This is a letter I received from the ASA 

Dear Fellow ASA members  

It is with great pride that I announce that the National Anesthesia Clinical Outcomes Registry (NACOR), maintained for our specialty by the Anesthesia Quality Institute (AQI), has been designated by the Centers for Medicare and Medicaid Services (CMS) as a Qualified Clinical Data Registry (QCDR). A QCDR is a new mechanism to report physician performance.  NACOR was among the first 40 registries to receive the QCDR designation. This designation will have significant implications for our specialty. 

In the next five years, CMS will phase out claims-based reporting in favor of registry-based reporting.  With this change, responsibility for measure development, data collection and reporting will move from CMS to specialty society registries like AQI/NACOR.

The most important aspect of the QCDR designation is that it allows ASA to select and develop its own measures. Previously, physician anesthesiologists were limited to reporting three measures to the Physician Quality Reporting System (PQRS). Now we can use more than a dozen additional anesthesia-related measures through the QCDR option to meet the evolving federal requirements. Further, we will have the ability to add additional measures in coming years, to cover subspecialty areas and related disciplines such as pain medicine and critical care. The goal is to enable every physician anesthesiologist to readily report on outcomes that matter to them and their patients.  

New QCDR Registry Measures include:

•Post-anesthestic transfer of care: Use of checklist or protocol for direct transfer of care from procedure room to Intensive Care Unit (ICU)

•Post-anesthestic transfer of care measure – procedure room to post-anesthesia care unit

•Prevention of post-operative nausea and vomiting – combination therapy (adults)

•Prevention  of post-operative vomiting – combination therapy (pediatrics)

•Composite anesthesia safety

•Immediate perioperative cardiac arrest rate

•Immediate perioperative mortality rate

•PACU reintubation rate 

•Short-term pain management

•Composite procedural safety for central line placement

•Composite patient experience measure

The QCDR option has far-reaching implications regarding how physician anesthesiologists receive the 2014 payment bonus or incentive of 0.5 percent. It will also impact physician anesthesiologists who fail to successfully report after 2015 with payment penalties starting at 1.5 percent and increasing steadily afterwards.

This new reporting vehicle will transform how physician anesthesiologists participate in PQRS. It will also significantly change how measures impacting patients, physician anesthesiologists and other providers are developed, tested and ultimately used to improve patient care and safety. 

More information about performance reporting and the QCDR mechanism is available atwww.aqihq.org/PQRSReporting.aspx. 

Practices wishing to use NACOR and the QCDR mechanism to report performance in 2014 should notify Lance Mueller, director of the Anesthesia Quality Institute (AQI), atl.mueller@asahq.org or call (847) 825-5586, ext. 190.

Jane C. K. Fitch, M.D.

2014 President

American Society of Anesthesiologists

Published in JAMA Psychiatry April 16, 2014

The first evidence from a randomized clinical trial that the anesthetic agent ketamine may provide rapid symptom reduction in patients with chronic posttraumatic stress disorder (PTSD) when delivered intravenously has been published.

An N-methyl-D-asparate (NMDA) glutamate receptor, ketamine has made headlines in recent years because several trials conducted by investigators at the Icahn School of Medicine at Mount Sinai in New York City have shown that it delivers a rapid antidepressant effect when delivered intravenously and, most recently, intranasally in spray form.

In this latest proof-of-concept study, researchers led by Adriana Feder, MD, found that intravenous (IV) infusion of ketamine hydrochloride (0.5 mg/kg) was associated with significant and rapid reduction of PTSD symptom severity compared with an active control agent.

“These findings may lead to novel approaches in the treatment of chronic PTSD ? a condition that affects a broad spectrum of adults in the United States and beyond, including victims of sexual assault, war veterans, those who have witnessed catastrophic events such as the September 11 terror attacks, and others,” Dr. Feder, associate professor of psychiatry, Icahn School of Medicine at Mount Sinai, said in a release.

“However, this should be viewed as a proof-of-concept study. Additionally, longer-term clinical trials with ketamine will be required to determine if it will be a clinically useful treatment for PTSD,” she added.

Fast-Acting Antidepressant

Few pharmacotherapies have demonstrated sufficient efficacy in the treatment of PTSD, which is chronic and disabling, the investigators note.

They add that there is a growing body of evidence showing that glutamate plays a major role in mediating stress response, the formation of traumatic memories, and PTSD pathophysiology.

An agent that has been used for anesthesia at 2 mg/kg and analgesia at subanesthetic doses, ketamine has a good safety track record and is superior to other anesthetic agents because it reliably preserves breathing reflexes.

The researchers note there have been no randomized clinical trials examining the effect of ketamine in chronic PTSD. The few that have been conducted were either retrospective or nonrandomized.

Building on previous research showing that ketamine is effective in treatment-resistant depression, the investigators conducted a proof-of-concept, randomized, double-blind, crossover trial comparing ketamine with an active placebo control, midazolam, another anesthetic agent that has pharmacokinetic parameters and nonspecific behavioral effects that are similar to ketamine.

“In recent years, we and others have shown that ketamine could often counter the symptoms of depression in treatment-resistant cases. In the present study, we hypothesized that ketamine would be associated with significantly greater reduction in core PTSD symptom levels 24 hours after a single IV infusion, and that it would also improve comorbid depressive symptoms in patients diagnosed with PTSD,” principal investigator Dennis Charney, MD, Anne and Joel Ehrenkranz Dean, Icahn School of Medicine at Mount Sinai, said in a statement.

The study included 41 patients between the ages of 18 and 55 years with a primary diagnosis of PTSD and a score of at least 50 on the Clinician-Administered PTSD Scale (CAPS). Study participants were free of concomitant psychotropic medications for 2 weeks prior to randomization and for the duration of the study.

The study’s primary outcome was change in PTSD symptom severity 24 hours after infusion, using the Impact of Event Scale–Revised (IES-R). Secondary outcome measures included the Montgomery- Åsberg Depression Rating Scale (MADRS), the Quick Inventor of Depressive Symptomatology, Self-Report (QIDS-SR), and the Clinical Global Impression–Severity (CGI-S) and –Improvement (CGI-I) scales administered at 24 hours, 48 hours, 72 hours, and 7 days after infusion.

In addition, adverse events were monitored with the Clinician-Administered Dissociative States Scale, the Brief Psychiatric Rating Scale, and the Young Mania Rating Scale.

Rapid Symptom Reduction

For each procedure day, patients were assigned to receive a single IV infusion of ketamine hydrochloride or midazolam administered during a period of 40 minutes.

The order of infusions was randomly assigned, and administrations occurred 2 weeks apart.

Ratings were administered at preinfusion baseline and 24 hours (day 1) after infusion (before patients were discharged from the hospital), 48 hours (day 2) after infusion, 72 hours (day 3) after infusion, and 7 days (day 7) after infusion.

Study results revealed that ketamine infusions were associated with a “significant and rapid reduction in PTSD symptom severity compared with midazolam 24 hours after infusion” (mean difference in IES-R score, 12.7; 95% confidence interval, 2.5 – 22.8; P = .02).

The investigators also report that there was a greater reduction of PTSD symptoms following treatment with ketamine in both crossover and first-period analyses that remained significant after adjusting for baseline and 24-hour depressive symptom severity.

The researchers also found that ketamine was associated with a reduction in comorbid depressive symptom severity and improvement in overall clinical presentation.

In addition, they report that the drug was “generally well tolerated without clinically significant persistent dissociative symptoms.”

“Our results provide the first evidence that a single dose of IV ketamine was associated with rapid reduction of core PTSD symptoms and reduction in comorbid depressive symptoms…,” the authors write.

They add that the results need to be replicated in other trials and that this research should “examine the efficacy and safety of ketamine beyond a single infusion for patients with chronic PTSD, explore the use of ketamine anesthesia to prevent the emergence of PTSD symptoms in surgical patients with a history of trauma, investigate the mechanisms of ketamine action, and identify pretreatment predictors of response to this intervention.”

This study was funded by the Department of the Army – US Navy Medical Research Acquisition Activity. Dr. Charney and Dr. Feder have been named as inventors on a patent application covering the use of ketamine for the treatment of PTSD.

A Randomized Trial of the Effects of Antibiotic Prophylaxis on Epidural-Related Fever in Labor

Sharma SK, Rogers BB, Alexander JM, McIntire DD, Leveno KJ

Anesth Analg. 2014;118:604-610

Study Summary

This is a double-blind study of 400 healthy nulliparous women requesting epidural analgesia at Parkland Hospital at the University of Texas Southwestern Medical Center. The participants were randomly assigned to receive either cefoxitin 2 g or placebo right before an epidural catheter was placed for labor analgesia (median duration, approximately 6 hours). This trial found that 38% of women administered cefoxitin developed fever, defined as a maternal temperature of greater than 38°C, which did not differ statistically from the 40% incidence of fever in the placebo group.

Neutrophilic infiltration of the placenta and membranes was found in approximately 50% of both study groups. Although fever developed significantly more often in women with placental neutrophilic inflammation than in those without this condition, no difference was detected in placental neutrophilic inflammation between the antibiotic group and the placebo group. The investigators also found no differences in any neonatal outcomes, and sepsis was not diagnosed in any infant. The conclusion of the study is that infection is unlikely to be the cause of fever during labor epidural analgesia.

Viewpoint

Many women having babies ask for, and receive, very effective pain relief with local anesthetics delivered through a catheter placed in the epidural space. It has been reported in many studies over the past 2 decades that these patients have a 2-4 times higher incidence of fever than similar patients not receiving epidural analgesia. It is worth mentioning that perhaps owing to the method of temperature assessment, the incidence of intrapartum fever of 38%-40% in the current study was a bit higher than the 10%-30% range in nulliparas receiving epidural analgesia reported in other studies.

The mechanism underlying epidural-related fever is unknown. It could be related to thermoregulatory effects of administering local anesthetic into the epidural space. However, this likely possibility has been ruled out by other studies, because vasodilation in the lower extremities from the sympathectomy of the epidural block would be expected to lower core body temperature, not raise it.

Another possible explanation for the association between epidural analgesia and fever is that intravenous opioids given in higher doses to laboring women who don’t receive epidural analgesia are somehow reducing maternal temperature, but there is little or no evidence to support that hypothesis.

Sharma and colleagues provide evidence that fever during labor epidural analgesia is associated with placental inflammation, but fever and placental inflammation were not reduced with antibiotic prophylaxis. The results of this randomized blinded study also go against another potential explanation — that epidural fever is a consequence of selection bias of epidural analgesia in women with dysfunctional prolonged labors who are at subsequent risk for infectious chorioamnionitis. As a result, the data presented in this study support a noninfectious inflammatory etiology as the most likely cause of epidural fever.

More research is required to elucidate how epidural analgesia might increase inflammation. Avoiding intrapartum fever matters, because it can result in neonatal sepsis evaluations and antibiotic treatment, and the parental anxiety that accompanies a sepsis evaluation if it is unneeded.

The higher you rise up the corporate ladder, the more often you tackle tough issues. High-impact issues are thorny and complex. They require deep focus to unravel their ambiguity. They require time.

But unfortunately, as the value of your strategic insight and expertise grows, so does the number of people who can lay legitimate claim to your time (board members, clients, cross-functional teams, and the growing number of people who report to you). Just as you develop the business acumen and wisdom necessary to understand big problems, you run out of the time necessary to actually solve them.

Studies show that executive “discretionary time” is rarely more than 5-10 hours per week. The rest of your time is preprogrammed — meetings, turning in things requested by others, people walking into your office with a crisis, etc.

This discretionary time crunch is nothing new. Peter Drucker noted the same dilemma nearly 60 years ago (so please forgive his male-centric language):

“Senior executives rarely have as much as one-quarter of their time truly at their disposal and available for the important matters, the matters that contribute, the matters they are being paid for. … If the executive lets the flow of events determine what he does, what he works on, and what he takes seriously, he will fritter himself away ‘operating.’”

If anything, the past 60 years have only made things worse. Researchers in the “Executive Time Use Project” found that executives were “ working alone … just six hours weekly” (out of 55). And recent McKinsey research shows that:

“…only 52 percent (of executives) said that the way they spent their time largely matched their organizations’ strategic priorities. Nearly half admitted that they were not concentrating sufficiently on guiding the strategic direction of the business.”

So when an urgent need for hiring comes along (like the departure of a senior-level employee), finding the extra time needed is deeply, profoundly inconvenient. And this lack of discretionary time is at the root of most hiring mistakes.

Faced with an inconvenient new priority and an already packed schedule, most managers do what they always do — they force-fit the problem solving into the wee slices of open time in their calendars. They quickly skim resumes, trying to glean more information than can reasonably be learned from a document like that. They severely limit the number of candidates they schedule for an interview. During the interviews, rather than delving into all the relevant issues, they skim the surface and then rely on “gut instinct” to make the hiring decision.

And while the “force-fit-it-into-my-calendar” approach might work for some internal business issues, it is disastrous in hiring. Hiring does not lend itself to a razor-thin time slicing approach because you’re not dealing with familiar people. They are generally not your subordinates or colleagues. Job candidates are complete strangers who have no relationship with you (yet). And since both interviewer and candidate lack the context to properly evaluate each other, each plays a game of “best foot forward” and relies far too heavily on unreliable first impressions. Candidates lack the context to truly understand your motivations. And when faced with ambiguity, most people simply nod and smile so as not to appear a fool.

The structure of the typical interview process often discourages frank conversation and rarely leaves time for enough intelligent questions. Hurried interviews are usually superficial, heavy on style, and light on substance. But once hired, work environments quickly demand precisely the substance that went overlooked during the interview. Misunderstandings and failures abound in hiring because when things go unsaid, there’s no shared context to properly fill in the gaps. The gaps are filled instead by dubious assumptions.

Seasoned executives would never give short shrift to a conversation with a new client or key external stakeholder. Instead they would rearrange other priorities and carve out the necessary time. Successful interviewing demands precisely the same approach.

Published in Eur Arch Otorhinolaryngol. 2014 Apr

Authors: Haksever M et al.,   

Abstract

The objective of this study is to compare the topical administration of bupivacaine hydrochloride, saline and bupivacaine hydrochloride infiltration on post-tonsillectomy pain in children. Sixty children undergoing tonsillectomy were enrolled in the study. Patients were randomized into three groups using sealed envelopes. Group 1 (n = 20) received topical 0.5 % bupivacaine hydrochloride, group 2 (n = 20) received topical 0.9 % NaCl (saline), and group 3 (n = 20) received 0.5 % bupivacaine hydrochloride infiltrated around each tonsil. 

Pain was evaluated using McGrath’s face scale. Pain scores in topical bupivacaine hydrochloride group was significantly lesser than the topical saline group at 5th, 13th, 17th and 21st hours, until the 6th day (p less than  0.017). 

Moreover, pain scores of topical bupivacaine hydrochloride group was superior to bupivacaine hydrochloride infiltration group at 5th, 13th, 17th hours and 2nd, 3rd, 4th and 5th day (p < 0.017). There were significantly lesser morbidities in topical bupivacaine hydrochloride than saline group in 1st and 4th day (p less than 0.017). 

Topical administration of bupivacaine hydrochloride proved to provide more efficient pain control than bupivacaine hydrochloride infiltration.

Published in Paediatr Anaesth. 2014 Mar

Authors: Coulter FL et al.,     

Abstract

BACKGROUND:

Propofol mixed with racemic ketamine (or ‘ketofol’) is popular for short procedural sedation and analgesia. Use is creeping into anesthesia, yet neither the optimal combination nor infusion rate is known. The EC50 of propofol’s antiemetic effect is reported to be 0.343 mg•l-1 , while ketamine analgesia is thought to persist with concentrations above 0.2 mg•l-1 . We aimed to determine a ketofol dosing regimen for anesthesia 30-min and 1.5-h duration in a healthy child that did not unduly compromise recovery.

METHODS:

Pharmacokinetic-pharmacodynamic parameters were used to simulate drug concentration and effect profiles over time for different ratios of propofol to ketamine ratios (1 : 1 to 10 : 1) and rates. The target effect was the 95% probability of loss of response to a 5-s transcutaneous tetanus (P05 ). Combined effects were additive, with a propofol EC50 of 3.1 mg•l-1 , ketamine EC50 of 0.64 mg•l-1 , and slope of 5.4. The time to predicted 50% probability of return of this response after ceasing infusion (P50 ) was determined for a 5-year-old 20-kg healthy child.

RESULTS:

The addition of ketamine to propofol infused using a manual infusion regimen (loading dose 3 mg•kg-1 , then 15 mg•kg-1 •h-1 for 15 min, 13 mg•kg-1 •h-1 for 15 min, 11 mg•kg-1 •h-1 for 30 min, and 10 mg•kg-1 •h-1 for 1-2 h) caused prolonged postoperative sedation. The P50 after a 1.5-h infusion using a 1 : 1 mixture was 4.5 h, 2 : 1 mixture was 3.25 h, 5 : 1 mixture was 1.6 h, and 10 : 1 mixture was 40 min. These P50 estimates could be reduced by slowing administration infusion rates to 20%, 33%, 50%, 67%, 80%, and 90% for mixtures 1 : 1, 2 : 1, 3 : 1, 5 : 1, 6.7 : 1, and 10 : 1, respectively. These rates achieve a P50 of approximately 20 min for 30-min duration anesthesia and 60 min for 1.5-h duration anesthesia.

CONCLUSIONS:

The addition of ketamine to propofol infusion will prolong recovery unless infusion rates are decreased. We suggest an optimal ratio of racemic ketamine to propofol of 1 : 5 for 30-min anesthesia and 1 : 6.7 for 90-min anesthesia. Delivery of these ratios achieves propofol concentrations above an antiemetic threshold for longer than the ketamine concentration above the analgesic threshold during, potentially reducing postoperative nausea incidence.

Published in Paediatr Anaesth. 2014 Mar 26

Authors:  Sun Y et al.,   

BACKGROUND:

In the current published literature, there are controversial results regarding the effectiveness of dexmedetomidine compared with midazolam as premedication in children. The aim of this meta-analysis was to compare the use of dexmedetomidine as a premedication in pediatric patients with that of midazolam.

METHODS:

We searched for articles published in English that matched the key words ‘dexmedetomidine’, ‘midazolam’, and ‘children’ in the PubMed, Cochrane Library, Ovid, and Google Scholar databases. Additional studies were identified from the reference lists of the retrieved articles. Only prospective randomized controlled trials (RCTs) that compared the use of dexmedetomidine and midazolam as premedications in children were included. The extraction of data from the articles was performed independently by two authors using a predesigned Excel spreadsheet. The relative risks (RRs), weighted mean differences (WMDs), and their corresponding 95% confidence intervals (95% CIs) were calculated for dichotomous and continuous outcome data using the quality effects model of the MetaXL version 1.3 software.

RESULTS:

Eleven prospective RCTs (829 children) met our criteria. Compared with midazolam, dexmedetomidine premedication was associated with more satisfactory sedation upon parent separation (eight RCTs [679 children]; RR: 1.25; 95% CI: 1.06, 1.46) and upon mask acceptance (seven RCTs [559 children]; RR: 1.17; 95% CI: 1.01, 1.36). During the postoperative period, premedication with dexmedetomidine lowered the numbers of requests for rescue analgesia (six RCTs [477 children]; RR: 0.55; 95% CI: 0.40, 0.74) and lowered the risks of agitation or delirium (seven RCTs with [466 children]; RR: 0.59; 95% CI: 0.40, 0.88), and shivering (three RCTs [192 children]; RR: 0.33; 95% CI: 0.18, 0.61). However, dexmedetomidine premedication reduced systolic blood pressure (three RCTs [242 children]; WMD: -11.47 mm•Hg-1 ; 95% CI: -13.95, -8.98), mean blood pressure (three RCTs [202 children]; WMD: -5.66 mm•Hg-1 ; 95% CI: -8.89, -2.43), and heart rate (six RCTs [444 children]; WMD: -12.71 beat•min-1 ; 95% CI: -14.80, -10.62), and prolonged the onset of sedation (two RCTs [132 children] WMD: 13.78 min; 95% CI: 11.33, 16.23; I2  = 0%) relative to midazolam.

CONCLUSION:

This meta-analysis demonstrated that dexmedetomidine premedication is superior to midazolam premedication in terms of producing satisfactory sedation upon parent separation and mask acceptance. Dexmedetomidine premedication provides clinical benefits that included reducing the requirements for rescue analgesia and reducing agitation or delirium and shivering during the postoperative period. However, the risks of heart rate and blood pressure decreases, and the prolonged onset of sedation associated with dexmedetomidine should be considered.

Published in Spine (Phila Pa 1976). 2014 Apr 11

Authors: Lisi AJ et al.,    

Abstract

Study Design. This work compared administrative data obtained from Department of Veterans Affairs (VA) databases with structured chart review.Objective. We set out to determine whether a decision tool using administrative data could be used to discriminate acute from non-acute cases among the many patients seen for a low back pain (LBP) related diagnosis.

Summary of Background Data. Large healthcare systems’ databases present an opportunity for conducting research and planning operations related to the management of highly burdensome conditions. An efficient method of identifying cases of acute LBP in these databases may be useful.

Methods. This was a retrospective review of all consecutive Iraq and/or Afghanistan Veterans seen in a VA primary care clinic during a six month period. Administrative data were extracted from VA databases. Patients with at least one encounter which was coded with at least one LBP-related ICD-9 code were included. Structured chart review of electronic medical record free text was the gold standard to determine acute LBP cases. Logistic regression models were used to assess the association of administrative data variables with chart review findings.

Results. We obtained complete data on 354 patient encounters, of which 83 (23.4%) were designated acute upon chart review. No diagnostic code was more likely to be used in acute cases than non-acute. We identified an administrative data model of 18 variables that were significant and positively associated with an acute case (C-statistic = 0.819). A reduced model of five variables including a lumbar MRI order, tramadol prescription, skeletal muscle relaxant prescription, physical therapy order, and addition of a new LBP-related ICD-9 code to the electronic medical record remained reasonable (C-statistic = 0.784).

Conclusions. Our results suggest that a decision model can identify acute from non-acute LBP cases in Veterans using readily available VA administrative data.

Published in Eur J Pain. 2014 Apr

Authors: Kamboj SK et al., 

BACKGROUND:

The effects of opioid medication on cognitive functioning in patients with cancer and non-cancer pain remain unclear.

METHOD:

In this mechanistic randomized, double-blind, placebo-controlled, cross-over study of patients (n = 20) receiving sustained-release and immediate-release opioid medication as part of their palliative care, we examine memory effects of an additional dose of participants’ immediate-release medication (oxycodone or morphine) or placebo. Immediate prose recall and recall of related and unrelated word pairs was assessed pre-and post-drug (placebo or immediate-release opioid). Memory for these stimuli was also tested after a delay on each testing occasion. Finally, performance on an ‘interference’ word pair task was assessed on the two testing occasions since proactive interference has been posited as a mechanism for acute opioid-induced memory impairment.

RESULT:

Unlike previous work, we found no evidence of memory impairment for material presented before or after individually tailored, ‘breakthrough’ doses of immediate-release opioid. Furthermore, immediate-release opioid did not result in increased memory interference. On the other hand, we found enhanced performance on the interference word pair task after immediate-release opioid, possibly indicating lower levels of interference.

CONCLUSION:

These results suggest that carefully titrated immediate-release doses of opioid drugs may not cause extensive memory impairment as previously reported, and in fact, may improve memory in certain circumstances. Importantly, our findings contrast strikingly with those of a study using the same robust design that showed significant memory impairment. We propose that factors, such as depressive symptoms, education level and sustained-release opioid levels may influence whether impairment is observed following immediate-release opioid treatment.

 

Published in Eur J Pain. 2014 Mar

Authors: Jensen TS et al.,     

BACKGROUND:

Application of the capsaicin 8% patch is associated with treatment-related discomfort. Consequently, pretreatment for 60 min with anaesthetic cream is recommended; however, this may be uncomfortable and time consuming.

METHODS:

We conducted a multicentre, randomized (1:1), assessor-blinded study in patients with peripheral neuropathic pain to assess tolerability of the capsaicin patch following topical lidocaine (4%) or oral tramadol (50 mg) pretreatment. The primary endpoint was the proportion of patients tolerating capsaicin patch application (ability to receive greater than 90% of a 60-min application). Numeric Pain Rating Scale (NPRS) scores were assessed before, during and after treatment.

RESULTS:

Overall, 122 patients were included (61 per arm). The capsaicin patch was tolerated by 121 patients. Tolerability of the capsaicin patch was similar following pretreatment with lidocaine and tramadol. Following patch application, pain levels increased up to 55 min (change from baseline of 1.3 for lidocaine and 1.4 for tramadol). After patch removal, tramadol-treated patients experienced greater pain relief up to the end of day 1; in the evening, mean changes in NPRS scores from baseline were 0 for lidocaine and -1 for tramadol. Proportions of patients reporting increases of greater than 2 NPRS points or greater than 33% from baseline at one or more time point(s) on the day of treatment were similar between arms. Adverse event incidence was comparable between arms.

CONCLUSIONS:

Capsaicin 8% patch tolerability was similar in the two arms, with comparable results for most secondary endpoints. Tramadol given 30 min before patch application should be considered as an alternative pretreatment option in patients receiving capsaicin patch treatment.