Dataset for: Comparative Evaluation of a Novel Syringe Versus a Hypodermic Syringe in Real-World Settings: An Open-Label, Single-Centre, Randomised Controlled Trial
Description
Study Title: Comparative evaluation of a novel syringe versus a hypodermic syringe in real-world settings: an open-label, single-centre, randomised controlled trial. Description: This dataset contains de-identified individual participant data (IPD) and supporting materials from a single-centre, open-label, randomised controlled trial conducted at a tertiary care hospital in Gujarat, India. The trial compared a CDSCO-approved novel syringe—featuring a separate aspiration channel—with a regular hypodermic syringe in terms of patient-reported pain and healthcare practitioner (HCP)-rated ease of injection and aspiration. Participants included 384 patients (192 per group) and 64 HCPs, with an additional 30 patients enrolled in a crossover phase. Pain was assessed using the Present Pain Index (PPI), while HCPs rated ease of use during injection and aspiration procedures. The trial was registered with the Clinical Trials Registry – India (CTRI/2024/10/074881). Main findings include: No significant difference in pain perception between groups. Both syringes were rated similarly for injection ease. The novel syringe was rated as “effortless” for aspiration by 100% of HCPs, while the standard syringe required moderate or significant effort (p < 0.001). No adverse events were reported. This dataset includes: De-identified individual participant data (CSV) Study Protocol (PDF) Informed Consent Form template (PDF) Clinical Study Report (PDF) Data Availability: Data will be available starting 9 months and ending 36 months after article publication. Access is granted to researchers who submit a methodologically sound proposal. To request access, contact the corresponding author. License: This dataset is shared under a CC BY-NC-ND 4.0 license. This permits others to download the data and share it with attribution, but not to use it commercially or create derivative works. Citation: Please cite the corresponding publication when using this dataset: Author(s). Title. Journal. Year. DOI (to be added once available).
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Institutions
- BJ Medical CollegeGujarat, Ahmedabad