThe primary objective of this study was to evaluate the impact of fluid injection viscosity in combination with different injection volumes and flow rates on subcutaneous (SC) injection pain tolerance.MethodsThe study was a single-center, comparative, randomized, crossover, Phase I study in 24 healthy adults. Each participant received six injections in the abdomen area of either a 2 or 3 mL placebo solution, with three different fluid viscosities (1, 8–10, and 15–20 cP) combined with two different injection flow rates (0.02 and 0.3 mL/s). All injections were performed with 50 mL syringes and 27G, 6 mm needles. Perceived injection pain was assessed using a 100 mm visual analog scale (VAS) (0 mm/no pain, 100 mm/extreme pain). The location and depth of the injected fluid was assessed through 2D ultrasound echography images.ResultsViscosity levels had significant impact on perceived injection pain (P=0.0003). Specifically, less pain was associated with high viscosity (VAS =12.6 mm) than medium (VAS =16.6 mm) or low (VAS =22.1 mm) viscosities, with a significant difference between high and low viscosities (P=0.0002). Target injection volume of 2 or 3 mL was demonstrated to have no significant impact on perceived injection pain (P=0.89). Slow (0.02 mL/s) or fast (0.30 mL/s) injection rates also showed no significant impact on perceived pain during SC injection (P=0.79). In 92% of injections, the injected fluid was located exclusively in SC tissue whereas the remaining injected fluids were found located in SC and/or intradermal layers.ConclusionThe results of this study suggest that solutions of up to 3 mL and up to 15–20 cP injected into the abdomen within 10 seconds are well tolerated without pain. High viscosity injections were shown to be the most tolerated, whereas injection volume and flow rates did not impact perceived pain.

Background Major and minor tranquillisers can be used to chemically restrain a patient. Use of chemical restraint (CR) has been described mainly in long care settings but there is very limited information when considering acute care hospitals. Purpose To study the prescriptions for major and minor tranquillisers in 3 clinical wards of a French teaching hospital and to determine if they can be considered CR. Materials and Methods This prospective study took place over 2 weeks in 3 different wards: geriatrics, pneumology and vascular surgery. Tranquilizers were defined as anxiolytics (minor) and neuroleptics (major). Prescriptions were checked daily and for each patient with a tranquilliser, medical records were screened to determine whether it was newly prescribed. For every newly-prescribed tranquilliser the practitioner was asked the indication, if he considered his prescription was a CR and if the patient was being physically restrained. Results 45.2% of the 137 patients included had been prescribed at least 1 tranquilliser. 54.5% of the 77 tranquillisers prescribed were introduced during the hospitalisation. Among those 42 newlyintroduced tranquillisers, 9 (21.4%) were considered as CR by the prescribers. 6.6% of the patients included were chemically restrained, which is comparable with previous retrospective studies of restraint in acute care wards. The most frequently prescribed CR was alprazolam (55.6%) and the most frequent indication for CR was anxiety. In addition 88.9% of the CR drugs were prescribed 'when required' leaving responsibility for administration to nurses alone. None of the patients with tranquillisers had physical restraint. Conclusions This is the first prospective study on restraint in an acute care hospital. CR is used for a minority of patients; however it is mostly prescribed 'when required'. Hence it should be used with the utmost care and prescribed with the most precise instructions in order to avoid misuse and risk of abuse. Background Before infusion with a syringe pump, drug preparation requires often dilution and more steps compared to most other injection practises, thus involves risks for patients and Health Care Workers (HCWs). The literature indicates that prefilled syringes (PFSs) address these issues successfully but most data do not apply to intravenous infusions. Purpose BD ran a multicentre study to evaluate the expected impacts of a new BD Sterifill 50 ml PFS on patient and HCW safety, comparing an infusion with a syringe pump using either the PFS or a conventional system (drug in ampoule, diluent, 50 ml syringe filled at time of use). Materials and Methods 120 HCWs performed infusions in a randomised order, 4 with the new PFS, 4 with the conventional system, mimicking regular dobutamine preparation and infusion (250 mg/ 50 ml, 10 ml/h). For all 960 cases, an observer recorded any handling Background Our pharmacy department performs 150 Vitamin K antagonist (VKA) patient consultations annually. New oral anticoagulants (NOACs) are expected to replace VKAs in most of th...