Validation of Chloe SED, a Low-Cost, Reusable Syringe Extension Device for the Provision of Paracervical Analgesia [A21].

INTRODUCTION: Women in Kenya and other low- and middle-income countries often do not receive analgesia during manual vacuum aspiration (MVA). This pilot study evaluated the efficacy of a novel, ultra-low-cost syringe extension device (Chloe-SED) developed by this research team for provision of paracervical block (PCB) during MVA. METHODS: A randomized, single-blinded non-inferiority trial of 61 patients was conducted at two facilities in Kisumu between September 2019 and January 2021 comparing PCB administered with Chloe-SED to a standard spinal needle. The primary outcome was non-inferiority of pain score during uterine evacuation within a non-inferiority margin of 2 points on an 11-point visual assessment scale. Secondary outcomes included non-inferiority of pain score at 4 other time points, patient satisfaction, and provider feedback on Chloe-SED. Institutional review board approval was obtained and written consent was obtained from all participants. RESULTS: Chloe-SED showed non-inferiority of the primary outcome with mean pain score during evacuation of 3.9 (3.2-4.7) compared with spinal needle at 4.1 (3.5-4.7). Non-inferiority was shown at all time points. In one patient the syringe and device were incompatible. In one case, breakage of the finger-pad of the device after completion of PCB was noted with no injury to patient or provider. Most patients and providers expressed desire for continued use of the device to administer PCB for MVA. CONCLUSION: The Chloe SED device appears effective and desirable for administration of PCB during MVA. Further study and development of Chloe SED will allow humane pain control during MVA in regions worldwide where this previously was not possible. [ABSTRACT FROM AUTHOR]