scholarly journals Analgesic efficacy of nefopam for cancer pain: a randomized controlled study

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 378
Author(s):  
Koravee Pasutharnchat ◽  
Wichita Wichachai ◽  
Rungrawan Buachai
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Cancer Pain ◽  
Breakthrough Pain ◽  
Analgesic Efficacy ◽  
Pain Reduction ◽  
Morphine Consumption ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Significant Pain

Background: Nefopam is a non-opioid, non-steroidal, central acting drug used effectively for postoperative pain. The efficacy of nefopam for cancer pain remains unclear. We aimed to evaluate the analgesic efficacy of nefopam for cancer pain in a randomized controlled trial. Methods: Patients with moderate to severe cancer pain (n=40) were randomly divided into two groups. The nefopam group (n=20) received three 20 mg doses of nefopam every 8 hours. The placebo group (n=20) received normal saline. Intravenous patient-controlled analgesia with morphine was given for breakthrough pain for 48 hours. The primary outcome was significant pain reduction. Secondary outcomes were morphine consumption over 48 hours and incidence of side effects. Results: The nefopam group showed pain reduction at 12 hours (65% of patients), 24 hours (80%), 36 hours (85%), and 48 hours (65%). The placebo group showed pain reduction at 12 hours (70%), 24 hours (75%), 36 hours (80%), and 48 hours (60%). However, there were no statistically significant differences between the groups (p>0.05). The median dosage of morphine consumption in 48 hours was lower in the nefopam group (25.5 mg) compared with the placebo group (37 mg), but this was not statistically significant (p=0.499). There were no statistically significant differences in blood pressure and heart rate between the groups. Side effects in both groups were comparable. Conclusions: At dosage of 60 mg in 24 hours, nefopam did not provide significant pain reduction in moderate to severe cancer pain patients. However, there was a trend of reduced opioid consumption. Further studies with larger sample sizes, longer duration, or higher doses of nefopam are warranted. Registration: Thai Clinical Trail Registry (TCTR) ID TCTR20181016001; registered on 12 October 2018.

The Effects of 6-Week Supplementation with Multicomponent Herbal Extract on Exercise Performance, Antioxidant Status and Telomere Length, and Self-Reported Side Effects in Healthy Men: A Randomized Controlled Pilot Trial

2020 ◽  
Vol 19 (4) ◽  
pp. 520-524
Author(s):  
Valdemar Stajer ◽  
Nikola Todorovic ◽  
Darinka Korovljev ◽  
Nebojsa Maksimovic ◽  
Suzana Miljkovic ◽  
...  
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Antioxidant Capacity ◽  
Telomere Length ◽  
Exercise Performance ◽  
Antioxidant Status ◽  
Herbal Extract ◽  
Healthy Men ◽  
Randomized Controlled

The main aim of this study was to examine the effects of medium-term supplementation with an eight-herbs extract on running performance, biomarkers of antioxidant status and telomere length, and self-reported outcome measures of safety events in healthy men. Ten healthy young men (age 23.1±3.2 years, weight 73.7±9.9kg, and height 179.4±8.0cm) volunteered to participate in this randomized controlled trial. The participants were allocated in a double-blind cross-over design to receive either an eight-herbs extract or placebo during a 6-week intervention period. Two-way mixed analysis of variance (treatment vs. time interaction) revealed no significant differences for exercise performance outcomes and telomere length between groups (P>0.05). Compared with placebo, P-DNA provoked a significant rise in serum total antioxidant capacity (316.0±183.4µmol/mL at baseline; 792.7±68.1µmol/mL at follow-up in the eight-herbs extract group vs. 298.1±90.7µmol/mL at follow-up in the placebo group; P<0.001), and less reduction in serum superoxide dismutase levels at follow-up (150.4±5.1IU/mL at baseline; 145.5±3.0IU/mL at follow-up in the eight-herbs extract group vs. 139.3±3.3IU/mL at follow-up in the placebo group; P=0.01). No participant reported any side effects of either intervention. The eight-herbs extract can thus be recommended as a well tolerated dietary supplement that can enhance antioxidant capacity in healthy men. This trial was registered at ClinicalTrials.gov (NCT04263246).

Postoperative analgesia by adding acupuncture to conventional therapy, a non-randomized controlled trial

2018 ◽  
Vol 16 (2) ◽  
Author(s):  
Ilana Levy ◽  
Samuel Attias ◽  
Lior Cohen ◽  
Nadav Stoppelmann ◽  
Dan Steinberger ◽  
...  
Keyword(s):  
Side Effects ◽  
Postoperative Pain ◽  
Analgesic Effect ◽  
Pain Treatment ◽  
Standard Of Care ◽  
Acupuncture Group ◽  
Controlled Study ◽  
Control Group ◽  
Pain Level ◽  
Randomized Controlled

Abstract Background Postoperative pain is common in patients hospitalized in surgical departments, yet it is currently not sufficiently controlled by analgesics. Acupuncture, a complementary medical practice, has been evaluated for its benefits in postoperative pain with heterogeneous results. We tested the feasibility of a controlled study comparing the postoperative analgesic effect of acupuncture together with standard-of-care to standard-of-care only. Methods In this pilot non-randomized controlled study conducted at a tertiary medical center in Israel, patients received either acupuncture with standard-of-care pain treatment (acupuncture group) or standard-of-care treatment only (control group) following surgery. Visual Analogue Scale (VAS) ratings for pain level at rest and in motion were evaluated both at recruitment and two hours after treatment. Acupuncture-related side effects were reported as well. Results We recruited 425 patients; 336 were assigned to the acupuncture group and 89 to the control group. The acupuncture group exhibited a decrease of at least 40% in average level of pain both at rest (1.8±2.4, p<0.0001) and in motion (2.1±2.8, p<0.0001) following acupuncture, whereas the control group exhibited no significant decrease (p=0.92 at rest, p=0.98 in motion). Acupuncture's analgesic effect was even more prominent in reducing moderate to severe pain at baseline (VAS ≥4), with a decrease of 49% and 45% of pain level at rest and in motion respectively (p<0.001), compared with no significant amelioration in the control group (p=0.20 at rest, p=0.12 in motion). No major side effects were reported. Conclusion Integrating acupuncture with standard care may improve pain control in the postoperative setting.

scholarly journals Prospective Randomized Controlled Study to assess the Role of Dexmedetomidine on Perioperative Hemodynamics in Patients with Supratentorial Tumor undergoing Surgery

2017 ◽  
Vol 2 (1) ◽  
pp. 14-17
Author(s):  
Sachin Vaishnav ◽  
Anita Shetty ◽  
Manjula Sarkar
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Arterial Blood Pressure ◽  
Randomized Controlled Study ◽  
Controlled Study ◽  
Randomized Controlled ◽  
Arterial Blood ◽  
Supratentorial Tumor ◽  
Duration Of Surgery

ABSTRACT The stress response to an intense painful surgical stimulus is characterized by activation of the sympathetic nervous system and an increased secretion of the stress hormones. The ability of the alpha agonist dexmedetomidine (DEX) to decrease heart rate (HR) and arterial blood pressure in perioperative period was tested. One hundred and thirty two patients undergoing craniotomy for supratentorial tumor were randomly distributed to receive either saline (B group) or DEX (A group). The placebo group received saline, whereas the treatment group (A group) received a single bolus dose of DEX (1μg/kg) intravenously over 10 minutes before induction of anesthesia. Hemodynamic parameters, such as HR and arterial blood pressure were measured. Both the groups were comparable with respect to age, sex, American Society for Anesthesiologist grade, and duration of surgery. The arterial blood pressure and HR were found to be lower in the DEX group when compared with the placebo group. How to cite this article Vaishnav S, Shetty A, Sarkar M. Prospective Randomized Controlled Study to assess the Role of Dexmedetomidine on Perioperative Hemodynamics in Patients with Supratentorial Tumor undergoing Surgery. Res Inno in Anesth 2017;2(1):14-17.

Implementing Guidelines for Cancer Pain Management: Results of a Randomized Controlled Clinical Trial

1999 ◽  
Vol 17 (1) ◽  
pp. 361-361 ◽  
Author(s):  
Stuart L. Du Pen ◽  
Anna R. Du Pen ◽  
Nayak Polissar ◽  
Jennifer Hansberry ◽  
Beth Miller Kraybill ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Decision Making ◽  
Pain Management ◽  
Cancer Pain ◽  
Symptom Management ◽  
Controlled Study ◽  
Cancer Pain Management ◽  
Randomized Controlled ◽  
Prospective Longitudinal

PURPOSE: Pain and symptom management is an integral part of the clinical practice of oncology. A number of guidelines have been developed to assist the clinician in optimizing comfort care. We implemented clinical guidelines for cancer pain management in the community setting and evaluated whether these guidelines improved care. PATIENTS AND METHODS: Eighty-one cancer patients, aged 37 to 76 years, were enrolled onto a prospective, longitudinal, randomized controlled study from the outpatient clinic settings of 26 western Washington–area medical oncologists. A multilevel treatment algorithm based on the Agency for Health Care Policy and Research Guidelines for Cancer Pain Management was compared with standard-practice (control) pain and symptom management therapies used by community oncologists. The primary outcome of interest was pain (Brief Pain Inventory); secondary outcomes of interest were all other symptoms (Memorial Symptom Assessment Scale) and quality of life (Functional Assessment of Cancer Therapy Scale). RESULTS: Patients randomized to the pain algorithm group achieved a statistically significant reduction in usual pain intensity, measured as slope scores, when compared with standard community practice (P < .02). Concurrent chemotherapy and patient adherence to treatment were significant mediators of worst pain. There were no significant differences in other symptoms or quality of life between the two treatment groups. CONCLUSION: This guideline implementation study supports the use of algorithmic decision making in the management of cancer pain. These findings suggest that comprehensive pain assessment and evidence-based analgesic decision-making processes do enhance usual pain outcomes.

Continuous Subcutaneous Infusion of Ketorolac in Cancer Neuropathic Pain Unresponsive to Opioid and Adjuvant Drugs. A Case Report

1996 ◽  
Vol 82 (4) ◽  
pp. 413-415 ◽  
Author(s):  
Carla Ripamonti ◽  
Chiara Ticozzi ◽  
Ernesto Zecca ◽  
Carlos H. Rodriguez ◽  
Franco De Conno
Keyword(s):  
Neuropathic Pain ◽  
Case Report ◽  
Side Effects ◽  
Cancer Patient ◽  
Cancer Pain ◽  
Antidepressant Drugs ◽  
Analgesic Efficacy ◽  
Subcutaneous Infusion ◽  
Continuous Subcutaneous Infusion ◽  
Nonopioid Analgesic

Ketorolac is a new non-steroidal anti-inflammatory drug (NSAID) having a potent nonopioid analgesic activity. Administered by continuous subcutaneous infusion (CSI), its analgesic efficacy has been documented in the treatment of somatic and visceral cancer pain whilst it has been shown to be ineffective in the treatment of neuropathic pain. Here is a description of a cancer patient with neuropathic pain unresponsive to anticonvulsant or antidepressant drugs administered in association or not with oral opioids but who was successfully treated with ketorolac alone via CSI. Furthermore, the analgesia lasted over 75 days of treatment without any significant renal and gastric side effects.

scholarly journals Oral controlled-release morphine sulfate. Analgesic efficacy and side effects of a 100-mg tablet in cancer pain patients

Cancer ◽  
1989 ◽  
Vol 63 (11) ◽  
pp. 2284-2288 ◽  
Author(s):  
Russell K. Portenoy ◽  
Mathelyn Maldonado ◽  
Ronald Fitzmartin ◽  
Robert F. Kaiko ◽  
Ronald Kanner
Keyword(s):  
Controlled Release ◽  
Side Effects ◽  
Cancer Pain ◽  
Analgesic Efficacy ◽  
Morphine Sulfate ◽  
Pain Patients

Ondansetron Is Effective to Treat Spinal or Epidural Morphine-induced Pruritus 

1999 ◽  
Vol 90 (2) ◽  
pp. 432-436 ◽  
Author(s):  
Alain Borgeat ◽  
Hans-Ruedi Stirnemann
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Visual Analog Scale ◽  
Case Reports ◽  
Controlled Study ◽  
Epidural Administration ◽  
Analog Scale ◽  
Double Blind ◽  
Hemoglobin Oxygen Saturation ◽  
Group A

Background Spinally and epidurally administered morphine is frequently associated with pruritus. Isolated case reports indicate that ondansetron may be effective in this context. This study aims to investigate the effectiveness of ondansetron to treat this side effect. Methods In a prospective, randomized, double-blind, placebo-controlled study, 100 patients with pruritus (&gt; 4 on a visual analog scale, on which 0 represents no pruritus and 10 represents worst pruritus imaginable) after spinal or epidural administration of morphine, received either 8 mg ondansetron intravenously (ondansetron group) in 100 ml NaCl 0.9% or vehicle (placebo group). A decrease of more than 4 points on the visual analog scale 60 min after treatment was considered a success. Changes in levels of pain and sedation, hemodynamic values, and other side effects were checked regularly. The presence or absence of pruritus was assessed for the last time 24 h later. Results The two groups were similar for demographic characteristics, the route of administration of morphine, and severity of pruritus at the beginning of the study. The ondansetron group showed a success rate of 70% versus 30% for the placebo group (P &gt; 0.05). Among the successfully treated patients, three (9%) in the ondansetron group and six (40%) in the placebo group reported the recurrence of pruritus (P &lt; 0.05). Among the successfully treated patients, none complained of residual pruritus 24 h later. No changes in pain or sedation levels were noted. Hemodynamic values remained stable, hemoglobin oxygen saturation did not decrease, and no other side effects were observed. Conclusion The administration of 8 mg ondansetron intravenously is an effective treatment for spinally or epidurally administered morphine-induced pruritus. In this clinical condition the treatment is safe and well tolerated.

scholarly journals Melatonin Supplementation for Six Weeks Had No Effect on Arterial Stiffness and Mitochondrial DNA in Women Aged 55 Years and Older with Insomnia: A Double-Blind Randomized Controlled Study

2021 ◽  
Vol 18 (5) ◽  
pp. 2561
Author(s):  
Yonghwan Kim ◽  
Hee-Taik Kang ◽  
Duk-Chul Lee
Keyword(s):  
Insulin Resistance ◽  
Mitochondrial Dna ◽  
Placebo Group ◽  
Arterial Stiffness ◽  
Sleep Quality ◽  
Copy Number ◽  
Quality Index ◽  
Controlled Study ◽  
Double Blind ◽  
Randomized Controlled

Melatonin is a hormone produced in the pineal gland that controls sleep and circadian rhythm. Some studies have reported antioxidant and anti-inflammatory effects of melatonin that could benefit cardiometabolic function; however, there is a lack of evidence to support these assertions. The aim of this study was to investigate whether melatonin has beneficial effects on arterial stiffness and mitochondrial deoxyribonucleic acid (DNA) in humans. Methods: This study was designed as a double-blind randomized controlled study. Thirty-eight healthy women aged 55 years and older were enrolled. All had insomnia (Pittsburgh Sleep Quality Index (PSQI) ≥ 5), not treated with any medications, for at least three months before enrollment. Subjects were divided into a melatonin and a placebo group according to melatonin supplementation. The melatonin group took 2 mg melatonin every night for six weeks. The cardio–ankle vascular index (CAVI) was used as an indicator of arterial stiffness. After six weeks, CAVI, mitochondrial DNA (mtDNA) copy number in white blood cells (WBCs), and other metabolic indices, such as homeostasis model assessment of insulin resistance (HOMA-IR), were checked. Results: Sleep quality index using PSQI was improved in the melatonin group from a score of 11 to 8 (p = 0.01), but did not change significantly in the control group. However, there was no significant intergroup difference in PSQI. Systolic blood pressure (SBP) decreased in the melatonin group from 135 to 128 mmHg (p = 0.015), while remaining stable in the placebo group. Right CAVI, mitochondrial DNA copy number, and HOMA-IR were not altered in either group. There were no intergroup differences in CAVI, mtDNA, HOMA-IR, or SBP between baseline and week six. Conclusions: We found no evidence that melatonin supplementation improved cardiometabolic parameters like arterial stiffness, mtDNA, or insulin resistance compared to the placebo between baseline and week six. Sleep quality was improved in the melatonin group. Further research, including longer-term studies with higher doses of melatonin, is warranted.

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