Stemming the opioid crisis: Breakthrough device from Children's National pain expert objectively measures pain and drug effects

 

WASHINGTON – Pediatric anesthesiologist Julia C. Finkel, M.D., of Children’s National Health System, once gazed into the eyes of a newborn patient perplexed about a better way to measure the effectiveness of pain treatment on one so small. Then she realized the answer was staring right back at her.

With the knowledge that pain and analgesic drugs produce an involuntary response from the pupil, Dr. Finkel developed a first-of-its-kind handheld device that produces a diagnostic measurement of pain, determines the appropriateness of pain treatment and monitors its efficacy.

Using proprietary algorithms, the non-invasive device objectively determines the type and intensity of pain a patient is experiencing so that physicians can select the correct analgesic class of drug and dosage. Once a drug is administered and takes effect, the device can then tell the physician if the dosage given is adequately controlling the patient’s pain. Though initial development of the device was geared toward premature infants, it can be used for children of any age and adults.

“Pain is very complex and it is currently the only vital sign that is not objectively measured,” says Dr. Finkel, who has more than 25 years of experience as a pediatric anesthesiologist. “The systematic problem we are facing today is that healthcare providers prescribe analgesics based on subjective self-reporting, which can often be inaccurate, rather than prescribe based on an objective measure of pain type and intensity.” To illustrate her point, Dr. Finkel continues, “A clinician would never prescribe blood pressure medicine without first taking a patient’s blood pressure.”

Dr. Finkel, who serves as director of Research and Development for Pain Medicine at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National, says that a first step in addressing the opioid crisis is providing physicians with objective, real-time data on a patient’s pain level to safely prescribe the right drug and dosage or an alternate treatment, thereby reducing the inappropriate prescribing of opioids.

The current standard of care for measuring pain is the 0-to-10 pain scale, which is based on subjective, observational and self-reporting techniques. Patients indicate their level of pain, with zero being no pain and ten being highest or most severe pain. Dr. Finkel notes that opioids are prescribed for patients who report high pain scores and are sometimes prescribed in cases where they are not appropriate. She cites the example of sciatica, a neuropathic pain sensation felt in the lower back, legs and buttocks. Sciatica pain is carried by touch fibers that do not have opioid receptors, which makes opioids an inappropriate choice for treating that pain.

Dr. Finkel adds that the current 0-to-10 pain measurement system increases the likelihood of inaccuracy, particularly in pediatric and non-verbal patients. Moreover, subjective pain scores cannot be standardized, heightening the potential for misdiagnosis, over-treatment or under-treatment.

FDA approval and device commercialization are currently being pursued. AlgometRx is one of eight devices recently selected by FDA to participate in “Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder. AlgometRx also received a Small Business Innovation Research (SBIR) grant from the National Institute on Drug Abuse.

A pain biomarker could rapidly advance both clinical practice and pain research, according to Dr. Finkel. For clinicians, the power to identify the type and magnitude of a patient’s nociception (detection of pain stimuli) would provide a much-needed scientific foundation for approaching pain. Nociception could be monitored through the course of treatment and dosing is targeted and personalized to ensure patients receive adequate pain relief while reducing side effects, she adds.

“A validated measure to show whether or not an opioid is indicated for a given patient could ease the health care system’s transition from overreliance on opioids to a more comprehensive and less harmful approach to pain management,” says Dr. Finkel.

She also notes that objective pain measurement can provide much needed help in validating complementary approaches to pain management, such as acupuncture, physical therapy, virtual reality and other non-pharmacological interventions.

Children’s National aims to make pediatric surgery more precise, less invasive and pain-free. By combining research and clinical work in the areas of imaging, bioengineering, pain medicine, immunology and personalized medicine, physicians and scientists are developing knowledge, tools and procedures that will benefit children globally. Learn more at www.childrensnational.org/innovationinstitute.

About AlgometRx, Inc. 
AlgometRx, Inc. is a start-up company founded by pediatric anesthesiologist Dr. Julia Finkel and spun out of the Sheik Zayed Institute for Pediatric Surgical Innovation at Children’s National Health System in 2015. The purpose of the company is the development and commercialization of Dr. Finkel’s breakthrough technology platform that objectively measures pain type, intensity and drug effect in real time by interpreting a patient’s pupillary responses using a handheld, non-invasive device and applying proprietary algorithms. To date, AlgometRx, Inc. has raised $2.5 million in capital and its pain measurement and precision dosing technology is currently being validated in numerous clinical trials. 

Media Contacts: Debbie Asrate | 301-244-6728