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ACTIVE NOT RECRUITING
NCT04011163
PHASE2/PHASE3

Vital Signs-Integrated Patient-Assisted Intravenous Opioid Analgesia for Post Surgical Pain

Sponsor: KK Women's and Children's Hospital

View on ClinicalTrials.gov

Summary

To meet the unmet need of better and safer pain relief for acute pain in the post-operative setting, a Vital-signs-integrated Patient-assisted Intravenous opioid Analgesia ("VPIA") Delivery System, with novel and intelligent software algorithms and specialised hardware was developed. In the previous project, the investigators have shown that this system has the potential to increase the safety and patient satisfaction with intravenous opioid analgesia. However, opportunities to develop more robust vital signs monitoring with the goal of ensuring continual and effective analgesia are identified. The primary aim of this proposal is to advance the development of technology (through new features and functionality) and perform clinical evaluation of the VPIA system with a larger sample size to show improvements in patient's satisfaction (pain relief) and robustness of system in terms of vital signs integration. Novel technology using adaptive vital signs controller, integrated with an infusion pump and single finger probe vital signs monitor system will be developed with the aim for commercialisation.

Key Details

Gender

FEMALE

Age Range

21 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2021-03-31

Completion Date

2025-12-31

Last Updated

2024-10-09

Healthy Volunteers

No

Interventions

DEVICE

VPIA pump

The pump is a specially designed and manufactured infusion syringe pump for intravenous analgesia. It incorporates the VPIA study regimen to meet the specific requirements of the clinical trial. It is intended to be used only for delivering drugs intravenously.

DRUG

Morphine

Intravenous medication used is morphine diluted in normal saline to a concentration of 1mg/ml. This is a standard dilution and are routine drugs used as standard of care.

Locations (1)

KK Women's and Children's Hospital

Singapore, Singapore