Randomized Trial of Low-Dose Morphine Versus Weak Opioids in Moderate Cancer Pain

2016 ◽  
Vol 34 (5) ◽  
pp. 436-442 ◽  
Author(s):  
Elena Bandieri ◽  
Marilena Romero ◽  
Carla Ida Ripamonti ◽  
Fabrizio Artioli ◽  
Daniela Sichetti ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Low Dose ◽  
Assessment System ◽  
Controlled Study ◽  
Moderate Pain ◽  
Morphine Group ◽  
Patients With Cancer ◽  
Weak Opioid

Purpose The WHO guidelines on cancer pain management recommend a sequential three-step analgesic ladder. However, conclusive data are lacking as to whether moderate pain should be treated with either step II weak opioids or low-dose step III strong opioids. Patients and Methods In a multicenter, 28-day, open-label randomized controlled study, adults with moderate cancer pain were assigned to receive either a weak opioid or low-dose morphine. The primary outcome was the number of responder patients, defined as patients with a 20% reduction in pain intensity on the numerical rating scale. Results A total of 240 patients with cancer (118 in the low-dose morphine and 122 in the weak-opioid group) were included in the study. The primary outcome occurred in 88.2% of the low-dose morphine and in 57.7% of the weak-opioid group (odds risk, 6.18; 95% CI, 3.12 to 12.24; P < .001). The percentage of responder patients was higher in the low-dose morphine group, as early as at 1 week. Clinically meaningful (≥ 30%) and highly meaningful (≥ 50%) pain reduction from baseline was significantly higher in the low-dose morphine group (P < .001). A change in the assigned treatment occurred more frequently in the weak-opioid group, because of inadequate analgesia. The general condition of patients, which was based on the Edmonton Symptom Assessment System overall symptom score, was better in the morphine group. Adverse effects were similar in both groups. Conclusion In patients with cancer and moderate pain, low-dose morphine reduced pain intensity significantly compared with weak opioids, with a similarly good tolerability and an earlier effect.

scholarly journals Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

2019 ◽  
Vol 79 (2) ◽  
pp. 276-284 ◽  
Author(s):  
Edward Roddy ◽  
Kris Clarkson ◽  
Milica Blagojevic-Bucknall ◽  
Rajnikant Mehta ◽  
Raymond Oppong ◽  
...  
Keyword(s):  
Primary Care ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Low Dose ◽  
Rating Scale ◽  
Randomised Trial ◽  
Pragmatic Trial ◽  
Open Label ◽  
Gout Flare ◽  
Gout Flares

ObjectivesTo compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.MethodsThis was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0–10 Numeric Rating Scale) from baseline measured daily over the first 7 days: mean change from baseline was compared between groups over days 1–7 by intention to treat.ResultsBetween 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1–7 (colchicine vs naproxen: mean difference −0.18; 95% CI −0.53 to 0.17; p=0.32). During days 1–7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54).ConclusionWe found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications.Trial registration numberISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

Tramadol: Does it have a role in cancer pain management?

2005 ◽  
Vol 1 (3) ◽  
pp. 131 ◽  
Author(s):  
Eric E. Prommer, MD
Keyword(s):  
Neuropathic Pain ◽  
Adverse Effects ◽  
Cancer Pain ◽  
Drug Interactions ◽  
Low Dose ◽  
World Health ◽  
Cancer Pain Management ◽  
Patients With Cancer ◽  
The World ◽  
Dual Mechanism

Tramadol (Ultram, Ortho-McNeil Pharmaceutical, Inc., Raritan, NJ) is considered a Step 2 analgesic under the World Health Organization’s guidelines for the treatment of patients with cancer pain. It is a centrally acting analgesic that has affinity for opioid receptors and influences the action of norepinephrine and serotonin at the synapse. This dual mechanism of analgesia makes it unique among Step 2 agents. It is metabolized by CYP2D6, which increases the potential for drug interactions. Unlike other opioids, it does not cause respiratory depression. Tramadol has been studied in cancer pain and neuropathic pain. It compares well with low-dose morphine as an analgesic. The purpose of this review is to critically examine the pharmacodynamics, pharmacology, drug interactions, and adverse effects of the drug, and, based on the data presented, discuss the drug’s role in cancer care.

A randomized controlled trial (RCT) of 2 dose ratios for conversion from parenteral to oral methadone in patients with cancer pain.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 206-206
Author(s):  
Jesus Gonzalez-Barboteo ◽  
Josep Porta-Sales ◽  
Maria Nabal-Vicuña ◽  
Leyre Diez-Porres ◽  
Jaume Canal ◽  
...  
Keyword(s):  
Side Effects ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Controlled Trial ◽  
Oral Route ◽  
Dose Ratio ◽  
Double Blind ◽  
Patients With Cancer ◽  
Significant Difference ◽  
Lower Ratio

206 Background: Methadone (M) is frequently used for severe cancer pain using the parenteral and oral route. The most commonly used dose ratio (DR) parenteral: oral is 1:2. However, methadone is highly bioavailable and a lower ratio might result in similar analgesia with less toxicity. The main objective of this RCT is to compare success and side effects with 2 ratios of parenteral to oral M: 1:2 vs 1:1.2 in hospitalized patients with cancer pain. Methods: Inpatients with cancer pain well controlled with parenteral M requiring rotation to the oral route. Double blind RCT. Outcomes included pain intensity (BPI), opioid toxicity (CTCAE), and M dose. Success was defined as good pain control with no toxicity at 72hs. Results: 39/44 randomized patients were evaluable (89%): 21 in DR 1:2 and 18 in DR 1:1.2. 71% male, median age 65. No significant difference between DR1:2 and DR1:1.2 in frequency of neuropathic pain (64 Vs 68%), Papscore A/B (100 Vs 91%), CAGE + (23 Vs 18%). Median M dose pre/post was 24.5mg±13.5 y 49 mg±27.3 for DR 1:2, Vs 23.3mg±9.4 (p: NS) y 28mg±11.3 (p < 0.01) for DR 1:1.2. The DR1:2 group developed more cumulative toxicity at dasy 1, 2 and 3 (p < 0.015, p < 0.006 y p < 0.001 respectively). Pain intensity pre/ post was: 1.58±1.3 and 0.87±1.0, ns for DR 1:2, Vs 1.13±0.7 (p:NS) and 1.07±0.9 (p:NS) for DR 1:1.2. Success was observed in 12 pts in DR1:2 Vs 18 in DR 1:1.2, p < 0.001. Side effects related to M were observed in 33/46 pts in DR 1:2 (mainly neurotoxicity symptoms) Vs 1/6 in DR 1:1.2. Conclusions: DR 1:1.2 when changing from parenteral to oral M resulted in lower toxicity and no difference in analgesia. More conservative dose adjustment during M route change should be considered. Granted by Spanish Ministry of Health EC10-133. EUDRACT Number: 2010-024092-39. Clinical trial information: 2010-024092-39.

Clinical efficacy and safety of a novel controlled-release morphine suppository and subcutaneous morphine in cancer pain: a randomized evaluation.

1995 ◽  
Vol 13 (6) ◽  
pp. 1520-1527 ◽  
Author(s):  
E Bruera ◽  
R Fainsinger ◽  
K Spachynski ◽  
N Babul ◽  
Z Harsanyi ◽  
...  
Keyword(s):  
Controlled Release ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Clinical Efficacy ◽  
Oral Morphine ◽  
Mcgill Pain Questionnaire ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Patients With Cancer ◽  
Significant Difference

PURPOSE A significant number of cancer patients will require an alternate route of morphine administration at some point during their illness. This study compared the clinical efficacy and safety of a novel morphine sulfate controlled-release suppository (MS-CRS) and subcutaneous (SC) morphine in patients with cancer pain. METHODS Thirty patients with cancer pain were randomized in a double-blind crossover study to MS-CRS every 12 hours or SC morphine every 4 hours for 4 days each, using a 2.5:1 analgesic equivalence ratio. Pain intensity was assessed using a visual analog scale (VAS) and the Present Pain Intensity Index of the McGill Pain Questionnaire. Nausea and sedation were also assessed with a VAS. Evaluations were made by the patient at 8 AM, noon, 4 PM, and 8 PM and rescue morphine consumption recorded. RESULTS Twenty-three patients completed the study (13 men and 10 women; mean age, 64.0 +/- 2.0 years) and were treated with mean daily MS-CRS and SC morphine doses of 326 +/- 69 mg and 138 +/- 28 mg, respectively. There was a small but significant difference in overall ordinal pain-intensity scores in favor of MS-CRS (0.7 +/- 0.1 v 0.9 +/- 0.1, P = .0459). There were no significant differences between MS-CRS and SC morphine in overall VAS scores for pain intensity (13 +/- 3 v 13 +/- 3 mm), sedation (23 +/- 3 v 25 +/- 4 mm), and nausea (8 +/- 2 v 9 +/- 2 mm). The mean daily rescue analgesic consumption during MS-CRS and SC morphine did not differ significantly (1.2 +/- 0.4 v 1.2 +/- 0.4 doses/d). CONCLUSION MS-CRS, administered every 12 hours, provides analgesia comparable to SC morphine and represents a reliable, noninvasive alternative method of pain control for patients unable to take oral morphine.

scholarly journals Comparative Efficacy of Therapeutics for Chronic Cancer Pain: A Bayesian Network Meta-Analysis

2019 ◽  
Vol 37 (20) ◽  
pp. 1742-1752 ◽  
Author(s):  
Rongzhong Huang ◽  
Lihong Jiang ◽  
Yu Cao ◽  
Hongli Liu ◽  
Minsheng Ping ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Meta Analysis ◽  
Secondary Outcome ◽  
Chronic Cancer Pain ◽  
Published Evidence ◽  
Nonopioid Analgesics ◽  
Inflammatory Drugs ◽  
Anti Inflammatory

PURPOSE Opioids are the primary choice for managing chronic cancer pain. However, many nonopioid therapies are currently prescribed for chronic cancer pain with little published evidence comparing their efficacy. METHODS Electronic databases were searched for randomized controlled trials (RCTs) comparing any systemic pharmaceutical intervention and/or combination thereof in treating chronic cancer pain. The primary outcome was global efficacy reported as an odds ratio (OR). The secondary outcome was change in pain intensity reported as a standardized mean difference (SMD). RESULTS We included 81 RCTs consisting of 10,003 patients investigating 11 medication classes. Most RCTs (80%) displayed low risk of bias. The top-ranking classes for global efficacy were nonopioid analgesics (network OR, 0.30; 95% credibility interval [CrI], 0.13 to 0.67), nonsteroidal anti-inflammatory drugs (network OR, 0.44; 95% CrI, 0.22 to 0.90), and opioids (network OR, 0.49; 95% CrI, 0.27 to 0.86), whereas the top-ranked interventions were lidocaine (network OR, 0.04; 95% CrI, 0.01 to 0.18; surface under the cumulative ranking curve analysis [SUCRA] score, 98.1), codeine plus aspirin (network OR, 0.22; 95% CrI, 0.08 to 0.63; SUCRA score, 81.1), and pregabalin (network OR, 0.29; 95% CrI, 0.08 to 0.92; SUCRA score, 73.8). In terms of reducing pain intensity, we found that no class was superior to placebo, whereas the following top-ranked interventions were superior to placebo: ziconotide (network SMD, −24.98; 95% CrI, −32.62 to −17.35; SUCRA score, 99.8), dezocine (network SMD, −13.56; 95% CrI, −23.37 to −3.69; SUCRA score, 93.5), and diclofenac (network SMD, −11.22; 95% CrI, −15.91 to −5.80; SUCRA score, 92.9). CONCLUSION There are significant differences in efficacy among current regimens for chronic cancer pain. Our evidence suggests that certain nonopioid analgesics and nonsteroidal anti-inflammatory drugs can serve as effectively as opioids in managing chronic cancer pain.

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