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CLINICAL TRIAL article

Front. Pain Res.
Sec. Clinical Trials, Methods, and Evidence Synthesis
Volume 5 - 2024 | doi: 10.3389/fpain.2024.1326772

Validation of a novel medical device (Chloe SED ® ) for administration of analgesia during manual vacuum aspiration: A randomized controlled non-inferiority pilot study

Provisionally accepted
Aparna Ramanathan Aparna Ramanathan 1,2Karlheinz Samenjo Karlheinz Samenjo 2,3*Robert Bailey Robert Bailey 2,4Javan Imbamba Javan Imbamba 2Stella Odenyo Stella Odenyo 2,5Erin Koksal Erin Koksal 6Jan Carel Diehl Jan Carel Diehl 3Jackton Omoto Jackton Omoto 7Stephen Gwer Stephen Gwer 2,7
  • 1 MedStar Washington Hospital Center, Washington D.C., United States
  • 2 Nyanza Reproductive Health Society, Kisumu, Kenya
  • 3 Delft University of Technology, Delft, Netherlands
  • 4 School of Public Health, University of Illinois at Chicago, Chicago, Illinois, United States
  • 5 Maseno University, Maseno, Kenya
  • 6 Independent researcher, Cambridge, United States
  • 7 School of Medicine, Maseno University, Maseno, Kisumu, Kenya

The final, formatted version of the article will be published soon.

    Millions of women worldwide annually undergo manual vacuum aspiration (MVA) with no pain medication, which is a violation of their basic human dignity. We designed a novel device (Chloe SED ® ) to administer paracervical block (PCB) during MVA in countries where pain medication is not typically given due to the high cost of necessary tools. We conducted a singleblinded, randomized controlled noninferiority trial including 61 patients at two hospitals in Kisumu, Kenya to validate Chloe SED ® for administration of PCB during MVA. PCB administered with Chloe SED ® was compared to PCB administered with a standard spinal needle.Patients requiring MVA were block randomized in blocks of six, each provider completing six PCBs -three with the Chloe SED ® and three with the standard spinal needle. The trial was registered with the Kenya Pharmacy and Poisons Board, ECCT/19/03/01: https://ctr.pharmacyboardkenya.org/applications/index/protocol_no:RUNDVC8xOS8wMy8wM Q__/filter:/investigator:/sites:/pages:5/start_date:/end_date:/disease_condition:/users:/ercs:/stages. An intention-to-treat analysis was completed. The primary outcome was non-inferiority of pain score during uterine evacuation with a non-inferiority margin of 2 points on an 11-point numerical rating scale. Secondary outcomes included non-inferiority of pain score at 4 other time points and patient satisfaction. Chloe SED ® showed non-inferiority of the primary outcome with mean pain score during evacuation of 3.8 (95% CI: 3.1, 4.6) compared with spinal needle at 4.1 (95% CI: 3.5, 4.7). Non-inferiority in pain score was shown at all time points. Most patients expressed desire for continued use of the device to administer PCB for MVA. No adverse events were noted. In summary, the Chloe SED ® appears non-inferior to the spinal needle and desirable for administration of PCB during MVA.

    Keywords: Paracervical block, Safe abortion, Anesthesia, Human Rights, miscarriage, novel technology, Clinical Trial, syringe extension device

    Received: 19 Apr 2024; Accepted: 22 Aug 2024.

    Copyright: © 2024 Ramanathan, Samenjo, Bailey, Imbamba, Odenyo, Koksal, Diehl, Omoto and Gwer. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Karlheinz Samenjo, Delft University of Technology, Delft, 2628 CD, Netherlands

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.