Capsaicin 8% Patch Repeat Treatment in Nondiabetic Peripheral Neuropathic Pain: A 52-Week, Open-Label, Single-Arm, Safety Study.

OBJECTIVES: To investigate the long-term safety and tolerability of capsaicin 8% patch repeat treatment in nondiabetic patients with peripheral neuropathic pain. METHODS: A prospective, open-label, observational study in patients with postherpetic neuralgia, posttraumatic or postsurgical nerve injury, HIV-associated distal sensory polyneuropathy, or other peripheral neuropathic pain, and average daily pain score ≥4, who received ≤6 capsaicin 8% patch treatments over 52 weeks according to clinical need (retreatment at 9 to 12 wk intervals). Sensory testing and analgesic effectiveness were assessed using "bedside tests" and Brief Pain Inventory (question 5). RESULTS: Overall, 306 patients received treatment. Treatment-emergent adverse events (TEAEs) and drug-related TEAEs were reported by 252 (82.4%) and 207 (67.6%) patients. Application site pain was the most common drug-related TEAE (n=112, 36.6%); no drug-related serious TEAEs were reported. Sensory category shift analyses from baseline to end of study (EoS) in patients attending at least 2 sensory visits (n=278 for all tests except warm, n=277) found sensory deterioration/loss in at least 1 modality in 50.4% (n=140); deterioration/loss in 1, 2, 3, 4, or 5 modalities occurred in 26.6% (n=74), 14.0% (n=39), 5.8% (n=16), 2.5% (n=7), and 1.4% (n=4) cases. Newly emergent hyperesthesia or allodynia was apparent in 1.1% to 3.6% of the cases (depending on modality) by EoS. Between 25.2% and 32.0% of patients reported improvement in a sensory modality by EoS. Average daily pain was 6.6 and 4.7 at baseline and month 12. CONCLUSIONS: Generally, capsaicin 8% patch repeat treatment over 52 weeks was well tolerated, with variable alteration in sensory function and minimal chance of complete sensory loss.

5% Lidocaine Medicated Plaster for the Treatment of Postherpetic Neuralgia: A Review of the Clinical Safety and Tolerability.

Postherpetic neuralgia (PHN) is a common, very painful, and often long-lasting complication of herpes zoster which is frequently underdiagnosed and undertreated. It mainly affects the elderly, many of whom are already treated for comorbidities with a variety of systemic medications and are thus at high risk of drug-drug interactions. An efficacious and safe treatment with a low interaction potential is therefore of high importance. This review focuses on the safety and tolerability of the 5% lidocaine medicated plaster, a topical analgesic indicated for the treatment of PHN. The available literature (up to June 2014) was searched for publications containing safety data regarding the use of the 5% lidocaine medicated plaster in PHN treatment; unpublished clinical safety data were also included in this review. The 5% lidocaine medicated plaster demonstrated good short- and long-term tolerability with low systemic uptake (3 ± 2%) and minimal risk for systemic adverse drug reactions (ADRs). ADRs related to topical lidocaine treatment were mainly application site reactions of mild to moderate intensity. The treatment discontinuation rate was generally below 5% of patients. In one trial, the 5% lidocaine medicated plaster was better tolerated than systemic treatment with pregabalin. The 5% lidocaine medicated plaster provides a safe alternative to systemic medications for PHN treatment, including long-term pain treatment.

Analgesic efficacy of orodispersible paracetamol in patients admitted to the emergency department with an osteoarticular injury.

INTRODUCTION: Acute pain still persists in patients under treatment after admission to emergency departments (ED). The objective of this study was to determine the efficacy of 1 g of paracetamol in patients presenting an osteoarticular injury. MATERIALS AND METHODS: This prospective study included all patients admitted to the ED with an osteoarticular injury and a pain score above 30 on the visual analogue scale (VAS). Patients were selected on admission by the reception nurse and given paracetamol within 5 min of admission. VAS scores were recorded 30 and 60 min after admission. On discharge from the ED, the patients underwent a further VAS assessment and were asked a question about pain relief (yes/no answer). The primary endpoint was the VAS score at 60 min. The secondary endpoint was the pain relief expressed by the patient on discharge from the ED. RESULTS: Five hundred and seventy-one patients were included. The median stay in the ED was 90 min (75-120 min). The diagnoses at discharge were sprain or dislocation (ankle, knee, and wrist) for 287 patients, fracture for 102 patients, and other injury for 182 patients. In 69% of the patients, the injured limb was immobilized. The median VAS score on admission was 57. A significant difference was seen between the median VAS on admission and at 1 h after admission (57+/-18 vs. 30+/-18; P<0.0001), and between the median VAS score at admission and the score at discharge from the ED (57+/-18 vs. 26+/-18, P<0.0001). Finally, 81% of the patients expressed pain relief. On discharge from the ED, a gain of 20 mm on the VAS had a positive predictive value of 93% [area under curve (AUC): 89; CI: 86-92; P=0.001], for the endpoint 'patients stating pain relief'. CONCLUSION: A simple and easily applicable protocol of pain management permits the achievement of satisfactory analgesia during a patient's stay in the ED.

Towards a new taxonomy of idiopathic orofacial pain.

There is no current consensus on the taxonomy of the different forms of idiopathic orofacial pain (stomatodynia, atypical odontalgia, atypical facial pain, facial arthromyalgia), which are sometimes considered as separate entities and sometimes grouped together. In the present prospective multicentric study, we used a systematic approach to help to place these different painful syndromes in the general classification of chronic facial pain. This multicenter study was carried out on 245 consecutive patients presenting with chronic facial pain (>4 months duration). Each patient was seen by two experts who proposed a diagnosis, administered a 111-item questionnaire and filled out a standardized 68-item examination form. Statistical processing included univariate analysis and several forms of multidimensional analysis. Migraines (n=37), tension-type headache (n=26), post-traumatic neuralgia (n=20) and trigeminal neuralgia (n=13) tended to cluster independently. When signs and symptoms describing topographic features were not included in the list of variables, the idiopathic orofacial pain patients tended to cluster in a single group. Inside this large cluster, only stomatodynia (n=42) emerged as a distinct homogenous subgroup. In contrast, facial arthromyalgia (n=46) and an entity formed with atypical facial pain (n=25) and atypical odontalgia (n=13) could only be individualised by variables reflecting topographical characteristics. These data provide grounds for an evidence-based classification of idiopathic facial pain entities and indicate that the current sub-classification of these syndromes relies primarily on the topography of the symptoms.

Topical clonazepam in stomatodynia: a randomised placebo-controlled study.

Stomatodynia is characterised by a spontaneous burning pain in the oral mucosa without known cause or recognised treatment. The purpose of this double-blind, randomised, multicentre parallel group study was to evaluate the efficacy of the topical use of clonazepam. Forty-eight patients (4 men and 44 women, aged 65+/-2.1 years) were included, of whom 41 completed the study. The patients were instructed to suck a tablet of 1 mg of either clonazepam or placebo and hold their saliva near the pain sites in the mouth without swallowing for 3 min and then to spit. This protocol was repeated three times a day for 14 days. The intensity was evaluated by a 11-point numerical scale before the first administration and then after 14 days. Two weeks after the beginning of treatment, the decrease in pain scores was 2.4+/-0.6 and 0.6+/-0.4 in the clonazepam and placebo group, respectively (P = 0.014). Similar effects were obtained in an intent-to-treat analysis (P = 0.027). The blood concentration of clonazepam was similar whether it was measured 14 days after sucking a tablet three times a day or during the 5 h that followed sucking a single tablet (n = 5). It is hypothesised that clonazepam acts locally to disrupt the mechanism(s) underlying stomatodynia.

[Standards, options and recommendations for the use of medical analgesics for the treatment of pain arising from excess nociception in adults with cancer (update 2002): opioid analgesics with the exception of morphine by mouth and the rotation]. / Standards, Options et Recommandations 2002 pour les traitements antalgiques médicamenteux des douleurs cancéreuses par excès de nociception chez l'adulte, mise à jour : place des opioïdes forts (morphine orale exclue) et rotation des opioïdes.

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the federation of French Cancer Centers (FNCLCC), the 20 French cancer centers, and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines for the use of opioid analgesics with the exception of oral morphine and for opioid rotation related to the treatment of nociceptive pain in adults with cancer according to the definitions of the Standards, Options and Recommendations project. METHODS: In 1996, a working group, set up by the FNCLCC published clinical practice guidelines for pain management in adult and paediatric patients with cancer: In the light of the evolution of knowledge, and practice these guidelines need to be updated The section on "médical analgesic treatments" in the document published in 1996 was examined by the working group to identify which questions should be updated. These questions and the relevant key words were used to develop a search strategy which was used to search Medline, and for particular questions, Embase, from January 1994 to March 1999, for relevant references, published in English or French. RESULTS: For this update, only a few randomised clinical trials were identified, and their conclusions were generally weak. Thus much of the information in this document is based on the World Health Organisation (WHO) guidelines and represents the "state of the art" on this subject in France and is supported by expert agreement. Some changes to the original SOR are presented, particularly for the prescription of new opioids and opioid rotation. The full text of this SOR is available on the FNCLCC web site (http ://www.fnclcc.fr).

[Standards, options and recommendations for the use of medical analgesics for the treatment of pain arising from excess nociception in adults with cancer (update 2002)]. / Standards, Options et Recommandations 2002 pour les traitements antalgiques médicamenteux des douleurs cancéreuses par excès de nociception chez l'adulte, mise à jour (rapport abrégé).

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of french cancer centers (FNCLCC), the 20 French cancer centers, and specialists from French public universities, general hospitals and private clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and the outcome of cancer patients. The methodology is based on a literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop clinical practice guidelines for the use of medical analgesics for the treatment of pain arising from excess nociception in adults with cancer according to the definitions of the Standards, Options and Recommendations project. METHODS: In 1996, a working group, set up by the FNCLCC published clinical practice guidelines for pain management in adult and paediatric patients with cancer. In the light of the evolution of our knowledge, and practice these guidelines need to be updated. The section on "medical analgesic treatments" in the document published in 1996 was examined by the working group to identify which questions should be updated. These questions and the relevant key words were used to develop a search strategy which was used to search Medline , and for particular questions, Embase , from January 1994 to March 1999, for relevant references, published in English or French. RESULTS: For this update, only a few randomised clinical trials were identified, and their conclusions were generally weak. Thus much of the information in this document is based on the World Health Organisation (WHO) guidelines and represents the "state of the art" on this subject in France and is supported by expert agreement. Some changes to the original SOR are presented, eg. methods of titration, prescription of new opioids, opioid rotation. We also present a synthesis of recent pharmacological and regulatory data. The integral version is available on the FNCLCC web site (http://www.fnclcc.fr/sor.htm).