• Title/Summary/Keyword: double blind

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Double blind randomized control trial to evaluate the efficacy of ketoprofen patch to attenuate pain during venous cannulation

  • Kumar, Sanjay;Sanjeev, Omprakash;Agarwal, Anil;Shamshery, Chetna;Gupta, Rakhi
    • The Korean Journal of Pain
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    • v.31 no.1
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    • pp.39-42
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    • 2018
  • Background: Venipuncture pain is an uncomfortable suffering to the patient. It creates anxiety, fear and dissatisfaction. The ketoprofen transdermal patch is a proven treatment for musculoskeletal and arthritic pain. We planned this study to evaluate the efficacy of the ketoprofen patch to reduce venipuncture pain. Methods: Two hundred adult patients, aged 18-60 years, of either sex, ASA grade I or II, were enrolled. Presuming that therapy would decrease venipuncture pain by 30%, a power calculation with ${\alpha}=0.05$ and ${\beta}=0.80$ required enrollment of at least 24 patients into each group. However, 100 patients in each group were recruited. Group I (Control) received a placebo patch; Group II (Ketoprofen) received a 20 mg ketoprofen patch. A selected vein on the dorsum of the patient's non-dominant hand was cannulated with 18 g intravenous cannula 1 h after the application of the respective patch. Assessment of pain was done by a 10 cm visual analogue scale (VAS) of 0-10, where 0 depicts "no pain" and 10 is "the worst imaginable pain". The venipuncture site was assessed for the presence of skin erythema, swelling and rashes at 12 h, 24 h and at the time of decannulation. Results: Incidence of pain was 100% (94/94) in the control group as compared to 93% (85/91) in the ketoprofen group. The severity of the venipuncture pain was 6 (2) and 2 (2) for control and ketoprofen groups respectively (P < 0.05). Conclusions: Application of a ketoprofen patch at the proposed site of venipuncture one hour before the attempt is effective and safe for attenuating venipuncture pain.

Transdermal Delivery and Analgesic Effects of Lidocaine Hydrogel by Phonophoresis (초음파를 이용한 리도카인 수용성겔의 경피흡수 및 진통효과)

  • Yang, Jae-Heon;Kim, Dae-Keun;Song, Kyung-Suk;Yun, Mi-Young;Ahn, Hyo-Cho;Kim, Young-Il;Kim, Tae-Youl
    • Journal of Pharmaceutical Investigation
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    • v.37 no.3
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    • pp.149-158
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    • 2007
  • To investigate the permeability of lidocaine, percutaneous absorption studies were performed using excised hairless mouse skin and the penetration of lidocaine via the skin was determined. To increase the skin permeation of lidocine, the effects of $Labrasol^{(R)}$, $Labrafil^{(R)}$, $Labrafac^{(R)}$ and $Transcutol^{(R)}$ were investigated. The skin permeation of lidocaine was increased when $Labrasol^{(R)}$ and $Transcutol^{(R)}$ were used as permeation enhancer. To evaluate the influence of ultrasound, various factors such as application modes (continuous mode and pulsed mode), frequency (1.0 and 3.0 MHz) and intensity (1.0, 1.5 and 2.0 w/$cm^2$) were investigated with lidocaine hydrogel. The pronounced effect of ultrasound on the skin permeation of lidocaine was observed at all ultrasound energy levels. The influence of frequency having an effect on skin permeation rate was higher in the case of using 1 MHz, 2.0 w/$cm^2$ and continuous treatment. As the intensity of ultrasound increased, the permeation of lidocaine was accelerated. The in vivo anesthetic effects were evaluated by two aspects as mechanical threshold and electrical threshold. Six healthy volunteers consented to the randomized, double-blind, and cross-over designed study in each group. In each subject, 3 groups were adapted such as K group (ultrasound with gel base only), L group (lidocaine gel) and B group (ultrasound with lidocaine gel). In conclusion, lidocaine was potent anesthetic which could be block pain threshold effectively. And ultrasound could accelerate the skin penetration of lidocaine. The phonophoretic delivery system could be a good candidate for lidocaine as a local anaesthetic to improve the skin permeation and in vivo anaesthetic effect.

The Efficacy of Preincisional Surgical Site Infiltration of Ketorolac & Bupivacain in Minimally Invasive Thyroid Surgery: A Double Blind Study (최소침습 갑상선절제술에서 피부절개전 Ketororac과 Bupivacaine 국소주사에 의한 진통효과)

  • Chung Woung-Youn;Kim Tae-Jin;Lee Hae-Kyung;Park Cheong-Soo
    • Korean Journal of Head & Neck Oncology
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    • v.16 no.2
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    • pp.182-186
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    • 2000
  • The reduction of the postoperative wound pain has been a concern in recent surgery, especially in various types of minimally-invasive surgeries. This study was performed to evaluate the postoperative analgesic effect of the preincisional local anesthesia with the mixture of ketorolac(Tarasyn) and bupivacaine to the surgical site in minimally-invasive thyroid surgeries. Of 491 patients who were scheduled for minimally-invasive thyroid surgeries between October 1999 and July 2000, 244 were randomly assigned to receive a mixture of ketorolac tromethamine 15mg(0.5ml) and 0.25% bupivacaine 3ml via surgical site infiltration 3 minutes prior to the skin incision. The outcomes of these patients were compared to those of the 247 controls. Total number of patients in need of post-operative analgesic requirements(n=39, 16.0%), total dose of postoperative analgesics used($19.6{\pm}8.4mg$ of ketorolac) and Visual Analogue Pain Score(VAS, $2.6{\pm}1.2$) of the preincisional local anesthesia group were significantly lower than those of the control group(p<0.05). The mean postoperative hospital stay was $1.6{\pm}0.4$ days for the preincisional local anesthesia group versus $1.9{\pm}0.7$ days for the control group. The preincisional local infiltration of ketorolac and bupivacaine in the minimally invasive thyroidectomies reduces postoperative wound pain thus would be more beneficial to the patients.

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Behavioral and Physiological Effects Induced by the Acute Administration of Melatonin in Healthy Young Men (정상인에서의 멜라토닌 투여에 따른 행동 및 생리적 효과)

  • Joe, Sook-Haeng;Nam, Min
    • Korean Journal of Psychosomatic Medicine
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    • v.5 no.2
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    • pp.195-204
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    • 1997
  • Objectives : The behavioral and physiological effects following low doses and high doses of melatonin have not been fully explored. In this study the authors investigated the nature and extent of the hypnotic effects, oral temperature, blood pressure effects, performance effects and subjective feelings following the acute administration of low pharmacological oral doses of melatonin at mid-day. Methods : Thirty-five healthy young medical students were randomly assigned to receive 6mg of oral melatonin(N=11), 12mg of oral melatonin(N=12) or a placebo(N=12) in a double-blind, placebo controlled trial. Measures of the behavioral and physiological effects used in the study were Stanford Sleepiness Scale, Digit Symbol Substitution Test, Trail test and visual analogue scale for subjective feelings. Oral temperature and blood pressure were measured. The subjects were studied between 10:00 and 16:00 hours. Data were analyzed by using repeated-measures analyses of variance(ANOVA). Results: Melatonin produced statistically significant effects on oral temperature, but there were no significant effects on time and the $dose{\times}time$ interaction. There was a significant difference on oral temperature between the 12mg oral melatonin group and the placebo group at 12:00 and 16:00 hours, but no significant difference between the 12mg and the 6mg oral melatonin groups. Melatonin produced a dose-related increase in subjective sleepiness and had significant effects on time, the $dose{\times}time$ interaction. There was a significant difference on subjective sleepiness among the placebo, 6mg, 12mg oral melatonin groups at 13:00-16:00 hours. Melatonin did not produce statistically significant dose-related effects on subjective fatigue but produced significant effects on time and the $dose{\times}time$ interaction. There was a significant difference on subjective fatigue between the 12mg, the 6mg oral melatonin groups and the placebo group at 13:00 hour. Conclusions : These data indicated that acute administration of melatonin at mid-day increased subjective sleepiness and fatigue but decreased oral temperatures. These effects were shown especially in 12mg oral melatonin group.

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Effect of Preoperative Analgesia with Epidural Morphine in Upper Abdominal Surgery (상복부 수술 환자에서 경막외 Morphine의 술전 투여와 술중 투여시 진통 효과 비교)

  • Kim, Yun-Hee;Yoo, Rae-Ho;Ko, Seong-Hoon;Han, Young-Jin;Choe, Huhn
    • The Korean Journal of Pain
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    • v.11 no.1
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    • pp.41-46
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    • 1998
  • Background: Preoperative analgesia may prevent nociceptive inputs generated during surgery from sensitizing central neurons and therefore may preempt postoperative pain. Although preemptive analgesia has shown to decrease postinjury pain in animals, studies in human are not consistent. We studied whether epidural morphine injection before surgical incision could affect postoperative pain and analgesic demands, compared with injection after removal of specimen. Methods: Forty patients scheduled for radical subtotal gastrectomy were randomly assigned to one of two groups for prospective study in a double-blind manner. Group 1 received an epidural injection of 3 mg of morphine in 8 ml of 0.9% saline before surgical incision, and Group 2 after removal of specimen. Postoperative pain relief was provided with I.V. patient controlled analgesia (PCA) system. Numerical rating scales for pain and mood, Prince Henry Hospital scores for pain, cumulative PCA analgesic consumptions, and incidence of side effects were assessed at 2, 6, 12, 24, 48 hours after operation. Results: Cumulative PCA analgesic consumption in group 1 was significantly less than in group 2 at 2, 6 hours after surgery. Pain scores and the incidence of side effects were similar in both groups. Conclusions: Preoperative analgesia with epidural morphine showed little difference in patient controlled analgesic consumption after upper abdominal surgery compaired to intraoperative morphine.

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Continuous Epidural Infusion of Bupivacaine with Tramadol for Post-Cesarean Analgesia (제왕절개술후 통증치료시 지속적 경막외 국소마취제와 Tramadol의 병용투여의 효과)

  • Kang, Po-Soon;Cho, Jae-Kun
    • The Korean Journal of Pain
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    • v.11 no.1
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    • pp.54-59
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    • 1998
  • Background: Tramadol administered epidurally is known to have one-thirtieth the potency of morphine for treatment of pain following abdominal surgery. We designed a prospective, randomized, controlled study to evaluate the analgesic efficacy and safety of combined epidural infusion of bupivacaine and tramadol with 2-day infusor as ompared to bupivacaine and morphine combined epidural infusion. Methods: Sixty healthy women scheduled for Cesarean delivery were assigned randomly in double- blind fashion: Group 1 (n=20) were given a mixture of morphine 10 mg(1 ml), 0.5% bupivacaine 40 ml and normal saline(NS) 40 ml; Group 2(n=20) a mixture of tramadol 300 mg(6 ml), 0.5% bupivacaine 40 ml and NS 54 ml; Group 3(n=20) or a mixture of tramadol 500 mg(10 ml), 0.5% bupivacaine 50 ml and NS 50 ml, of continuous dose via epidural route following 1% lidocaine 6 ml as bolus dose for 48 hours postoperatively. We evaluated the analgesic efficacy and side effects of these three groups using visual analogue pain scale (VAPS) and verbal rating scale (VRS). Results: VAPS of group 1 and 3 were lower than group 2, and VAPS of group 1 was lower than group 3(12, 24, 36, 48 hours). VRS of group 1 and 3 were lower than group 2 (12, 24, 36 hours). There were incidences of pruritus was 16 patients in group 1. Conclusions: Tramadol does possess the analgesia effect of morphine, but has the added analgesia following increment. Further research to determine the most effective administration method and reguired dosage of tramadol is further needed.

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Pain alleviation in patients undergoing cardiac surgery; presternal local anesthetic and magnesium infiltration versus conventional intravenous analgesia: a randomized double-blind study

  • Kamel, Emad Zarief;Abd-Elshafy, Sayed Kaoud;Sayed, Jehan Ahmed;Mostafa, Mohammed Mahmoud;Seddik, Mohamed Ismail
    • The Korean Journal of Pain
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    • v.31 no.2
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    • pp.93-101
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    • 2018
  • Background: Magnesium is one of the effective, safe local anesthetic adjuvants that can exert an analgesic effect in conditions presenting acute and chronic post-sternotomy pain. We studied the efficacy of continuous infusion of presternal magnesium sulfate with bupivacaine for pain relief following cardiac surgery. Methods: Ninety adult patients undergoing valve replacement cardiac surgery randomly allocated into three groups. In all patients; a presternal catheter was placed for continuous infusion of either 0.125% bupivacaine and 5% magnesium sulfate (3 ml/h for 48 hours) in group 1, or 0.125% bupivacaine only in the same rate in group 2, versus conventional intravenous paracetamol and ketorolac in group 3. Rescue analgesia was iv $25{\mu}g$ fentanyl. Postoperative Visual Analog Scale (VAS) and fentanyl consumption during the early two postoperative days were assessed. All patients were followed up over two months for occurrence of chronic post-sternotomy pain. Results: VAS values showed high significant differences during the first 48 hours with the least pain scale in group 1 and significantly least fentanyl consumption ($30.8{\pm}7{\mu}g$ in group 1 vs. $69{\pm}18{\mu}g$ in group 2, and $162{\pm}3$ in group 3 respectively). The incidence of chronic pain has not differed between the three groups although it was more pronounced in group 3. Conclusions: Continuous presternal bupivacaine and magnesium infusion resulted in better postoperative analgesia than both presternal bupivacaine alone or conventional analgesic groups.

The influence of obesity on the effects of spirulina supplementation in the human metabolic response of Korean elderly

  • Park, Hee-Jung;Lee, Hyun-Sook
    • Nutrition Research and Practice
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    • v.10 no.4
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    • pp.418-423
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    • 2016
  • BACKGROUND/OBJECTIVES: Spirulina, a blue-green alga, is widely produced and commercialized as a dietary supplement with bio- and immune-modulatory functions. We have previously shown that spirulina had favorable effects on lipid profiles, immune functions, and antioxidant capacity in healthy Korean elderly. Despite favorable effect of spirulina supplementation, some sub-populations have shown a poor response to supplementation. Obesity is a factor related to poor-response. Therefore, the purpose of this study was to determine the immuno-modulation, antioxidant capacity, and lipid-lowering effect of spirulina in obese and non-obese Korean elderly. SUBJECTS/METHODS: The subjects were 78 elderly aged 60-87 years. In a randomized double blind, placebo-controlled study, subjects were fed either placebo or spirulina daily, at 8 g for 12 weeks. Subjects were divided into the non-obese group and the obese group based on body mass index (BMI) criteria for Asians suggested by the International Obesity Task Force: $BMI<25kg/m^2$ (non-obese) and $BMI{\geq}25kg/m^2$ (obese). RESULTS: In the non-obese group, spirulina supplementation showed a significant lowering effect on plasma concentration of total cholesterol and LDL-cholesterol, a significant increase in interleukin (IL)-2 concentration (P < 0.01) and a significant increment (P < 0.05) in IL-2/IL-6 ratio, and a significant increase in total antioxidant status level and a significant decrease in thiobarbituric acid reactive substances level. However, these effects were not observed in the obese group. CONCLUSION: These results demonstrated that blood lipid lowering and immune and antioxidant improving response for spirulina supplement was affected by obesity in Korean elderly.

Preemptive Use of Ketamine on Post Operative Pain of Appendectomy

  • Behdad, Akbar;Hosseinpour, Mehrdad;Khorasani, Parastoo
    • The Korean Journal of Pain
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    • v.24 no.3
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    • pp.137-140
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    • 2011
  • Background: Although early reviews of clinical findings were mostly negative, there is still a widespread belief for the efficacy of preemptive analgesia among clinicians. In this study, we evaluated whether the preemptive use of ketamine decreases post operative pain in patients undergoing appendectomy. Methods: In double-blind, randomized clinical trials, 80 adult male patients undergoing an operation for acute appendicitis were studied. Patients were randomly assigned to two groups. In the operating room, patients in the ketamine group received 0.5 mg/kg of ketamine IV 10 minutes before the surgical incision. In the control group, 0.5 mg/kg of normal saline was injected. The pain intensity was assessed at time 0 (immediately after arousal) and 4, 12, and 24 hours postoperatively using the 10 points visual analogue scale (VAS). Results: Eighty patients (40 for both groups) were enrolled in this study. For all of the evaluated times, the VAS score was significantly lower in the ketamine group compared to the control. The interval time for the first analgesic request was $23.1{\pm}6.7$ minutes for the case group and $18.1{\pm}7.3$ minutes for the control (P = 0.02). The total number of pethidine injections in the first 24 hours postoperatively was $0.6{\pm}0.6$ for the case group and $2.0{\pm}0.8$ for the controls (P = 0.032). There were no drug side effects for the case group. Conclusions: A low dose of intravenously administered ketamine had a preemptive effect in reducing pain after appendectomy.

The impact of magnesium sulfate as adjuvant to intrathecal bupivacaine on intra-operative surgeon satisfaction and postoperative analgesia during laparoscopic gynecological surgery: randomized clinical study

  • Mohamed, Khaled Salah;Abd-Elshafy, Sayed Kaoud;El Saman, Ali Mahmoud
    • The Korean Journal of Pain
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    • v.30 no.3
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    • pp.207-213
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    • 2017
  • Background: Surgeon satisfaction and patient analgesia during the procedure of laparoscopic surgery are important issues. The aim of this work was to study if an intrathecal (IT) Bupivacaine combined with Magnesium sulfate may or may not provide good surgeon satisfaction in addition to improvement of intraoperative and postoperative analgesia. Methods: Sixty female patients were enrolled in this prospective, randomized, double-blind controlled clinical trial study. All patients were operated for gynecological laparoscopic surgery under spinal anesthesia. Patients were divided into two groups (Bupivacaine and Magnesium). Group Bupivacaine (30 patients) received intrathecal Bupivacaine 0.5% only (15 mg), while 30 patients in group Magnesium received intrathecal Bupivacaine (15 mg) in addition to intrathecal Magnesium sulfate (50 mg). The sensory block level, the intensity of motor block, the surgeon satisfaction, the intraoperative visual analog scale (VAS) for pain assessment, the postoperative VAS, and side effects were recorded during the intraoperative period and within the first 24 hours after surgery in the post-anesthesia care unit. Results: Surgeon satisfaction, intraoperative shoulder pain, postoperative pain after 2 h, and perioperative analgesic consumption (ketorolac) were significant better in group Magnesium than in group Bupivacaine. (P < 0.05). The onset of motor and sensory blocks was significant longer in group Magnesium than the other one. The incidence of PONV, pruritus and urinary retention was insignificant statistically between both groups. Conclusions: Magnesium sulfate if used intrathecally as an adjuvant to Bupivacaine would provide a better surgeon satisfaction and would improve the analgesic effect of spinal anesthesia used for gynecological laparoscopic surgery.