Targin - efficacy and safety of therapy following conversion from earlier opioid in patients with cancer pain. Observational study report

Ból ◽  
2016 ◽  
Vol 17 (3) ◽  
pp. 11-18
Author(s):  
Elwira Góraj
Keyword(s):  
Observational Study ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Analgesic Efficacy ◽  
Previous Treatment ◽  
Tolerability Profile ◽  
Efficacy And Safety ◽  
Average Pain Intensity ◽  
Average Pain ◽  
Strong Opioids

The aim of the study was evaluation of the efficacy, safety and compliance of the treatment with combination of oxycodone / naloxone (Targin) after the rotation from weak or strong opioid in a multicenter, open, prospective, observational study. Research group consisted of adult patients with chronic, severe cancer pain with presents of symptoms of Opioid Induced Constipation (OIC) associated with the previous treatment were enrolled into the rotation to oxycodone /naloxone (Targin). The study consisted of 4 visits in total, the observation was scheduled for 3 months. The following data were collected: daily dose of oxycodone / naloxone, pain intensity (NRS), adverse effects, number of omitted doses (compliance). After completion of all four visits an assessment of the efficacy and safety of the Targin treatment was made. A reduction in pain intensity (NRS) from baseline of 5.2 (average pain intensity at V1) to 2.1 (average pain intensity for V4) was observed. In sub-groups selected according to previous pain therapy, a reduction in pain intensity out of 5,0 (average pain intensity for V1 in patients treated earlier with strong opioids) to 2.1 (V4) and 5.7 (average pain intensity for V1 in patients treated earlier with weak opioids) to 2.1 (V4). The proportion of patients who did not require laxatives decreased from visit to visit. Patients who received Targin monotherapy after the rotation showed a greater compliance than patients who, in addition to Targin, also were prescribed with another opioid. In the group of patients who completed all four visits, efficacy was assessed as very good or good in 91.7% cases, similarly in 95.8% cases tolerability was evaluated as very good or good. Concluding, rotation to Targin from both, the weak and strong opioids, resulted in a very good and good pain control with reduction in the frequency and severity of OIC. The final result could be multifactorial, but we can confirm the good analgesic efficacy and favorable tolerability profile of Targin with significant reduction of OIC symptoms.

scholarly journals Intravenous Oxycodone versus Intravenous Morphine in Cancer Pain: A Randomized, Open-Label, Parallel-Group, Active-Control Study

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Kyung-Hee Lee ◽  
Jung-Hun Kang ◽  
Ho-Suk Oh ◽  
Moon-Ki Choi ◽  
Byoung-Yong Shim ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Adverse Events ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Rating Scale ◽  
Efficacy And Safety ◽  
Open Label ◽  
Patients With Cancer ◽  
Average Pain Intensity ◽  
Average Pain

Objective. To compare efficacy and safety of intravenous continuous infusion of oxycodone with morphine in patients with cancer pain.Methods. A 5-day, randomized, open-label, exploratory study at 6 sites in the Republic of Korea. Sixty-six adults aged ≥19 years with moderate-to-severe cancer pain (Numeric Rating Scale [NRS] ≥ 4) were enrolled. The study group received intravenous (IV) oxycodone, and the comparator group received IV morphine which were titrated depending on pain intensity. The efficacy endpoint is change in average NRS score from baseline to Day 5. Other assessments included worst, current, and average pain intensity; patient satisfaction; medication dose; and adverse events.Results. Both groups achieved >50% reduction in average pain intensity: from “moderate” at baseline (oxycodone versus morphine: 6.0 ± 1.8 versus 5.9 ± 1.4) to “mild” at Day 5 (2.5 ± 1.8 versus 2.8 ± 1.6). While this reduction was similar between groups (3.5 ± 2.2 versus 3.1 ± 1.8,Pvalue = 0.562), oxycodone achieved faster pain relief (average pain: 3.0 ± 1.6 versus 3.9 ± 1.6,Pvalue = 0.020) on Day 2 and significant NRS reductions for worst pain on Day 2 (Pvalue = 0.045) and current pain on Day 2 (Pvalue = 0.035) and Day 5 (Pvalue = 0.020) compared to morphine. Patient satisfaction, adverse events, and adverse drug reactions were similar for both groups.Conclusions. For Asian patients with cancer pain, IV oxycodone is faster acting and showed similar analgesic efficacy and safety profiles as IV morphine. This trial is registered with Clinicaltrials.govNCT02660229.

scholarly journals Intrathecal betamethasone for cancer pain: A study of its analgesic efficacy and safety

2018 ◽  
Vol 63 (5) ◽  
pp. 659-667
Author(s):  
Hitoshi Taguchi ◽  
Keiko Oishi ◽  
Koh Shingu ◽  
Hideo Matsumoto ◽  
Munehiro Masuzawa
Keyword(s):  
Cancer Pain ◽  
Analgesic Efficacy ◽  
Efficacy And Safety

An Open-Label, Analgesic Efficacy and Safety of Pituitary Radiosurgery for Patients With Opioid-Refractory Pain: Study Protocol for a Randomized Controlled Trial

Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Pain Relief ◽  
Cancer Pain ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Standards Of Care ◽  
Control Group ◽  
Efficacy And Safety ◽  
Open Label

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.

scholarly journals Postoperative topical analgesia of hemorrhoidectomy with policresulen and cinchocaine: a prospective and controlled study

2014 ◽  
Vol 41 (2) ◽  
pp. 92-98 ◽  
Author(s):  
Ilario Froehner Junior ◽  
Paulo Gustavo Kotze ◽  
Juliana Gonçalves Rocha ◽  
Eron Fábio Miranda ◽  
Maria Cristina Sartor ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Bowel Movement ◽  
Controlled Study ◽  
Control Group ◽  
Oral Medications ◽  
Average Pain Intensity ◽  
Average Pain ◽  
The Mean ◽  
Double Blinded ◽  
Topical Analgesia

OBJECTIVE: To evaluate the effects of topical policresulen and cinchocaine in the postoperative pain behavior of open hemorrhoidectomy.METHODS: We conducted a prospective, double-blinded, controlled study. The control group received the usual guidelines with oral medications. The topical treatment group received, in addition, the application of the ointment and was comprised of two subgroups (policresulen + cinchocaine, and placebo). Pain intensity was recorded with the visual analogue scale.RESULTS: 43 patients were operated on: control group - n = 13, one excluded; placebo - n = 15; and policresulen + cinchocaine - n = 15. The mean age was 45.98 years and 37.2% were men. The average pain intensity was 4.09 (immediate postoperative), 3.22 (hospital discharge), 5.73 (day 1) , 5.77 (day 2), 5.74 (day 3), 5.65 (day 7), 5.11 (day 10), 2.75 (day 15) and 7.70 (first bowel movement), with no difference between groups in all periods.CONCLUSION: This study showed no reduction in pain after hemorrhoidectomy with the use of topical policresulen and cinchocaine.

Comparison of Concurrent and Retrospective Pain Ratings during Rehabilitation Following Anterior Cruciate Ligament Reconstruction

2004 ◽  
Vol 26 (4) ◽  
pp. 610-615 ◽  
Author(s):  
Britton W. Brewer ◽  
Allen E. Cornelius ◽  
Judy Van Raalte ◽  
John C. Brickner ◽  
Howard Tennen ◽  
...  
Keyword(s):  
Anterior Cruciate Ligament ◽  
Anterior Cruciate Ligament Reconstruction ◽  
Pain Intensity ◽  
Ligament Reconstruction ◽  
Cruciate Ligament ◽  
Cruciate Ligament Reconstruction ◽  
Average Pain Intensity ◽  
Pain Ratings ◽  
Average Pain ◽  
Anterior Cruciate

The accuracy of retrospective ratings of pain intensity was examined in a sample of 72 men and 36 women undergoing rehabilitation following anterior cruciate ligament (ACL) reconstructive surgery. Participants completed daily ratings of current, worst, and average pain intensity for the first 42 days of rehabilitation. Participants provided retrospective ratings of worst and average pain intensity twice for a 7-day period (on Days 7 and 21) and once for a 30-day period (on Day 30). Correlations between concurrent and retrospective pain ranged from .74 to .88. Retrospective pain ratings consistently overestimated concurrent pain ratings, but were generally not biased by current pain. The results suggest that retrospective pain ratings can substitute for concurrent pain ratings if the tendency toward overestimation is taken into account.

scholarly journals Episodic Cancer Pain: Patient Reporting, Prevalence, and Clinicodemographic Associations at Initial Cancer Pain Clinic Assessment

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Paulo Reis-Pina ◽  
Anand Acharya ◽  
Antonio Barbosa ◽  
Peter G. Lawlor
Keyword(s):  
Cancer Pain ◽  
Pain Intensity ◽  
Brief Pain Inventory ◽  
Cross Sectional Study ◽  
Pain Clinic ◽  
Pain Patient ◽  
Cross Sectional ◽  
Pain Location ◽  
Patient Reported ◽  
Average Pain

Background. Better understanding of the episodic cancer pain (CP) spectrum, including pains that occur in addition to its conventionally defined breakthrough CP (BTcP) and incident CP (IcP) components, may inform CP assessment and management. This study aimed to determine the prevalence of episodic patient-reported CP and the prevalence and associations of study-defined BTcP (S-BTcP) and IcP (S-IcP) in patients with CP. Methods. In a cross-sectional study at their first CP clinic attendance, participants with CP had the following assessments: Brief Pain Inventory (BPI); Pain Management Index (PMI), with PMI-negative status indicating undertreatment; standardized neuropathic pain component (NPC) status; S-BTcP (no trigger identified) and S-IcP (trigger identified) status, based on a preceding 7-day history of transitory pain flares distinct from background pain, and BPI-Worst or BPI-Now pain intensity ≥ 4. Clinicodemographic variables’ association with S-BTcP and S-IcP was examined in logistic regression analyses. Results. Of 371 participants, 308 (83%) had episodic CP by history alone; 140 (37.7%) and 181 (48.8%) had S-BTcP and S-IcP, respectively. Multivariable analyses demonstrated significant (p<0.05) associations (odds ratios: 95% CIs) for 6 variables with S-BTcP: head and neck pain location (2.53; 1.20–5.37), NPC (2.39; 1.34–4.26), BPI average pain (1.64; 1.36–1.99), abdominal pain (0.324; 0.120–0.873), S-IcP (0.207; 0.116–0.369), and PMI-negative status (0.443; 0.213–0.918). Similar independent associations (p<0.05) occurred for S-IcP with NPC, BPI average pain, and PMI-negative status, in addition to radiotherapy, S-BTcP, soft tissue pain, and sleep interference. Conclusions. Episodic or transient patient-reported CP flares often do not meet the more conventional criteria that define BTcP and IcP, the principal episodic CP types. Both BTcP and IcP occur frequently and both are associated with a NPC, higher pain intensity, and less opioid underuse in the management of CP. Further studies are warranted to both better understand the complex presentations of episodic CP and inform its classification.

Validation of Painreportit Neuropathic Pain Scale in African American Adults with Sickle Cell Disease

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 3525-3525 ◽  
Author(s):  
Keesha Roach ◽  
Robert E Molokie ◽  
Zaijie Jim Wang ◽  
Mariam O Ezenwa ◽  
David Shuey ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Neuropathic Pain ◽  
Pain Intensity ◽  
Sickle Cell ◽  
Pain Scale ◽  
Moderate Correlation ◽  
Cell Disease ◽  
Weak Correlation ◽  
Average Pain Intensity ◽  
Average Pain

Abstract Background: Pain in sickle cell disease (SCD) has been thought to be episodic, but more recent evidence has shown that individuals in this population also suffer from chronic pain likely resulting from central or peripheral neural damage (neuropathic pain). There is accumulating evidence from human and animal studies indicating potential neuropathic pain in SCD. A number of valid and reliable measures of neuropathic pain have been used to differentiate neuropathic from non-neuropathic types of pain. PAINReportIt, which takes about 10 to 18 minutes to complete, is a computer based self-report pain assessment tool based on the 1970 version of the McGill Pain Questionnaire. From PAINReportIt, a new subscale has been proposed as a measure of neuropathic pain that sums the number of neuropathic pain quality words selected. The PAINReportIt number of neuropathic pain (PR-NNP) scale, however, lacks validation in patients with SCD. Aim: The purpose of this study was to determine the construct validity for the PR-NNP by examining the associations between the PR-NNP and other valid and reliable measures of neuropathic pain (self-administered Leeds Assessment of Neuropathic Symptoms and Signs [S-LANSS] and the Neuropathic Pain Symptom Inventory [NPSI]) among adults with SCD. We hypothesized that the PR-NNP scores would be significantly correlated with S-LANSS and NPSI scores. Methods: This prospective instrument validation study was conducted in an ambulatory research setting with 79 adults diagnosed with SCD who had chronic pain within the prior 12 months (>3 on a 0-10 pain scale). The sample mean age was 36.0 ± 11.5 [ranged from 19-74 years], 63% were female, and 97% reported they were African American. The participants were asked to complete self-reported pain measures (PR-NNP, S-LANSS, NPSI, and PR-NNoc [number of nociceptive pain words]). Descriptive, correlational, and regression analyses were used. Results: Mean scores for average pain intensity, PR-NNP, NSPI, S-LANSS, and PR-NNoc appear in Table 1. Bivariate results indicated moderate correlation between the two validated measures of neuropathic pain (NPSI and S-LANSS; r= .57, p=.000). The NPSI was moderately correlated with PR-NNP (r= .43, p=.000), and weakly correlated with PR-NNoc (r=.35, p=.002). For S-LANSS, there was a moderate correlation with PR-NNP (r=0.41, p=.000) and a weak correlation with PR-NNoc (r=.30, p=.007). There was a weak correlation between average pain intensity and NPSI and S-LANSS, r=.37, p=.001 and r=.36, p=.001, respectively. Regression analysis including average pain intensity, PR-NNP, and PR-NNoc as predictors showed that controlling for PR-NNP and average pain, PR-NNoc was not significantly associated with either NPSI (p=.930) or S-LANSS (p=.731), while each point of increase in PR-NNP was associated with an increase of 1.9 (p=.004) in NPSI and of 0.8 (p=.003) in S-LANSS. The same analysis showed that a one point increase in the average pain intensity was associated with an increase of 2.7 (p=.001) in NPSI and of 1.0 (p=.001) in S-LANSS. Conclusions: Both average pain intensity and PR-NNP but not PR-NNoc have unique explanatory properties of both indicators of neuropathic pain (NPSI and S-LANSS). These findings support the construct validity of the PR-NNP as a potential screening tool for neuropathic pain in patients with SCD. Validation of PR-NNP is important for future neuropathic pain research in the sickle cell population, particularly in cases of multi-site trials, and in cases where the practitioner can detect the potential presence of neuropathic pain without use of expensive equipment. These findings are important because pain management in the sickle cell population often includes opioids, but easy and early detection of neuropathic pain could result in an opioid sparing pain management approach in this population. Disclosures No relevant conflicts of interest to declare.

scholarly journals Double-blind, pragmatic, randomized placebo-controlled trial of 8-week self-administered at-home behavioral skills-based virtual reality (VR) for chronic low back pain (during COVID-19) (Preprint)

2020 ◽  
Author(s):  
Beth Darnall ◽  
Laura Garcia ◽  
Brandon Birckhead ◽  
Parthasarathy Krishnamurthy ◽  
Ian Mackey ◽  
...  
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Pain Intensity ◽  
Chronic Low Back Pain ◽  
User Satisfaction ◽  
Pain Catastrophizing ◽  
Controlled Trial ◽  
Low Back ◽  
Average Pain Intensity ◽  
Average Pain

BACKGROUND Chronic low back pain is the most prevalent chronic pain condition worldwide and access to behavioral pain treatment is limited. Virtual reality (VR) is an immersive technology that may provide effective behavioral therapeutics for chronic pain. OBJECTIVE To conduct a double-blind, parallel arm, single cohort, remote, randomized placebo-controlled trial for a self-administered behavioral skills-based VR program in community-based individuals with self-reported chronic low back pain during the COVID-19 pandemic. METHODS A national online convenience sample of individuals with self-reported non-malignant low back pain > 6 months duration and with average pain intensity > 4/10 was enrolled and randomized 1:1 to one of two 56-day VR programs: (1) EaseVRx (pain relief skills immersive VR program); or (2) Sham VR (2D nature content delivered in a VR headset). Objective device use data and self-reported data were collected. The primary outcomes were change in average pain intensity and pain-related interference with activity, stress, mood, and sleep (baseline to end-of-treatment at day 56). Secondary outcomes were global impression of change and change in physical function, sleep disturbance, pain self-efficacy, pain catastrophizing, pain acceptance, pain medication use, and user satisfaction. Analytic methods included intention-to-treat and a mixed-model framework. RESULTS The study sample was 179 adults (female: 77%; Caucasian: 91%; at least some college education: 92%; mean age: 51.5 years, SD=13.1; average pain intensity: 5/10, SD=1.2; back pain duration >5 years: 67%). No group differences were found for any baseline variable or treatment engagement. User satisfaction ratings were higher for EaseVRx vs. Sham VR (p<0.0001). Both groups improved significantly for all five primary outcomes; EaseVRx was superior to Sham VR for all primary outcomes except pain-related sleep interference. For EaseVRx, large pre-post effect sizes ranged from 1.06-1.3 and met moderate to substantial clinical importance for reduced pain intensity and pain-related interference with activity, mood, and stress. A greater proportion of participants in the EaseVRx group achieved > 30% reduction in pain intensity (EaseVRx: 65.5%; Sham VR: 40.5%), and 46% of EaseVRx achieved >50% reduction in pain. Physical function and sleep disturbance significantly improved for both treatment groups with superior improvements found for EaseVRx (p=0.0019 and p=.0353, respectively). Pain catastrophizing, pain self-efficacy, prescription opioid use (morphine milligram equivalent; MME) did not reach statistical significance for either group. Use of over-the-counter analgesic use was reduced for EaseVRx (p<0.01) but not for Sham VR. CONCLUSIONS EaseVRx had high user satisfaction and superior and clinically meaningful symptom reduction for average pain intensity and pain-related interference with activity, mood, and stress compared to sham VR. Additional research is needed to determine durability of treatment effects and to characterize mechanisms of treatment effects. Home-based VR may expand access to effective and on-demand non-pharmacologic treatment for chronic low back pain. CLINICALTRIAL ClinicalTrials.gov, NCT04415177 https://clinicaltrials.gov/ct2/show/NCT04415177 INTERNATIONAL REGISTERED REPORT RR2-25291

scholarly journals Structural and functional biomarkers of efficacy of navigated repetitive transcranial magnetic stimulation in therapy for trigeminal neuralgia

2021 ◽  
Author(s):  
AG Poydasheva ◽  
DO Sinitsyn ◽  
IS Bakulin ◽  
NA Suponeva ◽  
MA Piradov
Keyword(s):  
Transcranial Magnetic Stimulation ◽  
Trigeminal Neuralgia ◽  
Pain Intensity ◽  
Magnetic Stimulation ◽  
Repetitive Transcranial Magnetic Stimulation ◽  
Cerebellar Hemisphere ◽  
Average Pain Intensity ◽  
Postcentral Gyrus ◽  
Average Pain ◽  
Positive Correlations

Repetitive transcranial magnetic stimulation (rTMS) is an alternative treatment option for patients with drug-resistant trigeminal neuralgia (TN). However, the effect of rTMS is variable. The aim of this study was to find neuroimaging biomarkers of clinical efficacy of navigated rTMS. Seventeen patients with TN (14 women and 3 men, median age 56 years) received 10 sessions of high-frequency rTMS of the motor cortex contralateral to pain side. The data were analyzed for correlations between functional connectivity (FC), the grey matter (GM) volume and the reduction in pain intensity. Positive correlations were established between the reduction in average pain intensity and GM volume in caudate nuclei in both hemispheres (p(unc) = 0.03), both cerebellar hemispheres (p(unc) = 0.002) and the postcentral gyrus contralateral to pain side (p(unc) = 0.005); between the reduction in peak pain intensity and GM volume in the caudate nucleus contralateral to pain side (p(unc) = 0.04) and the cerebellar hemisphere ipsilateral to pain (p(unc) = 0.03). Significant positive correlations were discovered between the reduction in average pain intensity and FC between the thalamus contralateral to pain side, the postcentral gyrus and the insular operculum (both ipsilateral to pain side; (p(FWE) = 0.018), as well as between the cingulate cortex and the anterior cingulate cortex ipsilateral to pain (p(FWE) = 0.017), between the contralateral subcallosal gyrus and the cerebellar hemisphere ipsilateral to pain (p(FWE) = 0.018). A negative correlation was established for FC between the contralateral putamen and the occipital lobes in both hemispheres (p(FWE) = 0.001). Our findings may spur the development of individual predictors of rTMS efficacy in patients with chronic pain.

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