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1.  Fentanyl Iontophoretic Transdermal System (IONSYS®) can be Safely used in the Hospital Environment with X-Rays, Computerized Tomography and Radiofrequency Identification Devices 
Advances in Therapy  2016;33(9):1649-1659.
Fentanyl iontophoretic transdermal system (fentanyl ITS, IONSYS®) is a patient-controlled analgesia system used for the management of acute postoperative pain, designed to be utilized in a hospital setting. The objective of the two studies was to determine if fentanyl ITS could be safely used with X-rays, computerized tomography (CT) scans and radiofrequency identification (RFID) devices.
The ITS system has two components: controller and drug unit; the studies utilized ITS systems without fentanyl, referred to as the ITS Placebo system. The first study evaluated the effect of X-radiation on the operation of an ITS Placebo system. Five ITS Placebo systems were exposed to X-rays (20 and 200 mSv total radiation dose—the 200 mSv radiation dose represents a tenfold higher exposure than in clinical practice) while operating in the Ready Mode and five were exposed while operating in the Dose Mode. The second study evaluated the effect of RFID (worst-case scenario of direct contact with an RFID transmitter) on the operation of an ITS Placebo system. During these tests, observations of the user interface and measurements of output voltage confirmed proper function throughout all operational modes (Ready Mode, Dose Mode, End-of-Use Mode, and End-of-Life Mode).
The ITS Placebo system met all specifications and no functional anomalies were observed during and following X-ray exposure at two radiation dose levels or exposure at six different combinations of RFID frequencies and field strengths.
The performance of the ITS system was unaffected by X-ray exposure levels well beyond those associated with diagnostic X-rays and CT scans, and by exposure to radiofrequency field strengths typically generated by RFID devices. These results provide added confidence to clinicians that the fentanyl ITS system does not need to be removed during diagnostic X-rays and CT scans and can also be utilized in close proximity to RFID devices.
The studies and writing of this manuscript were supported financially by The Medicines Company.
PMCID: PMC5020125  PMID: 27423647
CT scan; Electromagnetic immunity; Fentanyl; IONSYS; Iontophoretic transdermal system; Patient-controlled analgesia; RFID; X-ray
2.  The Efficacy and Safety of the Fentanyl Iontophoretic Transdermal System (IONSYS®) in the Geriatric Population: Results of a Meta-Analysis of Phase III and IIIb Trials 
Drugs & Aging  2016;33(12):901-912.
Background and Objectives
Acute postoperative pain management in the geriatric patient can be challenging, including their response to medications. The purpose of this analysis was to evaluate whether the efficacy and safety profile of fentanyl iontophoretic transdermal system (ITS) (IONSYS®) was similar in geriatric (≥65 years) and non-geriatric (<65 years) patients.
Efficacy and safety data from three randomized, double-blind, placebo-controlled trials and four randomized, open-label, active-comparator trials were utilized for this analysis. Efficacy was assessed via the patient global assessment (PGA) and the investigator global assessment (IGA) scales. The PGA and IGA are categorical 4-point scales (excellent, good, fair, or poor) with treatment success defined as excellent or good. Safety was evaluated via adverse events.
A total of 1763 patients were assigned to the fentanyl ITS treatment group. Of the 1763 patients in the fentanyl ITS group, 499 patients were ≥65 years of age; 65.1% were 65–74 years of age, 31.7% were 75–84 years of age, and 3.2% were ≥85 years of age. In the fentanyl ITS treatment groups, there were no statistically significant differences between the non-geriatric and geriatric patients in terms of patients reporting success on the PGA at 24 h (80.0 vs. 83.0%, respectively; p = 0.3415). There were no statistically significant differences between the groups in success rates on the IGA at study discharge (82.8 vs. 87.5%, respectively; p = 0.1195). The safety profile was similar between the age groups.
Overall, efficacy and safety of the fentanyl ITS were similar between the geriatric and non-geriatric patients.
PMCID: PMC5122621  PMID: 27785733
4.  Efficacy and Safety of Methylnaltrexone for Opioid-Induced Constipation in Patients With Chronic Noncancer Pain 
Background and Objectives
In patients with chronic noncancer pain, subcutaneous methylnaltrexone for opioid-induced constipation (OIC) was examined in a randomized controlled trial (RCT) followed by an open-label extension (OLE). This study examined the reproducibility of RCT findings by analyzing data from placebo-treated patients who crossed over to methylnaltrexone.
Adults with less than 3 weekly rescue-free bowel movements (RFBMs), taking 50 mg or more of an oral morphine equivalent per day, were randomized to receive methylnaltrexone 12 mg or placebo for 4 weeks, followed by open-label methylnaltrexone 12 mg as needed for 8 weeks.
A total of 134 placebo-treated patients (median morphine equivalent dose, 150 mg/d; mean of 1.1 RFBM per week) crossed over to methylnaltrexone in OLE. During the RCT, 9.7% of placebo-treated patients experienced an RFBM within 4 hours of first dose and 9.0% of all placebo injections resulted in an RFBM within 4 hours compared with 45.9% and 34.5%, respectively, with methylnaltrexone treatment in the OLE. When expressed as percentage of patients experiencing 3 or more RFBMs per week and a 1-RFBM increase over baseline, weekly values ranged from 35% to 40% during placebo treatment; at week 5 of OLE methylnaltrexone, this percentage increased to more than 70% and remained relatively stable throughout the OLE. The most common adverse events during methylnaltrexone treatment were abdominal pain (9.7% vs 1.5% for placebo) and nausea (5.2% vs 6.7%).
Findings during placebo treatment further establish the profile of OIC and support that little or no gastrointestinal tolerance develops across time. Findings under open-label conditions established the reproducibility and durability of methylnaltrexone for OIC.
PMCID: PMC4684250  PMID: 26650429
5.  Is Neuraxial Anesthesia Safe in Patients Undergoing Surgery for Treatment of Periprosthetic Joint Infection? 
There is concern that neuraxial anesthesia in patients undergoing surgery for treatment of a periprosthetic joint infection (PJI) may increase the risk of having a central nervous system infection develop. However, the available data on this topic are limited and contradictory.
We wished to determine whether neuraxial anesthesia (1) is associated with central nervous system infections in patients undergoing surgery for a PJI, and (2) increases the likelihood of systemic infection in these patients.
All 539 patients who received neuraxial or general anesthesia during 1499 surgeries for PJI from October 2000 to May 2013 were included in this study; of these, 51% (n = 764) of the surgeries were performed in 134 patients receiving neuraxial anesthesia and 49% were performed in 143 patients receiving general anesthesia. Two hundred sixty-two patients received general and neuraxial anesthesia during different surgeries. We used the International Classification of Diseases, 9th Revision codes and the medical records to identify patients who had an intraspinal abscess or meningitis develop after surgery for a PJI. Multivariate analysis was used to assess the effect of type of anesthesia (neuraxial versus general) on postoperative complications.
There were no cases of meningitis, but one epidural abscess developed in a patient after neuraxial anesthesia. This patient underwent six revision surgeries during a 42-day period. Patients who received neuraxial anesthesia had lower odds of systemic infections (4% versus 12%; odds ratio, 0.35; 95% CI, 023–054; p < 0.001).
Central nervous system infections after neuraxial anesthesia in patients with a PJI appear to be exceedingly rare. Based on the findings of this study, it may be time for the anesthesiology community to reevaluate the risk of sepsis as a relative contraindication to the use of neuraxial anesthesia.
Level of Evidence
Level III, therapeutic study.
PMCID: PMC4353555  PMID: 25670655
6.  Perioperative Management of Interscalene Block in Patients with Lung Disease 
Case Reports in Anesthesiology  2013;2013:986386.
Interscalene nerve block impairs ipsilateral lung function and is relatively contraindicated for patients with lung impairment. We present a case of an 89-year-old female smoker with prior left lung lower lobectomy and mild to moderate lung disease who presented for right shoulder arthroplasty and insisted on regional anesthesia. The patient received a multimodal perioperative regimen that consisted of a continuous interscalene block, acetaminophen, ketorolac, and opioids. Surgery proceeded uneventfully and postoperative analgesia was excellent. Pulmonary physiology and management of these patients will be discussed. A risk/benefit discussion should occur with patients having impaired lung function before performance of interscalene blocks. In this particular patient with mild to moderate disease, analgesia was well managed through a multimodal approach including a continuous interscalene block, and close monitoring of respiratory status took place throughout the perioperative period, leading to a successful outcome.
PMCID: PMC3863477  PMID: 24369510
7.  Randomized placebo-controlled study of intravenous methylnaltrexone in postoperative ileus 
Journal of Drug Assessment  2013;2(1):127-134.
This phase 2 study evaluated the safety and activity of intravenous methylnaltrexone on the duration of postoperative ileus in patients undergoing segmental colectomy.
Adults (aged 18 years or older) with American Society of Anesthesiologists physical status of I, II, or III who underwent segmental colectomy, including partial colectomy, sigmoidectomy, cecectomy, or anterior proctosigmoidectomy, via laparotomy with general anesthesia, received intravenous methylnaltrexone 0.30 mg/kg or placebo every 6 h beginning within 90 min after end of surgery. Treatment continued until 24 h after the patient tolerated solid foods, was discharged, or for 7 d maximum. Efficacy endpoints included measures of gastrointestinal recovery and time to discharge eligibility.
A total of 65 patients (methylnaltrexone, n = 33; placebo, n = 32) were randomized. Mean time to first bowel movement was accelerated by 20 h (p = 0.038) and time to discharge eligibility was accelerated by 33 h (p = 0.049) with methylnaltrexone vs placebo. Opioid use was similar between groups until postoperative day 4, then fluctuated in the placebo group. Methylnaltrexone was generally well tolerated.
In this study, intravenous methylnaltrexone significantly decreased time to postoperative bowel recovery and eligibility for hospital discharge by ∼1 d, with an adverse event profile similar to placebo. These were two of several exploratory endpoints; not all efficacy endpoints showed a significant difference between methylnaltrexone and placebo. The efficacy results in this trial were not seen in two subsequent large-scale studies.
PMCID: PMC4937649  PMID: 27536446
Methylnaltrexone; Postoperative ileus; Opioids; Mu-opioid receptor antagonist
8.  Lessons Learned with Extended-release Epidural Morphine after Total Hip Arthroplasty 
An extended-release epidural morphine (EREM) has been introduced to improve postoperative pain management. Studies have shown the effectiveness of this agent in providing better pain control and patient satisfaction for patients undergoing total joint arthroplasty. We evaluated postoperative pain relief by comparing average daily pain scores and opioid use with those of the control group. Safety was measured by comparing the occurrence of postoperative complications, nausea and vomiting, pruritus, and respiratory depression between the two groups. Between February 2006 and March 2008, we selected 203 patients to receive EREM for THA. These patients were matched in a 2:1 ratio with patients undergoing THA and receiving spinal anesthesia. We retrospectively reviewed all major and minor postoperative complications from a prospective database. Patients receiving EREM had lower pain scores than patients not receiving EREM on Postoperative Day 1 (POD 1) but not POD 2, or POD 3. Patients receiving EREM experienced a slightly higher incidence of pulmonary embolism and supraventricular tachycardia. Patients receiving EREM also experienced more nausea and vomiting and pruritus. We found EREM provided better pain relief on POD 1 at the expense of a slightly higher incidence of side effects compared with spinal anesthesia alone.
Level of Evidence: Level III, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.
PMCID: PMC2835616  PMID: 20012719
9.  Anesthetic Routines: The Anesthesiologist's Role in GI Recovery and Postoperative Ileus 
All patients undergoing bowel resection experience postoperative ileus, a transient cessation of bowel motility that prevents effective transit of intestinal contents or tolerance of oral intake, to varying degrees. An anesthesiologist plays a critical role, not only in the initiation of surgical anesthesia, but also with the selection and transition to effective postoperative analgesia regimens. Attempts to reduce the duration of postoperative ileus have prompted the study of various preoperative, perioperative, and postoperative regimens to facilitate gastrointestinal recovery. These include modifiable variables such as epidural anesthesia and analgesia, opioid-sparing anesthesia and analgesia, fluid restriction, colloid versus crystalloid combinations, prokinetic drugs, and use of the new peripherally acting mu-opioid receptor (PAM-OR) antagonists. Review and appropriate adaptation of these multiple modifiable interventions by anesthesiologists and their surgical colleagues will facilitate implementation of a best-practice management routine for bowel resection procedures that will benefit the patient and the healthcare system.
PMCID: PMC3168940  PMID: 21991449
10.  Alvimopan for the Management of Postoperative Ileus After Bowel Resection: Characterization of Clinical Benefit by Pooled Responder Analysis 
World Journal of Surgery  2010;34(9):2185-2190.
A pooled post hoc responder analysis was performed to assess the clinical benefit of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, for the management of postoperative ileus after bowel resection.
Adult patients who underwent laparotomy for bowel resection scheduled for opioid-based intravenous patient-controlled analgesia received oral alvimopan or placebo preoperatively and twice daily postoperatively until hospital discharge or for 7 postoperative days. The proportion of responders and numbers needed to treat (NNT) were examined on postoperative days (POD) 3–8 for GI-2 recovery (first bowel movement, toleration of solid food) and hospital discharge order (DCO) written.
Alvimopan significantly increased the proportion of patients with GI-2 recovery and DCO written by each POD (P < 0.001 for all). More patients who received alvimopan achieved GI-2 recovery on or before POD 5 (alvimopan, 80%; placebo, 66%) and DCO written before POD 7 (alvimopan, 87%; placebo, 72%), with corresponding NNTs equal to 7.
On each POD analyzed, alvimopan significantly increased the proportion of patients who achieved GI-2 recovery and DCO written versus placebo and was associated with relatively low NNTs. The results of these analyses provide additional characterization and support for the overall clinical benefit of alvimopan in patients undergoing bowel resection.
PMCID: PMC2917559  PMID: 20526599

Results 1-10 (10)