Opioid titration with sustained-release oxycodone and immediate-release morphine for moderate/severe cancer pain: A pilot assessment of the CoDem protocol

2014 ◽  
Vol 10 (1) ◽  
pp. 29 ◽  
Author(s):  
Boaz Gedaliahu Samolsky Dekel, MD, PhD, MA ◽  
Marco Tomasi, MD ◽  
Alessio Vasarri, MD ◽  
Alberto Gori, MD ◽  
Marco Adversi, MD ◽  
...  

Objectives: Opioid titration is the first challenging stage for rapid control of moderate/severe cancer pain. Evidence shows that sustained-release formulations may be used for opioid titration. We set a pilot assessment of the efficacy and tolerability of our in-house protocol (continuous and on demand opioids [CoDem]) of the association of sustained-release oxycodone and immediate-release morphine as rescue dose for opioid titration/rotation in opioid-naïve (NAOP, n = 13), tolerant to weak (WOP, n = 20), or strong opioids (STOP, n = 44) in-patients with moderate/severe cancer pain.Methods: Observational and retrospective analysis of cancer in-patients treated for ≥7 days with the CoDem protocol.Outcome measures: Pain intensity (patients self-reported pain with numerical rating scale [NRS] under static [NRSs] and dynamic [NRSd] conditions), amount of drug consumption, opioid adverse effects, and patient satisfaction.Efficacy endpoints: In more than 50 percent of the patients and in <72 hours, steady NRSs and NRSd score reduction of at least two points, NRSs ≤ 3 and NRSd ≤4; and mean daily morphine consumption < mean of one rescue dose and t1:t6 ratio of mean oxycodone daily dose < 1:2.Results: Endpoints were reached within 24 hours both within the sample and subgroups. Only NAOP patients reached NRSd ≤ 4 endpoint within 48 hours. Against moderate and transient adverse effects, most patients (84.4 percent) found pain treatment to be good or excellent.Conclusions: The CoDem protocol was shown to be effective and reasonably tolerated for titration for moderate/severe cancer pain relief in both opioid-naïve or opioid-tolerant cancer in-patients. This pilot assessment warrants prospective and comparative studies with larger samples for more generalized results.

2014 ◽  
Vol 10 (2) ◽  
pp. 85 ◽  
Author(s):  
Giuseppe Melilli, MD ◽  
Boaz Gedaliahu Samolsky Dekel, MD, PhD, MA ◽  
Catia Frenquelli, MD ◽  
Rita Mellone, MD ◽  
Franco Pannuti, MD

Objectives: As guidelines for opioid use in renal-impaired patients with cancer are limited, the authors sought to assess the efficacy, safety, and tolerability, of transdermal buprenorphine for moderate/severe cancer pain in renal-impaired outpatients.Methods: In a prospective parallel-group active-controlled study, n = 42 consecutively recruited outpatients with or without renal impairment (serum creatinine >=1.3 or <=1.2 mg/dL, respectively) were treated with transdermal buprenorphine (group BUP) or fentanyl (group FEN), respectively. Patients were followed up, at home, by the nonprofit ANT-Italia-foundation physicians in Bologna, Italy. Measurements at 10 (T1), 30 (T2), and 90 (T3) days after enrollment (T0) were pain intensity (Numerical Rating Scale [NRS]), Karnofski score, opioid dose (µg/h), rescue-dose consumption, and occurrence of adverse effects. Patients recorded subjective measurements in a personal diary. Upon data analysis, investigators were blinded to the patient group.Results: At T0, in groups BUP and FEN, median NRS score was 8.0 (CI, 7.4-8.4); its reduction over time (T3; NRS = 3.0; CI, 2.1-3.8 and 2.0-4.0, respectively) was significant and constant in both groups (t-test; T0-T1, T1-T2, and T2-T3; p < 0.0001, p < 0.001, and p < 0.05, respectively). At all times, there were no significant differences in pain scores between the groups. In all evaluations, adverse effects were reported n = 73/126 times (60.8 percent) and showed no significant association (χ2, p > 0.05) with the study groups. Conclusions: Transdermal buprenorphine, in outpatients with cancer and renal impairment, is as effective, safe, and tolerable as fentanyl in patients without such impairment. These results add further evidence to the notion that buprenorphine, with its peculiar pharmacokinetics, may be an appropriate choice for opioid treatment in patients with renal impairment.


2020 ◽  
Vol 10 (4) ◽  
pp. 429-434 ◽  
Author(s):  
Marlise Poolman ◽  
Matthew Makin ◽  
Jess Briggs ◽  
Kate Scofield ◽  
Nick Campkin ◽  
...  

ObjectivesPercutaneous cervical cordotomy (PCC) is an interventional ablative procedure in the armamentarium for cancer pain treatment, but there is limited evidence to support its use. This study aimed to assess the effectiveness and safety of PCC.MethodsAnalysis was undertaken of the first national (UK) prospective data repository of adult patients with cancer undergoing PCC for pain treatment. The relationship between pain and other outcomes before and after PCC was examined using appropriate statistical methods.ResultsData on 159 patients’ PCCs (performed from 1 January 2012 to 6 June 2017 in three centres) were assessed: median (IQR) age was 66 (58–71) years, 47 (30%) were female. Mesothelioma was the most common primary malignancy (57%). The median (IQR) time from cancer diagnosis to PCC assessment was 13.3 (6.2–23.2) months; PCC to follow-up was 9 (8–25) days; and survival after PCC was 1.3 (0.6–2.8) months. The mean (SD) for ‘average pain’ using a numerical rating scale was 6 (2) before PCC and 2 (2) at follow-up, and for ‘worst pain’ 9 (1) and 3 (3), respectively. The median (IQR) reduction in strong opioid dose at follow-up was 50% (34–50). With the exception of ‘activity’, all health-related quality of life scores (5-level version of EuroQol-5 Dimension) either improved or were stable after PCC. Six patients (4%) had PCC-related adverse events.ConclusionsPCC is an effective treatment for cancer pain; however, findings in this study suggest PCC referrals tended to be late in patients’ disease trajectories. Further study into earlier treatment and seeking international consensus on PCC outcomes will further enhance opportunities to improve patient care.


2010 ◽  
Vol 113 (5) ◽  
pp. 1186-1191 ◽  
Author(s):  
Patricia M. Lavand'homme ◽  
Fabienne Roelants

Introduction Late termination of pregnancy combines psychological distress with severe physical pain. The present study evaluated the benefit of adding oral pregabalin to epidural analgesia during this procedure. Methods Healthy women were randomly allocated to receive either oral pregabalin 150 mg/12 h or prazepam 10 mg/12 h at the induction of the late termination of pregnancy procedure. When they felt abdominal pain (numerical rating scale ranging from 0 [no pain] to 100 [worst pain possible]), patient-controlled epidural analgesia was activated and set to deliver ropivacaine 0.1% with sufentanil 0.25 μg/ml, 5 ml/h with a bolus dose of 5 ml/30 min. Rescue analgesia was available as needed by administration of 10 ml ropivacaine 0.1% (pain score less than 60/100) or 0.2% (at least 60/100). The primary outcome was the consumption of epidural analgesics. Results Forty-eight patients participated in the study. Demographic and obstetric data were similar. Pregabalin reduced total ropivacaine consumption 11.3 ± 3.2 mg/h (mean ± SD) versus 15.1 ± 4.9 mg/h in the prazepam group (P = 0.005), an effect related to a decrease in the need for rescue analgesia. In the pregabalin group, fewer women asked for rescue dose (75 vs. 96%; P = 0.048), and the number of rescue doses per patient was reduced (1 [0-2] vs. 2 [1-3]); median [interquartile range], P = 0.005), particularly the need for ropivacaine 0.2%. Discussion This is the first study considering the use of pregabalin for labor pain associated with late termination of pregnancy, showing that pregabalin 150 mg/12 h is a helpful adjuvant to epidural analgesia. Modulation of both visceral sensitization and affective component of pain may contribute to the benefits observed.


2020 ◽  
Vol 5;23 (9;5) ◽  
pp. 495-506
Author(s):  
Prof. Sushma Bhatnagar

Background: Pain is still a common feature in all types of cancers including head and neck and thoracic cancer. Neuromodulatory techniques have gained popularity over opioids in recent times because of the risks associated with chronic opioid therapy. There are no clinical trials evaluating the efficacy of scrambler therapy (ST) for the management of pain due to head and neck and thoracic cancer. Objective: This trial was undertaken to evaluate the efficacy of scrambler therapy (ST) for pain relief and to assess the possible effect of ST on the dosage of opioids in patients suffering from cancer pain. Study design: A randomized control trial (RCT) was performed. Setting: The trial was conducted at the Pain and Palliative Care Unit of the Dr. B.R. Ambedkar Institute Rotary Cancer Hospital of All India Institute of Medical Sciences, New Delhi, India. Method: Forty patients were included in each of the 2 arms, control and Intervention. In both arms, patients were given pain management drugs. In the intervention group, patients additionally received 10 consecutive sessions of ST with one follow-up after 7 days. A numeric rating scale (NRS-11) was used to measure pain. Drug dosage was also recorded. Results: Overall, pain decreased in both arms. However, pain decreased more in the intervention arm as compared to the control arm. The total change in the mean score of the NRS-11 from baseline to follow-up was 3.1 and 6.19 in the control and ST arms, respectively. Differences between pain scores in both arms became significant from day 3 onwards. Mean morphine dose was significantly lower in the intervention arm from day 7 onwards. Limitations: The study followed the patients until one week after the last treatment session and encouraged patients to return for treatment if their pain returned to previous levels within 10 days. Moreover, patients in the control arm received the standard of care in the form of pharmacological treatment but did not receive either transcutaneous electrical nerve stimulation (TENS) or a sham (placebo) procedure. Conclusions: The trial showed that ST is an effective treatment for the management of pain due to head and neck and thoracic cancer. On the basis of this study, the use of ST for the management of refractory cancer pain in head and neck and thoracic cancer is recommended. Key words: Calmare Therapy, cancer pain, noninvasive pain treatment, numerical rating scale, opioids, RCT, scrambler therapy, TENS


F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 1440
Author(s):  
Cristina López de San Román-Fernández ◽  
Carles Fernández-Jané ◽  
Maite Cusidó ◽  
Lluís Costa-Tutusaus

Background: Breast cancer is one of the most prevalent cancers worldwide. Fortunately, survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy. However, this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety. Some studies have reported that acupuncture could be an effective treatment to control these types of symptoms, although only few studies have been conducted on women undergoing mastectomy.  Methods:  This is a pragmatic randomized controlled trial with blind assessors. The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona (Spain).  A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. The main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. Secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications. Discussion: Acupuncture is a low-cost non-pharmacological strategy. This study will help to clarify its possible role in controlling post-mastectomy adverse effects. Trial registration: ClinicalTrials.gov NCT04608175 29/10/2020


2021 ◽  
Vol 9 (2) ◽  
Author(s):  
Reza Khalifeh ◽  
Armin Zareian ◽  
Nafiseh Hosseini Yekta

: To study the effect of four interventions on lower back pain (LBP) alongside time and to identify whether changes in nutrition and doing traditional Persian remedies (massage and rubbing white Lily oil) could relieve the LBP using a short-time treatment. The population of this study consisted of 89 subjects with chronic LBP collected in traditional Persian medicine clinics. The outcomes were two indices for LBP, Oswestry disability index (ODI), and numerical rating scale (NRS), measured three times with an interval of four weeks. Age was not an effective variable in both LBP indices. Effective interventions for both indices are almost the same. For ODI, sex (= male), nutrition, massage, using White Lily oil, and time had decreasing effects on ODI, but interactions of sex with nutrition and massage had increasing effects on ODI. For NRS, sex (= female), using White Lily oil, time, and interactions of sex with massage and nutrition had decreasing effects, but nutrition, massage, and interactions of sex with White Lily oil had increasing effects on NRS.


F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 1440
Author(s):  
Cristina López de San Román-Fernández ◽  
Carles Fernández-Jané ◽  
Maite Cusidó ◽  
Lluís Cosata-Tutusaus

Background: Breast cancer is one of the most prevalent cancers worldwide. Fortunately, survival has improved in recent years thanks to its early detection and curative treatments such as mastectomy. However, this medical procedure is associated with a range of unwanted effects such as postoperative pain and anxiety. Some studies have reported that acupuncture could be an effective treatment to control these types of symptoms, although only few studies have been conducted on women undergoing mastectomy.  Methods:  This is a pragmatic randomized controlled trial with blind assessors. The study will be conducted in the Breast Unit of Hospital Universitario Sagrado Corazon of Barcelona (Spain).  A sample of 40 women will be recruited and randomized to receive acupuncture treatment in addition to standard care procedures, or standard care procedures alone. The main outcome, pain, will be assessed after the surgical intervention and 4, 10 and 30 days later using the numerical rating scale. Secondary outcomes include anxiety, use of analgesics, nausea, adverse effects, and surgical complications. Discussion: Acupuncture is a low-cost non-pharmacological strategy. This study will help to clarify its possible role in controlling post-mastectomy adverse effects. Trial registration: ClinicalTrials.gov NCT04608175 29/10/2020


2021 ◽  
Vol 9 (01) ◽  
pp. 181-185
Author(s):  
Ashwin Mathur ◽  
◽  
Avikesh Agarwal ◽  

Pain is a distressing symptom of cancer that affects the quality of life of patients, families, and caregivers. Moderate to severe pain is common throughout the disease trajectory of cancer, and its prevalence increases throughout the course of illness, it has been reported in 59% of patients undergoing anticancer treatment, in 64% of those with advanced/metastatic cancer, and in 33% of those having completed curative treatment. Adequate management of cancer pain is the cornerstone of symptom management for patients with cancer. [1] WHO guidelines on cancer pain continue to provide a framework approach for pharmacologic management of cancer pain management in terms of a Pain Ladder, wherein Step 1 for mild pain is prescribed NSAIDS, Step 2 for moderate pain is prescribed NSAIDS along with synthetic opioids and adjuvants and step 3 for severe pain is prescribed strong opioids like Morphine along with NSAIDS and adjuvants. Morphine being an excellent analgesic for severe pain is nowadays standard of care for terminal cancer patients with severe pain. However, its potency is a double edged sword and can give rise to side effects as well as much feared adverse effects. This study was undertaken to assess the undesirable effects on cancer patients being treated with Morphine. AIM To find the association of morphine and its adverse effects (by 4 point verbal rating scale) in cancer patient on long term morphine therapy. MATERIAL AND METHODS It is a hospital based longitudinal observational study, conducted in palliative care center, SMS hospital, Jaipur, after obtaining due approval from ethics committee and research review board of the institution. DURATION OF STUDY: One year. TOTAL PATIENTS: 30 patients evaluated one month after initiation of opioid therapy. ELIGIBILITY CRITERIA: Inclusion criteria 1. Cancer patients visiting palliative care OPD for distressing, somatic symptom like pain requiring treatment with strong opioids (step 3 WHO ladder). 2. Patients of all ages and both sexes. 3. Patients willing to give informed consent 4. Patients who understand the four point symptom rating scale. Exclusion Criteria: 1. Patients with deranged liver and kidney functions. 2. Patient with predominantly neuropathic pain. 3. Patients with altered sensorium. 4. Patient not willing to give informed consent.


2020 ◽  
pp. bmjspcare-2019-002175
Author(s):  
Christina Tan ◽  
Jade Fui Wong ◽  
Choon Meng Yee ◽  
Allyn Hum

ContextMethadone is a useful option in the treatment of cancer pain. Despite its advantages, methadone use is complicated due to high interindividual variability in pharmacokinetics. Various rotation methods from other opioids have been proposed in mostly Caucasian populations.ObjectivesThis study aims to describe our experience with opioid rotation to methadone for management of cancer pain in a predominantly Asian population.MethodsA retrospective review of 52 inpatients initiated on methadone for cancer pain from June 2015 to June 2018 was conducted. Our institution protocol for methadone rotation involves either one of two methods (‘Stop-and-go’ or the Edmonton 3-day rotation) based on the morphine-equivalent daily dose (MEDD), using an equianalgesic ratio of 10:1 for MEDD <1000 mg. To account for incomplete cross-tolerance, we further reduce the calculated dose by 30%.ResultsThe majority of patients had mixed nociceptive-neuropathic pain (83%) and the predominant reason for methadone rotation was ineffective analgesia with other opioids (75%). The median MEDD before rotation was 104 mg. Effective analgesia (defined as a decrease in numerical rating scale (NRS) of ≥1 or attainment of NRS ≤3) was achieved within 3 days after rotation in 89% of patients. Patients with an MEDD ≤100 mg/day required a greater degree of uptitration of methadone dose after rotation compared with those with an MEDD >100 mg/day.ConclusionRotation to methadone according to our protocol is effective in achieving adequate analgesia in most patients experiencing nociceptive-neuropathic pain. Our results also suggest that a fixed equianalgesic ratio of 10:1 may be adequate for patients at low-to-moderate MEDD <400 mg/day.


2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Ying Huang ◽  
Xihan Li ◽  
Tong Zhu ◽  
Jian Lin ◽  
Gaojian Tao

Objective. Although intrathecal drug infusion has been commonly adopted for terminal cancer pain relief, its adverse effects have made many clinicians reluctant to employ it for intractable cancer pain. The objective of this study is to compare the efficacy and security of an intrathecal continuous infusion of morphine and ropivacaine versus intrathecal morphine alone for cancer pain.Methods. Thirty-six cancer patients received either a continuous morphine (n=19) or morphine and ropivacaine (n=17) infusion using an intrathecal catheter through a subcutaneous port. Numerical Rating Scale (NRS) scores and the Barthel Index were analyzed. Adverse effects and complications on postoperative days 1, 3, 7, and 15 were also analyzed.Results. All patients experienced pain relief. Compared to those who received morphine alone, patients receiving morphine and ropivacaine had significantly lower postoperative morphine requirements and higher Barthel Index scores on the 15th postsurgical day (P<0.05). Patients receiving morphine and ropivacaine had lower NRS scores than patients receiving morphine alone on postoperative days 1, 3, 7, and 15 (P<0.05). Negative postsurgical effects were similar in both groups.Conclusions. Morphine and ropivacaine administration through intrathecal access ports is efficacious and safe and significantly improves quality of life.


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