Rectal versus oral morphine for the management of cancer pain. A double-blind, double dummy, crossover trial

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.

Download Full-text

SAT0124 Comparative safety and efficacy of transdermal fentanyl (durogesic®) and sustained-release oral morphine (ms contin®) in patients with chronic non-cancer pain: results of a large, multicenter, randomised, crossover trial

10.1136/annrheumdis-2001.557 ◽

2001 ◽

Author(s):

L Allan ◽

E Kalso

Keyword(s):

Sustained Release ◽

Cancer Pain ◽

Crossover Trial ◽

Oral Morphine ◽

Transdermal Fentanyl ◽

Safety And Efficacy ◽

Comparative Safety

Download Full-text

Clinical Efficacy and Safety of Once-Daily Dosing of a Novel, Prolonged-Release Oral Morphine Tablet Compared With Twice-Daily Dosing of a Standard Controlled-Release Morphine Tablet in Patients With Cancer Pain: A Randomized, Double-Blind, Exploratory Crossover Study

Journal of Pain and Symptom Management ◽

10.1016/j.jpainsymman.2009.08.013 ◽

2010 ◽

Vol 39 (4) ◽

pp. 712-720 ◽

Cited By ~ 17

Author(s):

Derry Ridgway ◽

Maciej Sopata ◽

Arvydas Burneckis ◽

Lillian Jespersen ◽

Christine Andersen

Keyword(s):

Controlled Release ◽

Cancer Pain ◽

Crossover Study ◽

Clinical Efficacy ◽

Oral Morphine ◽

Prolonged Release ◽

Efficacy And Safety ◽

Double Blind ◽

Once Daily ◽

Patients With Cancer

Download Full-text

Injectable Ketoprofen VS. Acetylsalicylic Acid for the Relief of Severe Cancer Pain: A Double-Blind, Crossover Trial

Drug Intelligence & Clinical Pharmacy ◽

10.1177/106002808401800510 ◽

1984 ◽

Vol 18 (5) ◽

pp. 403-406 ◽

Cited By ~ 10

Author(s):

Gabriele Sacchetti ◽

Paolo Camera ◽

Andrea Paolo Rossi ◽

Andrea Martoni ◽

Giancarlo Bruni ◽

...

Keyword(s):

Cancer Pain ◽

Acetylsalicylic Acid ◽

Crossover Trial ◽

Double Blind

Download Full-text

THE PHARMACOKINETICS OF SUSTAINED-RELEASE MORPHINE TABLETS AND ORAL MORPHINE SOLUTION A MULTICENTRE DOUBLE-BLIND CROSSOVER TRIAL

Anesthesia & Analgesia ◽

10.1213/00000539-198702001-00160 ◽

1987 ◽

Vol 66 (Supplement) ◽

pp. S160 ◽

Cited By ~ 4

Author(s):

P. A. Sloan ◽

M. Thirlwell ◽

J. Maroun ◽

J. G. Besner

Keyword(s):

Sustained Release ◽

Crossover Trial ◽

Oral Morphine ◽

Double Blind ◽

Morphine Solution

Download Full-text

The efficacy, tolerability, and speed of onset of fentanyl pectin nasal spray (FPNS) in the treatment of breakthrough cancer pain (BTCP): A multicenter, placebo-controlled, double-blind, two-phase crossover study

Journal of Clinical Oncology ◽

10.1200/jco.2009.27.15_suppl.9535 ◽

2009 ◽

Vol 27 (15_suppl) ◽

pp. 9535-9535

Author(s):

N. Y. Gabrail ◽

A. W. Burton ◽

E. Reyes ◽

A. Nguyen ◽

D. R. Taylor

Keyword(s):

Cancer Pain ◽

Pain Intensity ◽

Nasal Spray ◽

Time Course ◽

Oral Morphine ◽

Nasal Delivery ◽

Intensity Difference ◽

Double Blind ◽

Pain Intensity Difference ◽

Breakthrough Cancer Pain

9535 Background: Breakthrough cancer pain (BTCP) affects up to 95% of patients with cancer pain but oral fentanyl formulations do not consistently match the typical time course of BTCP, which is rapid in onset and lasts for 30–60 min. To tailor fentanyl delivery for the treatment of BTCP, a new nasal formulation of fentanyl (fentanyl pectin nasal spray [FPNS]) has been developed to provide both rapid and controlled nasal delivery of fentanyl. Methods: A randomised, placebo-controlled, double-blind (DB) study assessing the efficacy and tolerability of FPNS was conducted in 114 cancer patients experiencing 1–4 BTCP episodes/day while taking ≥60 mg/day of oral morphine (or equivalent) for cancer pain. Patients who completed a titration phase (N=83) continued to a DB phase where 10 episodes of BTCP were treated with the effective dose identified during titration (7) or placebo (3). Pain intensity (PI) was measured using an 11-point categorical scale and pain relief (PR) using a 5-point scale, both PI and PR were measured at 5, 10, 15, 45 and 60 min post-dose. The primary endpoint was the Summed Pain Intensity Difference at 30 min (SPID30min). Secondary efficacy endpoints included Pain Intensity Difference (PID) from baseline, PI and PR. Safety was assessed by adverse events (AEs) and both objective and subjective nasal assessments. Results: Compared with placebo, FPNS significantly improved mean SPID30min scores (P<0.0001) and significantly improved SPID scores as early as 10 min (P<0.05) and up to 60 min (P<0.0001). Significant differences in favour of FPNS were found in PI as early as 5 min (P<0.05). Similar benefits were also seen with PID, with a trend at 5 min (P=0.07) that was significant from 10 min onward (P<0.01). PR was significant from 10 min (P<0.001) and at all time points to 60 min (P<0.001). Only 5.3% of patients withdrew from titration due to AEs; no significant nasal effects were reported. Conclusions: FPNS provided rapid and effective analgesia in BTCP and was generally safe and well tolerated. [Table: see text]

Download Full-text