Comparative evaluation of a novel syringe versus a hypodermic syringe in real-world settings: an open-label, single-centre, randomised controlled trial

Objective Aspiration prior to injection can be challenging due to the poor ergonomics and patient discomfort associated with hypodermic syringes. Additionally, aspiration with hypodermic syringes may yield false-negative results, increasing the risk of inadvertent intravascular injection. This study compares a novel syringe featuring a dedicated aspiration channel with a hypodermic syringe, focusing on patient-reported pain and healthcare practitioner-reported ease of use. Design Single-centre, open-label, randomised controlled trial. Settings Conducted at a tertiary care hospital in Gujarat, India, from 15 October 2024 to 15 December 2024. Participants 384 patients (192 per group) needing parenteral injections were randomised to receive injections using either the novel or hypodermic syringe. 30 patients received an additional second dose in a crossover design. 64 healthcare professionals (HCPs) performed injections with both devices. Intervention Participants received vaccines, vitamins, analgesics or regional anaesthesia using either the novel syringe or a hypodermic syringe. Main outcome measures Primary outcomes included patient pain (Present Pain Index, PPI) and HCP-rated ease of injection and aspiration. Results Patients reported minimal pain, with no significant difference between groups (mean PPI: 1.41±0.50, p>0.05). No significant difference was found in injection ease (p=0.083). The novel syringe improved aspiration ease (p<0.05); 100% of HCPs rated it ‘effortless’ vs 67% and 33% rating the hypodermic syringe as ‘moderate’ and ‘significant’. Conclusions The novel syringe improved aspiration ease and could help reduce false negative results and accidental intravascular injections, especially with drugs carrying high systemic toxicity risks. Trial registration number CTRI/2024/10/074881.