Lidocaine Patch (5%) in Treatment of Persistent Inguinal Postherniorrhaphy Pain

Background: Evidence-based pharmacological treatment options for patients with persistent inguinal postherniorrhaphy pain are lacking. Methods: Twenty-one male patients, with severe, unilateral, persistent inguinal postherniorrhaphy pain, participated in a randomized, double-blind, placebo-controlled crossover trial, receiving lidocaine patch (5%) and placebo patch treatments in periods of 14 days separated by a 14-day wash-out period. Pain intensities (at rest, during movement, and pressure evoked [Numerical Rating Scale]) were assessed before treatment and on the last 3 days of each treatment period. Patients were a priori divided into two subgroups based on quantitative sensory testing (+/− thermal “hyposensitivity”). Skin biopsies for intraepidermal nerve fiber density assessment were taken at baseline, and quantitative sensory testing was performed before and after each treatment period. The primary outcome was change in pain intensity assessed as the difference in summed pain intensity differences between lidocaine and placebo patch treatments. Results: There was no difference in summed pain intensity differences between lidocaine and placebo patch treatments in all patients (mean difference 6.2% [95% CI = −6.6 to 18.9%]; P = 0.33) or in the two subgroups (+/− thermal “hyposensitivity”). The quantitative sensory testing (n = 21) demonstrated an increased pressure pain thresholds after lidocaine compared with placebo patch treatment. Baseline intraepidermal nerve fiber density (n = 21) was lower on the pain side compared with the nonpain side (−3.8 fibers per millimeter [95% CI = −6.1 to −1.4]; P = 0.003). One patient developed mild erythema in the groin during both treatments. Conclusions: Lidocaine patch treatment did not reduce combined resting and dynamic pain ratings compared with placebo in patients with severe, persistent inguinal postherniorrhaphy pain.

Acute Dermal Irritation, Sensitization, and Acute Toxicity Studies of a Transdermal Patch for Prophylaxis Against (±) Anatoxin-A Poisoning

The skin irritating, sensitizing, and acute dermal toxicity potential of a novel combinational prophylactic transdermal patch, mainly composed of eserine and pralidoxime chloride as active pharmaceutical ingredients, against (±) anatoxin-a poisoning were investigated in rabbits, guinea pigs, and rats in compliance with the Organisation for Economic Cooperation and Development guidelines. In primary skin irritation test, rabbits were dermally attached with the therapeutically active transdermal patch or with a placebo patch for 72 hours. The transdermal patches did not induce any adverse reactions such as erythema and edema on intact skin sites. The active patch was classified as a practically nonirritating material based on the score in the primary irritation index. In the Buehler test, guinea pigs were sensitized by the active or placebo transdermal patches attached for 24 hours. The patches did not induce any sensitization reactions in contrast to a severe sensitization reaction that occurred in the positive control. Therefore, the active patch and placebo patch were both graded as weak in sensitization score and rate. Acute dermal toxicity test in rats did not produce any overt signs of toxicity following a 14-day treatment period. Taken together, these findings suggest that the transdermal patch does not cause skin irritation, skin sensitization, or dermal toxic effects following dermal application.

Traditional Chinese Herbal Patch for Short-Term Management of Knee Osteoarthritis: A Randomized, Double-Blind, Placebo-Controlled Trial

Objective. To assess the short-term efficacy and safety of two kinds of Traditional Chinese herbal patches, Fufang Nanxing Zhitong Gao (FNZG) and Shangshi Jietong Gao (SJG), for painful knee osteoarthritis (OA).Methods. Patients were randomly enrolled in a double-blind, placebo-controlled study to receive FNZG (n=60), SJG (n=60), or placebo patch (n=30) for 7 days. Outcome measures included visual analogue scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Traditional Chinese Medicine Syndrome Questionnaire (TCMSQ) subscale.Results. Although there was no significant difference among, three groups in short-term pain management, patients receiving FNZG got significant improvement in symptom of fear of coldness as compared with placebo patch (P=0.029). The most common local adverse events of rash, itching, erythema, and slightly damaged skin were observed in 7% of participants.Conclusions. FNZG may be a useful treatment for symptom of knee OA and merits long-term study in broader populations.

A Randomized Controlled Trial to Evaluate S-Caine Patch™ for Reducing Pain Associated with Vascular Access in Children

Background A randomized, double-blinded trial was performed to evaluate the efficacy and safety of the S-Caine Patch (ZARS, Inc., Salt Lake City, UT), a eutectic mixture of lidocaine and tetracaine, for pain relief during venipuncture in children. Methods With institutional review board approval, parental consent, and patient assent, 64 children who were scheduled for medically indicated vascular access at two centers were randomly assigned (2:1) to receive either an S-Caine Patch or a placebo patch for 20 min before venipuncture procedures. The primary outcome measure was the child's rating of pain during venipuncture using the Oucher pain scale. Additional measures of efficacy included the blinded investigator's and an independent observer's four-point categorical scores. Variables were compared between treatments using Mantel-Haenszel summary chi-square tests or Pearson chi-square tests. Results The S-Caine Patch produced significantly greater pain relief compared with placebo (median Oucher scores of 0 vs. 60; P < 0.001). Fifty-nine percent of the children in the S-Caine Patch group reported no pain compared with 20% of the children in the placebo patch group. The investigator estimated that 76% of the children in the S-Caine Patch group experienced no pain during venipuncture versus 20% in the placebo patch group (P = 0.001). Independent observer ratings also favored the S-Caine Patchtrade mark (P < 0.001). Mild skin erythema (< 38%) and edema (< 2%) occurred with similar frequencies between the groups. Conclusion This study demonstrated that a 20-min application of the S-Caine Patch is effective in lessening pain associated with venipuncture procedures. Adverse events after S-Caine Patch application were mild and transient.

Die topische Therapie stumpfer Weichteilverletzungen

Studien zeigen, dass topische NSA, wie das Diclofenac, leicht die Hautbarriere durchdringen und lokal eine therapeutische Wirksamkeit entfalten. Im Gegensatz zur oralen Gabe werden nach topischer Verabreichung um mehrere Grössenordnungen niedrigere Plasmaspiegel erreicht, womit das Fehlen systemischer Nebenwirkungen erklärt wird. Wir diskutieren die klinische Bedeutung von NSA-Patches am Beispiel einer randomisierten, Placebo-kontrollierten, doppelblinden Multizenterstudie, in der die Wirksamkeit und Verträglichkeit eines neu entwickelten Diclofenac-Patches bei der Therapie stumpfer Weichteilverletzungen untersucht wurde. Die Resultate zeigen, dass der Diclofenac-Patch signifikant wirksamer war als der Placebo-Patch (p < 0.0001) mit signifikant rascherer Beseitigung der Schmerzen. Die Verträglichkeit des Diclofenac-Patches war gut. Er sollte auch therapeutisch bei Indikationen mit vergleichbarem Pathomechanismus eingesetzt werden können.

Postoperative Pain Control with a New Transdermal Fentanyl Delivery System

Background A new transdermal delivery system for fentanyl is available in two strengths: 70-80 and 90-100 micrograms.kg-1.h-1 (40- and 60-cm2 patches, respectively). Their short onset and 24-h drug delivery make them attractive for postoperative pain control. Methods Both doses of the new transdermal fentanyl patches were evaluated for the relief of postoperative pain in 143 patients after gynecologic exploratory laparotomy. The study was conducted at four centers using a prospective, randomized, placebo-controlled, double-blind format. Patients were randomly assigned to one of three study groups: group 1 patients received two placebo patches: group 2 patients received a 40-cm2 fentanyl patch and a 60-cm2 placebo patch; and group 3 patients received a 60-cm2 fentanyl patch and a 40-cm2 placebo patch. Patient-controlled morphine use and pain, sedation, and comfort scores were assessed postoperatively every 4 h for 36 h after patch placement. Results Patients' assessment of their analgesia was significantly (P &lt; or = 0.05) better in group 2 at 16 and 24 h and in group 3 at 8, 12, 16, 20, and 24 h postoperatively, compared with the patients in group 1. Patients in groups 2 and 3 required less supplemental morphine to maintain satisfactory analgesia than did the patients in group 1. Patients in groups 2 and 3 had greater incidences of pruritus, erythema, and respiratory depression than did those receiving placebo. Conclusions Concern exists regarding the side effects of this this new transdermal fentanyl patch. Therefore, this new patch will need further research before it can be recommended as an adjunct in controlling postoperative pain.