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Parenteral Drug Administration: Routes of Administration and Devices
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Himanshu Bhattacharjee, Vivian Loveless, Laura A. Thoma
This route is a very popular for a single 24-h dose of analgesia (opioid with local anesthetic). However, extreme control has to be employed during dosing as most narcotic pain medications can cause a late onset respiratory depression when administered through this route. Often reserved for spastic cerebral palsy, intrathecally administered baclofen is done through an intrathecal pump implanted just below the skin of the stomach? with a tube connected directly to the base of the spine, where it bathes the appropriate nerves using low-dose baclofen.17 Intrathecal baclofen also carries none of the side effects, such as sedation, that typically occur with oral baclofen. It is the preferred route for long-term management of spasticity in people with cerebral palsy for whom other procedures, such as rhizotomy or orthopedic surgery, are inappropriate.
A post-market, randomized, controlled, prospective study evaluating intrathecal pain medication versus conventional medical management in the non-cancer, refractory, chronic pain population (PROSPER)
Published in Expert Review of Medical Devices, 2022
Jason E. Pope, Navdeep Jassal, Dawood Sayed, Denis Patterson, Gladstone McDowell, Anjum Bux, Phillip Lim, Eric Chang, Ali Nairizi, Samuel Grodofsky, Timothy R Deer
Patients were identified prospectively and enrolled in a parallel fashion. Once consent screening was performed and consent obtained, an intrathecal pump trial was performed, utilizing the intrathecal trial doses outlined in the PACC [2]. If the patient reported at least a 50% improvement as determined by reduction on a numerical rating scale from baseline that the investigator deemed because of the intrathecal trial, either in a hospital or outpatient setting, the patient was then randomized to intrathecal drug delivery or conventional medical management. Of note, conventional medical management encompassed any other treatment the investigator determined appropriate to treat the patient’s condition, including other forms of neuromodulation (SCS or PNS), decompressive minimally invasive surgery (percutaneous image guided lumbar decompression, or interspinous spacer or sacroiliac joint fusion), or medication and regional treatment strategies (injection or radiofrequency ablation). Subjects’ outcomes and health-care consumption were recorded at 3,6,9, and 12 months.
Six Month Interim Outcomes from SECURE: A Single arm, Multicenter, Prospective, Clinical Study on a Novel Minimally Invasive Posterior Sacroiliac Fusion Device
Published in Expert Review of Medical Devices, 2022
Aaron K. Calodney, Nomen Azeem, Patrick Buchanan, Ioannis Skaribas, Ajay Antony, Christopher Kim, George Girardi, Chau Vu, Christopher Bovinet, Rainer S. Vogel, Sean Li, Naveep Jassal, Youssef Josephson, Timothy R. Lubenow, Nicholas Girardi, Jason E. Pope
Patients with concomitant pain diagnoses such as lumbar disc disease, lumbar disc herniation, lumbar spondylolisthesis, lumbar stenosis, lumbar facet disease, lumbar radiculopathy, or lumbar vertebral body fractures were excluded from the study if these diagnoses were believed to be a major contributor to the symptomatology. Resultingly, this did not exclude subjects with prior lumbar fusion. 11 of the 69 subjects reported on in this interim analysis had a surgical history with lumbar fusion. Additionally, if radiculopathy beyond the buttocks (VAS ≥ 30 mm) was present, these patients were also excluded from the study. Other exclusion factors include a history of steroid SIJ injection within 30 days of the diagnostic injection, complete resolution of pain for 30 days or more after the diagnostic injection, any neuraxial steroid injection within 30 days of the diagnostic injection, having SIJ RFA within the past 6 months of enrollment, history of recent pelvic trauma (< 1 year), history of prior sacral or SIJ surgery, history of endometriosis, history of coccydynia, history of coccygectomy, history of pudendal neuralgia, having an active intrathecal pump therapy for pain, current systemic infection or local infection increasing the risk of surgery, and history of medications decreasing bone quality or soft tissue healing. Principle investigators at each study site were responsible for the diagnosis of sacroiliitis as well as ensuring patients are eligible for the study based on the inclusion and exclusion criteria. Of note, inclusion and exclusion criteria was similar to previously published prospective studies on minimally invasive sacroiliac fusion [20,21].