Background. Pain fellowship programs are facing unique challenges during the COVID-19 pandemic. Restrictions from state governments and the Centers for Disease Control and Prevention have resulted in a rapidly changing and evolving learning environment for todays' fellows. Innovative solutions must be sought to guarantee that proper education is maintained and to ensure the well-being of our trainees. Methods. We assembled a panel of pain program directors who serve as officers/board members of the Association of Pain Program Directors to provide guidance and formulate recommendations to pain fellowship directors nationally. This guidance is based on reviewing current changes to the Accreditation Council for Graduate Medical Education (ACGME) and American Board of Anesthesiology policies and best available evidence and expert opinion on the use of remote educational activities, research endeavors, and trainee wellness. Conclusions. The country is in the midst of an unprecedented pandemic. The impact on pain management fellowships has been severe and will likely last for months, resulting in extraordinary challenges to the administration of pain fellowship programs and the education of our fellows. Understanding revisions to ACGME policies, using technology to promote remote learning opportunities, and providing trainees with opportunities to alleviate their anxiety and encourage mental health are beneficial strategies to implement. Together, we can implement innovative solutions to help overcome these challenges.
Background: Approximately 12 million Americans are affected with cancer. Of these, 53% experience pain at all stages of cancer. Pain may remain uncontrolled despite high-dose opioid therapy, and opioids have many well-documented harmful side effects. Intranasal ketamine has been shown to be effective in controlling breakthrough noncancer pain in a double-blind randomized control trial (DBRCT) by Carr et al in 2003 as well as to help with depression in a DBRCT by Lapidus et al in 2014. We seek to obtain preliminary data on the safety, feasibility, and utility of this novel technique for the treatment of uncontrolled cancer pain.
Objective: This study aimed to obtain preliminary data via a clinical trial addressing the safety, feasibility, pharmacokinetics, and pharmacodynamics of intranasal ketamine. These initial findings will be applied to a subsequent trial to determine the effectiveness and associated toxicities of ketamine in a larger sample of cancer patients and to address the compelling need to identify new, successful management therapies for cancer pain.
Methods: This is an institutional review board- And investigational new drug-approved, prospective phase I/II trial to investigate the safety and use of intranasal ketamine in patients with uncontrolled pain related to cancer or cancer treatment. Informed consent will be obtained prior to all study procedures. All patients will be assigned to the same investigational treatment arm. After patient selection via inclusion/exclusion criteria, patients will be seen over 5 visits, with each visit conducted 2-7 days apart. Patients will be administered ketamine on visits 1-4 and monitored for 240 minutes with continuous pulse oximetry and regular blood pressure checks. Blood samples as well as patient-reported outcomes will be collected at set time points at baseline and after drug delivery. Patients will receive 10 mg intranasal ketamine on visit 1, 10 mg intravenous ketamine on visit 2, 30 mg intranasal ketamine on visit 3, and 50 mg intranasal ketamine on visit 4. On visit 5, an addition blood sample will be drawn.
Results: As of March 2019, enrollment is in progress, and a total of 7 subjects have completed the study. Enrollment is expected to be completed by April 2019. Final data analysis will commence soon after, and the results are expected to be submitted for publication in 2019.
Conclusions: If intranasal ketamine can be utilized for pain control in cancer patients, it could provide superior analgesia and better quality of life, without the risk of significant respiratory depression and constipation associated with opioid medications. These findings will be an important initial step toward testing the effectiveness of intranasal ketamine as a nonopioid medication for cancer pain and as potential maintenance outpatient therapy.
Study Objective:
The objective of our study was to determine safety and pharmacology (pharmacokinetics and preliminary efficacy) of intranasal (IN) ketamine for uncontrolled cancer-related pain.
Design:
Dose escalation clinical trial.
Setting:
Outpatient.
Patients:
Ten adult patients with uncontrolled cancer-related pain.
Intervention:
Each patient received escalating doses of ketamine over four visits, each 2–5 days apart: 10 mg IN at visit 1, 10 mg intravenous (IV) at visit 2, 30 mg IN at visit 3, and 50 mg IN at visit 4.
Measurements:
Pain was measured before and after drug administration for up to 4 h using the 11 point (0–10) Numerical Pain Rating Scale (NPRS).
Main Results:
All subjects had advanced cancer, with intractable pain, despite being on moderate dosage of opioids. There was a statistically significant reduction in median NPRS by 1.5 (1–4), 3 (2–3), and 4 (3–5) points at 60 min after receiving the medication and remained decreased by 1.5 (1–2), 2 (1–2) and 1 (1–4) points at the end of the study visit (240 min) with the 10 mg, 30 mg and 50 mg IN dosage, respectively. The median percentage of maximal pain relief being 22.5 (16.6–71.5), 65.5 (40–100), and 69.25 (50–100) for 10 mg, 30 mg and 50 mg IN dosage, respectively and 100 (75–100) with 10 mg IV dose. All side effects (nausea and feeling of unreality) resolved by the end of each study visit. No severe adverse events occurred.
Conclusion:
In this single-institution study, all dosages of IN ketamine administered in the study (10, 30, and 50 mg) provided significant pain relief for intractable cancer-related pain and were well tolerated. The 50 mg dose provided maximal pain relief without major side effects. Further study focused on repeated administration efficacy and safety for cancer-related pain is warranted.
Background. Pain fellowship programs are facing unique challenges during the COVID-19 pandemic. Restrictions by state governments and the Centers for Disease Control and Prevention have resulted in a rapidly changing and evolving learning environment for today's fellows. Innovative solutions must be sought to maintain proper education and ensure the well-being of our trainees. Methods. We assembled a panel of pain program directors who serve as officers/board members of the Association of Pain Program Directors, offering guidance and recommendations to pain fellowship directors nationwide. Panel members evaluate the best available evidence and expert opinion on use of remote and virtual platforms in clinical care, adaptability to alterations in clinic and referral management, and provide guidance on postgraduate impact. Conclusions. The country is in the midst of an unprecedented pandemic. The impact on pain management fellowships has been significant and will likely last for months, resulting in extraordinary challenges to the administration of pain fellowship programs and the education of our fellows. Several strategies will help address these challenges, including employing telehealth capabilities to continue clinical experiences and providing trainees with opportunities to continue their professional growth beyond fellowship completion. Together, we can implement innovative solutions to overcome these challenges.
Background: Radiofrequency ablation (RFA) is a denervation therapy commonly performed for pain of facet etiology. Degenerative spondylolisthesis, a malalignment of the spinal vertebrae, may be a co-existing condition contributing to pain; yet the effect of RFA on advancing listhesis is unknown. To the extent that denervating RFA may weaken paraspinal muscles that provide stability to the spine, the therapy can potentially contribute to progressive spinal instability. Methods: Single-center, prospective, observational pilot study in an interventional pain practice to test the hypothesis that RFA of painful facets in the setting of spondylolisthesis may contribute to advancement of further degenerative spondylolisthesis. Fifteen participants with pre-existing degenerative Grade I or Grade II spondylolisthesis and coexisting axial lumbar pain underwent lumbar RFA encompassing spondylolisthesis level and followed with post-RFA imaging at 12 months and beyond to measure percent change in spondylolisthesis. Results: The primary outcome was the percent advancement of spondylolisthesis per year measured on post-RFA lateral lumbar spine imaging compared with non-intervention inferred baseline advancement of 2% per very limited observational studies. Among the 15 participants enrolled, 14 completed the study (median age 66; 64.3% women; median BMI 33.5; mean follow-up time 23.9 months). The mean advancement of spondylolisthesis per year after RFA was 1.30% (95% CI −0.14 to 2.78%), with 9/14 below 1.25%. Conclusion: Among patients with lumbar pain originating from facets in the setting of degenerative spondylolisthesis who underwent lumbar RFA, the observed advancement of spondylolisthesis is clinically similar to the estimated maximum baseline of 2% per year change. The study findings did not find a destabilizing effect of lumbar RFA in advancing spondylolisthesis in this patient population.
by
Sayed E. Wahezi;
Lynn R. Kohan;
Boris Spektor;
Scott Brancolini;
Trent Emerick;
Jean M. Fronterhouse;
Markus M. Luedi;
Marc A. Colon;
Paul M. Kitei;
Magdalena Anitescu;
Nicholas E. Goeders;
Shilpavedi Patil;
Harish Siddaiah;
Elyse M. Cornett;
Richard D. Urman;
Alan D. Kaye
Telemedicine is the medical practice of caring for and treating patients remotely. With the spread of the coronavirus disease-2019 (COVID-19) pandemic, telemedicine has become increasingly prevalent. Although telemedicine was already in practice before the 2020 pandemic, the internet, smartphones, computers, and video-conferencing tools have made telemedicine easily accessible and available to almost everyone. However, there are also new challenges that health care providers may not be prepared for, including treating and diagnosing patients without physical contact. Physician adoption also depends upon reimbursement and education to improve the telemedicine visits. We review current trends involving telemedicine, how pandemics such as COVID-19 affect the remote treatment of patients, and key concepts important to healthcare providers who practice telemedicine.