3-day fentanyl transdermal patch / Generic mfg. - LARVOL DELTA

Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine (clinicaltrials.gov) - P4 | N=46 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Initiation date: May 2025 ➔ Aug 2025

Trial initiation date • Pain • Substance Abuse

Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine (clinicaltrials.gov) - P4 | N=46 | Recruiting | Sponsor: University of North Carolina, Chapel Hill | Not yet recruiting ➔ Recruiting

Enrollment open • Pain • Substance Abuse

Comparison of Two Intravenous Drug Combinations for Ambulatory Oral & Maxillofacial Surgery (clinicaltrials.gov) - P1 | N=73 | Completed | Sponsor: Albert Einstein College of Medicine

New P1 trial • Anesthesia

Aveva Drug Delivery Systems Launches Generic Fentanyl TDS, it's Third Successful Complex Transdermal Drug Product Launch in 15 Months (PRNewswire) - "Aveva Drug Delivery systems...is proud to announce the launch of all strengths of its generic Fentanyl Transdermal Patch in the US market. The launch of Fentanyl TDS, a prescription 3-day transdermal patch for managing moderate to severe chronic pain (generic equivalent to Duragesic), required the rapid sourcing and seamless integration of advanced manufacturing equipment's with existing systems to meet regulatory and operational standards. The Fentanyl TDS patch with reported US sales of USD 182 Mn is an extended-release opioid analgesic intended for around-the-clock pain management in patients who require long-term opioid treatment."

Launch US • Pain

Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine (clinicaltrials.gov) - P4 | N=46 | Not yet recruiting | Sponsor: University of North Carolina, Chapel Hill

New P4 trial • Pain • Substance Abuse

Paravertebral Nerve Blocks in Neonates (clinicaltrials.gov) - P4 | N=16 | Terminated | Sponsor: Emory University | N=30 ➔ 16 | Recruiting ➔ Terminated; The study activities were suspended due to COVID-19, and the interim analysis did not yield positive results once resumed.

Enrollment change • Trial termination • Cardiovascular • Heart Failure

NCI-2018-01124: Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery (clinicaltrials.gov) - P3 | N=96 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2024 ➔ Jul 2026 | Trial primary completion date: Aug 2023 ➔ Jul 2026

Surgery • Trial completion date • Trial primary completion date • Hepatology • Pain

Compare Propofol to Fentanyl and Midazolam for Colonoscopy (clinicaltrials.gov) - P=N/A | N=289 | Completed | Sponsor: Saint Joseph Mercy Health System | Unknown status ➔ Completed

Trial completion • Colon Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Oncology • Rectal Cancer • Solid Tumor

NCI-2018-01124: Thoracic Epidural Analgesia or Four-Quadrant Transversus Abdominus Plane Block in Reducing Pain in Patients Undergoing Liver Surgery (clinicaltrials.gov) - P3 | N=96 | Recruiting | Sponsor: M.D. Anderson Cancer Center | Trial completion date: Aug 2023 ➔ Aug 2024 | Trial primary completion date: Aug 2022 ➔ Aug 2023

Surgery • Trial completion date • Trial primary completion date • Hepatology • Pain

Paravertebral Nerve Blocks in Neonates (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Emory University | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ Dec 2024

Trial completion date • Trial primary completion date • Cardiovascular • Heart Failure

Paravertebral Nerve Blocks in Neonates (clinicaltrials.gov) - P4 | N=30 | Recruiting | Sponsor: Emory University | Suspended ➔ Recruiting

Enrollment open • Cardiovascular • Heart Failure

Paravertebral Nerve Blocks in Neonates (clinicaltrials.gov) - P4; N=30; Suspended; Sponsor: Emory University; Trial completion date: Dec 2020 ➔ Dec 2022; Trial primary completion date: Dec 2020 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Cardiovascular • Heart Failure

Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy (clinicaltrials.gov) - P3; N=79; Completed; Sponsor: Vanderbilt-Ingram Cancer Center; Active, not recruiting ➔ Completed

Clinical • Trial completion • Head and Neck Cancer • Mucositis • Oncology • Solid Tumor

The pharmacokinetics of a fentanyl matrix patch applied at three different anatomical locations in horses. (PubMed, Equine Vet J) - "Fentanyl was rapidly absorbed and persisted in the plasma for up to 96 hours. No adverse effects of treatment on HR, RR, or RT were observed. Further controlled prospective studies are needed to determine what plasma concentration, if any, of fentanyl achieves an analgesic effect in horses when administered via a transdermal patch system."

Journal • PK/PD data • Pain

Enhancing Nonfouling and Sensitivity of Surface-Enhanced Raman Scattering Substrates for Potent Drug Analysis in Blood Plasma via Fabrication of a Flexible Plasmonic Patch. (PubMed, Anal Chem) - "The fentanyl concentration calculated in the patients' blood plasma from SERS analysis is in excellent agreement with the values determined using the paper spray ionization mass spectrometry technique. We believe that the flexible plasmonic patch fabrication strategy would be widely applicable to any plasmonic nanostructure for SERS-based chemical sensing for clinical toxicology and therapeutic drug monitoring."

Journal

"LOL. That reminds me I need to google is Limbaugh dead yet or at least on fentanyl patch😺" (@Tgollum)

Patterns of Routes of Administration and Drug Tampering for Nonmedical Opioid Consumption: Data Mining and Content Analysis of Reddit Discussions. (PubMed, J Med Internet Res) - "This work investigated some important consumption-related aspects of the opioid epidemic using Reddit data. We believe that our approach may provide a novel perspective for a more comprehensive understanding of nonmedical abuse of opioids substances and inform the prevention, treatment, and control of the public health effects."

Journal • Immunology

Microinduction of Buprenorphine/Naloxone: A Review of the Literature. (PubMed, Am J Addict) - "This manuscript provides a review of the existing literature to help clinicians better understand the approaches to microdosing of buprenorphine in various clinical settings and populations. (Am J Addict 2020;00:00-00)."

Journal • Review • Addiction (Opioid and Alcohol) • Pain

[VIRTUAL] Evaluation of the appropriateness of fentanyl patch use in the inpatient setting (ASHP 2020) - "Primary endpoints are the appropriateness of fentanyl dose initiation and titration. Secondary endpoints include appropriate indication, concomitant opioid use (for bridging), safety events (i.e., naloxone administration, rapid response team call) associated with the use of fentanyl, and prescribing patterns between disciplines."

Clinical

[VIRTUAL] Analysis of opioid-related harms associated with inpatient fentanyl patch administration (ASHP 2020) - "Several patterns of risk were identified including: (1) Fentanyl patch use in a patient that is not opioid tolerant [taking >/= 60MME for >/= 7 days]; (2) Incorrect patch strength selection for first-time patch patient; (3) Incorrect patch strength selection for patch dosage increases; (4) Inappropriately shortened trial period of up titrated fentanyl patch strength; (5) Use of every 48 hour dosing interval rather than every 72 hour dosing interval; (6) Patch dose decrease occurring prior to the patient’s next scheduled change date, inadvertently increasing the patient’s opioid dose; (7) Lack of documentation/reporting of previous adverse effects or hypersensitivities to fentanyl patch; (8) Overestimation of appropriate fentanyl patch dose respective to patient’s history of adverse events; (9) Inconsistent dosing and administration times of fentanyl patch; (10) Presence of a drug-drug interaction with a CYP3A4 inhibitor; (11) Concomitant opioid and sedative..."

Clinical • Addiction (Opioid and Alcohol) • Cardiovascular • Gastroenterology • Geriatric Disorders • Hepatology • Immunology • Liver Failure • Nephrology • Oncology • Renal Disease • Respiratory Diseases • Solid Tumor

[VIRTUAL] The impact of pharmacy provided in-services on ketorolac and opioid utilization in the emergency department in a community teaching hospital (ASHP 2020) - "Patients treated for chronic pain, as indicated by home usage of fentanyl patches or long acting opioids, will be excluded. The study protocol will be submitted for IRB approval prior to initiation. Results will be presented to the Pharmacy and Therapeutics Committee."

Clinical • Pain

[VIRTUAL] Evaluation of fentanyl patch utilization in cancer patients with compromised renal function (ASHP 2020) - "A comparison was made of therapy duration, patient pain scores, and quality of life (QoL) outcomes between the two groups. The Wilcoxon sign-rank statistical test was utilized to analyze the difference between two groups on pain intensity prior to and post fentanyl patch administration for each individual."

Clinical • CNS Disorders • Depression • Oncology • Pain • Palliative care • Psychiatry • CYP3A4

[VIRTUAL] Evaluation of transdermal fentanyl patch utilization in a community hospital setting (ASHP 2020) - "Patients receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or the equianalgesic dose of another opioid are determined to be opioid tolerant. Data will be collected on baseline demographics, indication for fentanyl patch, prescriber specialty, documented adverse effects, administration of naloxone, nursing documentation of fentanyl patch application and removal, and concomitant administration of other central nervous system depressants, such as benzodiazepines, skeletal muscle relaxants, and other opioids."

Clinical • CNS Disorders • Depression • Pain • Psychiatry

[VIRTUAL] Evaluate Awareness level About Handling , Disposal and Safe Use of Fentanyl Patch Among Patients or Their Caregivers in Outpatient Setting. (ASHP 2020) - "There were a large proportion of patients who improperly and unsafely use, store, and dispose of fentanyl patches. Raising the level of awareness for the proper use of fentanyl patches and ensures adequate counselling from healthcare providers are of high priority for better treatment outcome and patient safety."

Clinical • Addiction (Opioid and Alcohol) • Pain

Deficiencies with the Use of Prescription Drug Monitoring Program in Cancer Pain Management: A Report of Two Cases. (PubMed, J Palliat Med) - "The PDMP erroneously reported that he had filled methadone, thereby impacting the provider-patient relationship...The patient was wearing a fentanyl patch that was found only on physical examination during a clinic visit, because it was not noted in the PDMP...Enhanced real-time reporting of opioid prescribing information, increased integration into electronic health systems, and universal interstate sharing of prescribing data are some of the ways to improve their effectiveness. More research is needed to further examine the deficiencies and improve on its utility in routine chronic opioid therapy."

Clinical • Journal • Lung Cancer • Oncology • Pain • Solid Tumor