Role of rectal route in treating cancer pain: a randomized crossover clinical trial of oral versus rectal morphine administration in opioid-naive cancer patients with pain.

1995 ◽  
Vol 13 (4) ◽  
pp. 1004-1008 ◽  
Author(s):  
F De Conno ◽  
C Ripamonti ◽  
L Saita ◽  
T MacEachern ◽  
J Hanson ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Cancer Patients ◽  
Rectal Administration ◽  
Liquid Solution ◽  
Onset Of Action ◽  
Double Blind ◽  
Rectal Route ◽  
Significant Difference ◽  
Opioid Administration ◽  
Morphine Hydrochloride

PURPOSE The aim of this double-blind, double-dummy, crossover study was to compare the efficacy, tolerability, and time of onset of analgesia after the administration of 10 mg of morphine hydrochloride via the oral and rectal routes in opioid-naive cancer patients with pain. PATIENTS AND METHODS Thirty-four patients with cancer pain and no previous opioid treatment were randomized to receive morphine hydrochloride 10 mg orally or rectally (in the form of a microenema) for 2 days. During days 3 and 4, a crossover took place. The scores of pain, nausea, and sedation (visual analog scale of 0 to 100) calculated as the percentage change from baseline (before opioid administration) were assessed at different intervals up to 240 minutes. The number of vomiting episodes was recorded. Parity tests and analysis of variance (ANOVA) were performed to compare the two administration routes. RESULTS A significant difference in pain intensity was achieved 10 minutes after rectal administration compared with 60 minutes after oral administration. There was still a significant reduction in pain via the rectal route after 180 minutes versus via the oral route after 120 minutes. No significant difference was observed in the intensity of sedation, nausea, or number of vomiting episodes between the oral and rectal routes. CONCLUSION A liquid solution of morphine is well absorbed via the rectal route. Rectal morphine is safe, effective, easy to manage, and inexpensive, with a rapid onset of action. Rectal morphine can be considered a valid alternative route for opioid administration and may also be used when rescue doses of morphine are required in patients regularly treated with oral or parenteral opioids.

Economic evaluation of the randomised, double-blind, placebo-controlled study of subcutaneous ketamine in the management of chronic cancer pain

2018 ◽  
Vol 33 (1) ◽  
pp. 74-81 ◽  
Author(s):  
Nikki McCaffrey ◽  
Thomas Flint ◽  
Billingsley Kaambwa ◽  
Belinda Fazekas ◽  
Debra Rowett ◽  
...  
Keyword(s):  
Palliative Care ◽  
Cost Effectiveness ◽  
Cancer Pain ◽  
Sensitivity Analyses ◽  
Controlled Study ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Cost Effective Treatment ◽  
Significant Difference ◽  
The Cost

Background: Treating chronic, uncontrolled, cancer pain with subcutaneous ketamine in patients unresponsive to opioids and co-analgesics remains controversial, especially in light of recent evidence demonstrating ketamine does not have net clinical benefit in this setting. Aim: To evaluate the cost-effectiveness of subcutaneous ketamine versus placebo in this patient population. Design and setting: A within-trial cost-effectiveness analysis of the Australian Palliative Care Clinical Studies Collaborative’s randomised, double-blind, placebo-controlled trial of ketamine was conducted from a healthcare provider perspective. Mean costs and outcomes were estimated from participant-level data over 5 days including positive response, health-related quality of life (HrQOL) measured with the Functional Assessment of Chronic Illness Therapy–Palliative Care (FACIT-Pal), ketamine costs, medication usage and in-patient stays. Results: There was no statistically significant difference in responder rates, but higher toxicity and worse HrQOL for ketamine participants (mean change −3.10 (standard error (SE) 1.76), ketamine n = 93; 4.53 (SE 1.38), placebo n = 92). Estimated total mean costs were AU$706 higher per ketamine participant (AU$6608) compared with placebo (AU$5902), attributable to the cost of higher in-patient costs as well as costs of ketamine administration. The results were robust to sensitivity analyses accounting for different medication use costing methods and removal of cost outliers. Conclusion: The findings suggest subcutaneous ketamine in conjunction with opioids and standard adjuvant therapy is neither an effective nor cost-effective treatment for refractory pain in advanced cancer patients.

Amitriptyline in Neuropathic Cancer Pain in Patients on Morphine Therapy: A Randomized Placebo-controlled, Double-blind Crossover Study

2002 ◽  
Vol 88 (3) ◽  
pp. 239-242 ◽  
Author(s):  
Sebastiano Mercadante ◽  
Edoardo Arcuri ◽  
Walter Tirelli ◽  
Patrizia Villari ◽  
Alessandra Casuccio
Keyword(s):  
Quality Of Life ◽  
Neuropathic Pain ◽  
Adverse Effects ◽  
Cancer Pain ◽  
Pain Intensity ◽  
Cancer Patients ◽  
Double Blind ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

Aims and Background Amitriptyline is the most common analgesic adjuvant used in cancer patients with neuropathic pain, even though no specific studies have demonstrated a benefit. A randomized placebo-controlled, double-blind crossover study was designed to evidence the effects of amitriptyline in patients with neuropathic cancer pain. Methods Sixteen advanced cancer patients with neuropathic pain on systemic morphine therapy, no longer receiving oncologic treatment, presenting moderate pain (about 4 or more, but less than 7, on a numerical scale of 0-10) in the last week, and given a stable morphine dose in the last 2 days were admitted to the study. During the first week of study, patients were administered 25 mg of amitriptyline or equivalent drops of placebo at night for 3 days and 50 mg for the following 4 days. Doses for patients aged more than 65 years were 15 mg (first 3 days) and 30 mg (3 days after). After a week, a crossover took place for the second week, with the other treatment at an inverse sequence. Opioid consumption, pain intensity, symptoms and adverse effects, mood, sleep, patient's preference, quality of life before starting the study, the first week after and the second week after were recorded. Results No significant benefits in analgesia were found in the global pain intensity of the previous week of treatment, the least pain intensity or the pain evaluated just after a week of treatment, at the moment of the visit, when amitriptyline was compared with placebo. A significant difference was evidenced for the worst pain (P < 0.035). No differences in opioid doses during the period of study were found. Drowsiness, confusion and dry mouth were significantly more intense with amitriptyline than with placebo (P < 0.036, 0.003, and 0.034, respectively). There were no substantial differences between the two treatments in Spitzer's quality of life score and for each item. No differences in patients' preference for the two treatment periods were found. The analgesic effects of amitriptyline were slight and associated with adverse effects. Conclusions In light of the results obtained in the study, the extensive use of the drug for cancer pain should be questioned.

scholarly journals The addition of omeprazole to ondansetron for treating chemotherapy-induced nausea and vomiting in pediatric cancer patients

2018 ◽  
Vol 1 (1) ◽  
pp. 42
Author(s):  
Perjuangan Dapot Hamonangan Simbolon ◽  
Selvi Nafianti ◽  
Pertin Sianturi ◽  
Bidasari Lubis ◽  
Aznan Lelo
Keyword(s):  
Placebo Group ◽  
Cancer Patients ◽  
Pediatric Cancer ◽  
Controlled Trial ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
Chi Square ◽  
Double Blind ◽  
Significant Difference ◽  
Pediatric Cancer Patients

Background Chemotherapy-induced nausea and vomiting are some of the most disturbing side effects in pediatric cancer patients. The standard recommendation is the use of 5-hydroxytryptamine 3 receptor antagonist, such as ondansetron, to treat these symptoms. Despite this treatment, more than 50% of patients still experience nausea and vomiting.Objective To evaluate the effect of the addition of omeprazole to ondansetron in the treatment of chemotherapy-induced nausea and vomiting.Methods A double-blind, randomized, controlled trial was conducted at Haji Adam Malik Hospital, Medan, North Sumatera, from March to May 2016. Subjects were children aged 1 to 18 years, diagnosed with cancer, and who received intravenous chemotherapy. Patients were randomized to receive either a single dose of ondansetron (0.5 mg/kg) plus placebo or ondansetron (0.5 mg/kg) plus omeprazole (0.5 mg/kg). The severity of nausea and vomiting were measured using the Rhodes index of nausea, vomiting, and retching during the 24 hours after initiation of emetogenic chemotherapy. The primary outcome of efficacy was the proportion of patients who achieved complete response (lack of nausea/vomiting). Statistical analysis was performed by Chi-square and Fischer’s exact tests.Results Seventy eligible pediatric patients were randomized into two groups: 32 subjects in the ondansetron + placebo group and 38 others in the ondansetron + omeprazole group. The therapy failed in 50% (16/32) of the ondansetron + placebo group and 18.4% (7/38) of the ondansetron + omeprazole group. There was a significant difference in the clinical response between groups (P=0.01).Conclusion The addition of omeprazole to ondansetron for the treatment of chemotherapy-induced nausea and vomiting is more effective than administration of ondansetron alone.

Communicating the introduction of psychology services in the palliative care (PC) cancer setting: A randomized double blind trial.

2018 ◽  
Vol 36 (34_suppl) ◽  
pp. 129-129
Author(s):  
Sujin Ann-Yi ◽  
Kimberson Cochien Tanco ◽  
Cindy L. Carmack ◽  
Diane D. Liu ◽  
Swati Bansal ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Depression Scale ◽  
Empirical Support ◽  
Double Blind ◽  
Psychosocial Services ◽  
Significant Difference ◽  
Scale Scores ◽  
High Distress ◽  
Cancer Setting ◽  
Clinical Trial Information

129 Background: Despite high distress and empirical support for psychosocial services for cancer patients, the utilization of these services continue to be low. Our aims are to ascertain if the manner of introducing psychology services impact patients’ acceptance of services and identify factors associated with acceptance and barriers of psychology utilization. Methods: 100 PC cancer patients who have not received prior psychology services were randomized to observe two video vignettes: one showed a physician introducing a counselor and psychology services to the patient (PI); another showed a counselor entering and introducing psychology services alone (CI). Randomization was stratified using baseline Hospital Anxiety and Depression Scale scores. After viewing both videos, patients completed a survey regarding preference, attitudes, and barriers for psychology services. Patients were blinded regarding the purpose of the study and investigators were blinded to content and order of videos presented. Results: 64 patients reported a preference with 34 preferring PI (p=0.37) and 36 reporting no difference. Younger patients preferred PI (85.7%) versus CI (14.3%, p=0.03). Most reported being aware of available psychology services (N=63), and half (N=50) had been offered psychology services by their physician. Only 40 (40%) patients felt psychology services would be helpful for them, and 43 (43%) reported it would be beneficial for their family/caregivers. Those who found it helpful for themselves or family had higher anxiety than those who did not find it helpful (p=0.03 and p=.02 respectively). The most commonly endorsed barriers for psychology services were travel (N=25) and finances (N=21). Conclusions: We found no significant difference in preference of introduction of psychology services except in patients less than 40 years old who preferred PI. Patients with higher anxiety felt psychology services were helpful for self and family. Only 40% perceived psychology services as useful for self and family. More research is needed to investigate the most effective approach for introducing psychology services to increase perception of usefulness and utilization in cancer patients. Clinical trial information: NCT03035448.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Toxicity of Subcutaneous Ketamine in the Management of Cancer Pain

2012 ◽  
Vol 30 (29) ◽  
pp. 3611-3617 ◽  
Author(s):  
Janet Hardy ◽  
Stephen Quinn ◽  
Belinda Fazekas ◽  
John Plummer ◽  
Simon Eckermann ◽  
...  
Keyword(s):  
Cancer Pain ◽  
Positive Outcome ◽  
Phase Iii ◽  
Additional Patient ◽  
Controlled Study ◽  
Net Benefit ◽  
Primary Analysis ◽  
Double Blind ◽  
Number Of Patients ◽  
Significant Difference

Purpose The anesthetic ketamine is widely used for pain related to cancer, but the evidence to support its use in this setting is weak. This study aimed to determine whether ketamine is more effective than placebo when used in conjunction with opioids and standard adjuvant therapy in the management of chronic uncontrolled cancer pain. Ketamine would be considered of net benefit if it provided clinically relevant improvement in pain with limited breakthrough analgesia and acceptable toxicity. Patients and Methods In this multisite, dose-escalation, double-blind, randomized, placebo-controlled phase III trial, ketamine or placebo was delivered subcutaneously over 3 to 5 days. Results In all, 185 participants were included in the primary analysis. There was no significant difference between the proportion of positive outcomes (0.04; 95% CI, −0.10 to 0.18; P = .55) in the placebo and intervention arms (response rates, 27% [25 of 92] and 31% [29 of 93]). Pain type (nociceptive v neuropathic) was not a predictor of response. There was almost twice the incidence of adverse events worse than baseline in the ketamine group after day 1 (incidence rate ratio, 1.95; 95% CI, 1.46 to 2.61; P < .001) and throughout the study. Those receiving ketamine were more likely to experience a more severe grade of adverse event per day (odds ratio, 1.09; 95% CI, 1.00 to 1.18; P = .039). The number of patients needed to treat for one additional patient to have a positive outcome from ketamine was 25 (95% CI, six to ∞). The number needed to harm, because of toxicity-related withdrawal, was six (95% CI, four to 13). Conclusion Ketamine does not have net clinical benefit when used as an adjunct to opioids and standard coanalgesics in cancer pain.

Comparison of Pimozide and Chlorpromazine in Acute Schizophrenia

1982 ◽  
Vol 27 (3) ◽  
pp. 208-212 ◽  
Author(s):  
J.C. Pecknold ◽  
D.J. Mcclure ◽  
T. Allan ◽  
L. Wrzesinski
Keyword(s):  
Dopamine Receptor ◽  
Adverse Reactions ◽  
Rating Scale ◽  
Double Blind Study ◽  
Onset Of Action ◽  
Double Blind ◽  
Acute Schizophrenia ◽  
Significant Difference ◽  
Psychiatric Rating ◽  
Psychiatric Rating Scale

A four week double-blind study comparing pimozide and chlorpromazine was designed to test the hypothesis that pimozide, a powerful dopamine receptor blocker, is more effective in the treatment of acute schizophrenia than chlorpromazine. Twenty patients, 13 males and 7 females ranging in age from 21 to 53 years (mean age 33 years) admitted to St. Mary's Hospital with acute schizophrenia were placed on the study. They were treated on an individual titrated dosage of either chlorpromazine 300 mg to 2100 mg, or pimozide 10 to 70 mg. The results revealed that on the Brief Psychiatric Rating Scale, the chlorpromazine group significantly improved after one week, whereas the pimozide group showed no statistical improvement until the third week. By the end of the study no significant differences were apparent between the two groups. In the Clinical Global Impression Scale, a significant difference between the two groups was found at week 4 showing a greater improvement in the chlorpromazine group. In terms of adverse reactions, the chlorpromazine group had significantly fewer extrapyramidal symptoms than the pimozide group (Simpson and Angus Scale) and in addition 15 adverse reactions were noted for the pimozide group as compared with 8 for the chlorpromazine group. This study shows that chlorpromazine has an earlier onset of action than pimozide in the acute schizophrenic patient despite the fact that it has a weaker effect on the dopamine receptor than has pimozide. In view of this finding, the dopamine theory of schizophrenia should be critically re-examined.

Safety of transdermal fentanyl (TF) in front-line approach to severe cancer pain. Meta-analysis of randomized clinical trials

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19627-19627
Author(s):  
M. Maltoni ◽  
E. Scarpi ◽  
B. Poggi ◽  
D. Tassinari
Keyword(s):  
Side Effects ◽  
Adverse Effects ◽  
Cancer Pain ◽  
Safety Profile ◽  
Mesh Term ◽  
Phase Iii ◽  
Front Line ◽  
Significant Difference ◽  
Opioid Administration ◽  
Gastrointestinal Side Effects

19627 Background: To assess the safety of TF when compared with Slow Releasing Oral Morphine (SROM) in the front-line approach to severe cancer pain. Methods: A systematic review of literature in the MEDLINE and EMBASE data bases from 1966 to October 2006, using “Administration, Cutaneous” [MeSH term], “Administration, Oral” [MeSH term], “Analgesic, Opioid/*administration & dosage/adverse effects” [MeSH term], “Delayed-Action Preparations” [MeSH term], “Fentanyl/*administration & dosage/adverse effects” [MeSH term], “Cancer Pain/*drug therapy” [MeSH term], “Morphine/*administration & dosage/adverse effects” [MeSH term] as search terms was performed independently by two authors (DT and MM). All the randomized phase III trials comparing TF and SROM were considered eligible and included into the analysis. The overall side effects odds ratio (OR) was the primary end point of the analysis; overall gastrointestinal side effects, constipation, nausea, somnolence, the patient's preference and the trial withdrawal pooled ORs the secondary ones. Heterogeneity between the trials was analysed using the Mantel-Haenszel test, and the outcome analysis was performed using a fixed effects model and an alpha error lower than 5%. Results: 3 trials met the selection criteria and were included into the analysis. The safety of TF and SROM was analysed in 373 patients (188 and 185 respectively treated with TF and SROM). A significant difference in favour of TF was observed for constipation (OR=0.42, p=0.002), somnolence (OR=0.559, p=0.018) and the preference of the patient (OR=0.39, p<0.001): no significant differences were observed for overall side effects (OR=0.82, p=0.51), overall gastrointestinal side effects (OR=0.87, p=0.6), nausea (OR=1.2, p=0.446) and trial withdrawal (OR=0.62, p=0.59). No heterogeneity was documented between the trials. Conclusion: Although no differences exist between TF and SROM in efficacy (with equianalgesic doses) and safety (when assessed as overall safety profile) on the whole, the differences in the peculiar safety profile of the two opiates seems to favour TF in patient's preference in the choice of front-line treatment of severe cancer pain. No significant financial relationships to disclose.

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.

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