Double-Blind Crossover Clinical and Pharmacokinetic Comparison of Oral Morphine Syrup and Sustained Release Morphine Sulfate Capsules in Patients with Cancer-Related Pain

1997 ◽  
Vol 14 (Supplement 1) ◽  
pp. 22-27 ◽  
Author(s):  
Jean-François Gillette ◽  
Christophe Ferme ◽  
Nancy Moisy ◽  
Laurent Mignot ◽  
Roger Schach ◽  
...  
Keyword(s):  
Sustained Release ◽  
Oral Morphine ◽  
Morphine Sulfate ◽  
Double Blind ◽  
Patients With Cancer

scholarly journals Regular, sustained-release morphine for chronic breathlessness: a multicentre, double-blind, randomised, placebo-controlled trial

Thorax ◽  
2019 ◽  
Vol 75 (1) ◽  
pp. 50-56 ◽  
Author(s):  
David Currow ◽  
Sandra Louw ◽  
Philip McCloud ◽  
Belinda Fazekas ◽  
John Plummer ◽  
...  
Keyword(s):  
Sustained Release ◽  
Primary Endpoint ◽  
Controlled Trial ◽  
Oral Morphine ◽  
Immediate Release ◽  
Morphine Group ◽  
Double Blind ◽  
Intention To Treat ◽  
Palliative Care Services ◽  
Secondary Endpoints

IntroductionMorphine may decrease the intensity of chronic breathlessness but data from a large randomised controlled trial (RCT) are lacking. This first, large, parallel-group trial aimed to test the efficacy and safety of regular, low-dose, sustained-release (SR) morphine compared with placebo for chronic breathlessness.MethodsMultisite (14 inpatient and outpatient cardiorespiratory and palliative care services in Australia), parallel-arm, double-blind RCT. Adults with chronic breathlessness (modified Medical Research Council≥2) were randomised to 20 mg daily oral SR morphine and laxative (intervention) or placebo and placebo laxative (control) for 7 days. Both groups could take ≤6 doses of 2.5 mg, ‘as needed’, immediate-release morphine (≤15 mg/24 hours) as required by the ethics review board. The primary endpoint was change from baseline in intensity of breathlessness now (0–100 mm visual analogue scale; two times per day diary) between groups. Secondary endpoints included: worst, best and average breathlessness; unpleasantness of breathlessness now, fatigue; quality of life; function; and harms.ResultsAnalysed by intention-to-treat, 284 participants were randomised to morphine (n=145) or placebo (n=139). There was no difference between arms for the primary endpoint (mean difference −0.15 mm (95% CI −4.59 to 4.29; p=0.95)), nor secondary endpoints. The placebo group used more doses of oral morphine solution during the treatment period (mean 8.7 vs 5.8 doses; p=0.001). The morphine group had more constipation and nausea/vomiting. There were no cases of respiratory depression nor obtundation.ConclusionNo differences were observed between arms for breathlessness, but the intervention arm used less rescue immediate-release morphine.Trial registration numberACTRN12609000806268.

Efficacy and safety of transdermal fentanyl and sustained-release oral morphine in patients with cancer and chronic non-cancer pain

2004 ◽  
Vol 20 (9) ◽  
pp. 1419-1428 ◽  
Author(s):  
A. J. Clark ◽  
S. H. Ahmedzai ◽  
L. G. Allan ◽  
F. Camacho ◽  
G. L. A. Horbay ◽  
...  
Keyword(s):  
Sustained Release ◽  
Cancer Pain ◽  
Oral Morphine ◽  
Efficacy And Safety ◽  
Transdermal Fentanyl ◽  
Patients With Cancer

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.

Placebo-blinded study of morphine sulfate sustained-release tablets and immediate-release morphine sulfate solution in outpatients with chronic pain due to advanced cancer.

1993 ◽  
Vol 11 (5) ◽  
pp. 967-972 ◽  
Author(s):  
J W Finn ◽  
T D Walsh ◽  
N MacDonald ◽  
E Bruera ◽  
L U Krebs ◽  
...  
Keyword(s):  
Chronic Pain ◽  
Sustained Release ◽  
Advanced Cancer ◽  
Side Effect ◽  
Breakthrough Pain ◽  
Karnofsky Performance Status ◽  
Performance Status ◽  
Oral Morphine ◽  
Immediate Release ◽  
Morphine Sulfate

PURPOSE This study was conducted to compare the relative analgesic efficacy and safety of an every-4-hour immediate-release oral morphine (IRM) solution with that of an every-12-hour sustained-release oral morphine (SRM) formulation. PATIENTS AND METHODS This was a double-blind, placebo-blinded, crossover study in 34 adult male and female outpatients with pain due to advanced cancer. Baseline data were collected on day 1. On days 2 and 3, randomly assigned patients received either placebo plus IRM (Roxanol; Roxane Laboratories, Inc, Columbus, OH; 20 mg/mL) at 2, 6, and 10 am, and 2, 6, and 10 pm, or alternatively SRM (Oramorph SR; Roxane Laboratories, Inc; 30 mg) at 10 AM and 10 PM. Patients were then crossed over to the alternate treatment for days 4 through 6. Pain relief was measured using a conventional 100-mm visual analog scale (VAS) and by recording the incidence of breakthrough pain. Information on side effects was obtained from VAS scores for sedation, nausea, anxiety, and depression; by directly questioning the patient as to mental confusion, bowel movements, and laxative use; and from Karnofsky performance status scores. VAS data were analyzed using a linear statistical model. Breakthrough pain data were analyzed using analysis of variance (ANOVA). RESULTS There were no statistically significant differences between IRM and SRM treatments with respect to VAS pain scores, side effect scores, or incidence of breakthrough pain data. Karnofsky performance scores remained stable for all patients throughout the study. CONCLUSION It was concluded that every-12-hour administration of SRM and every-4-hour administration of IRM provide similar analgesic effectiveness and side effect profiles in the treatment of chronic pain in cancer patients.

Acetaminophen (Paracetamol) Improves Pain and Well-Being in People With Advanced Cancer Already Receiving a Strong Opioid Regimen: A Randomized, Double-Blind, Placebo-Controlled Cross-Over Trial

2004 ◽  
Vol 22 (16) ◽  
pp. 3389-3394 ◽  
Author(s):  
Martin Stockler ◽  
Janette Vardy ◽  
Avinesh Pillai ◽  
David Warr
Keyword(s):  
Advanced Cancer ◽  
Oral Morphine ◽  
Well Being ◽  
Double Blind ◽  
Opioid Dose ◽  
Patients With Cancer ◽  
Strong Opioid ◽  
Visual Analog Scales ◽  
Strong Opioids ◽  
Numeric Scale

Purpose To determine whether adding regular acetaminophen (paracetamol) could improve pain and well-being in people with advanced cancer and pain despite strong opioids. Patients and Methods Participants took acetaminophen for 48 hours and placebo for 48 hours. The order (acetaminophen or placebo first) was randomly allocated. Pain was the primary outcome. Preferences, number of opioid breakthrough doses, overall well-being, nausea and vomiting, drowsiness, constipation, and cold sweats were secondary outcomes. Patients rated themselves daily with visual analog scales (VAS) and a verbal numeric scale (VNS) for pain, all scaled from 0 to 10. Results Thirty patients completed the trial. The oral opioid was morphine in 23 patients and hydromorphone in seven patients. The median daily opioid dose in oral morphine equivalents was 200 mg (range, 20 to 2,100 mg). Nonsteroidal anti-inflammatory drugs, corticosteroids, or both were used by 16 patients. Pain and overall well-being were better for patients receiving acetaminophen than for those receiving placebo. The mean difference was 0.4 (95% CI, 0.1 to 0.8; P = .03) in VNS for pain, 0.6 (95% CI, −0.1 to 1.3; P = .09) in VAS for pain, and 0.7 (95% CI, 0.0 to 1.4; P = .05) in VAS for overall well-being. More patients preferred the period they took acetaminophen (n = 14) than the period they took placebo (n = 8), but many had no preference (n = 8). There were no differences in the other outcomes. Conclusion Acetaminophen improved pain and well-being without major side effects in patients with cancer and persistent pain despite a strong opioid regimen. Its addition is worth considering in all such patients.

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