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The clinical evaluation of the compassionate use of oral transmucosal fentanyl citrate (OTFC) for the treatment of breakthrough cancer pain
s353
Poster 139 RED Th-Fri Exhibit Hall
THE CLINICAL EVALUATION OF THE COMPASSIONATE USE OF ORAL TRANSMUCOSAL FENTANYL CITRATE (OTFC) FOR THE TREATMENT OF BREAKTHROUGHCANCER PAIN. E29. m, L. Olson, P.F. Fine, T.H. Stanley*, Acute Pain Service, Dept of Anesthesiology, University of Utah, Salt Lake City, Utah, U.S.A.
Abs No 679 AIM OF VTION, We report on the initial results of an ongoing study to detamine whether OTFC canbesuccessfully used to control breakthrough cancer pain as compared to an oral morphine solution in an open randomized trial. METHODS: This research study involves 10 cancer patients who suffer from significant breakthrough cancer pain m-spite of maxhnal conventional pain therapy. Patients in the study continue current cancer and pain management therapies. OTFC (15-20 mcgkg) and oral morphine (25-75 mg) is used for the treatment of brealttbrough pain in an open, random&d trial (Table 1). Bach patient is given a diary to record pain medications, pain assessment and any adverse effects. ‘lhe patient assesses his/her pain using the Visual Analog Scale and O-10Numeric Scale four times a day throughout the study. In addition, pain is assessed 30 mhi before and 30 mitt after using OTFC or morphine for the treatment of bmakkougbpain. RESULTS: Two patients have completed the study to date. The results are summarixed in Fig. 1 and 2. The addition of both OTFC and oral morphine solution decreased overall pain experience as documented by daily VAS (Fig. 1). In addition, both OTFC and cual morphine were effective in providing analgesia for breakthrough pain. However, the onset of analgesia with OTFC was shorter than seen with the oral morphhie solution (Fig. 2). CONCLU~ Both OTFC and oral morphine solution provide analgesia for breaktlu~ugh cancer pain. However, OTFC offers the potential advantages of providing titratable analgesia with a more rapid onset time. Further data are necessary to identify OTFCs role in treatment of breakthrough cancer pain. TABLE 1. TREATMENT PROTOCOL JX=gwGrouDn baseliie 1 : 4 2 7
baseline morphine K: morphine baseline baseliie morphme OTFC Z%Y
BASBLINE -MGRPElM -GlK
l-
Ze
g ’
morphme morphine
=
’ BR&FAST
L&Ii
DMER
TIME OF DAY Figure 1
BEDTIME
r O-3
3-S
ONSET
OF
A DOUBLE-BLIND COMPARISON OF MULTIPLE DOSE REGIMEN OF KETOROLAC AND BUPRENORPHINE IN PATIENTS WITH CANCER PAIN. M. Sta uet*l and G. De Wasch*2 (SPON: P. Ewalenko), IInstitut Jules dussels, Belgium ; 2Ziekenhuis Henri Seruys, Oostende, Belgium. AIM OF THE INVESTIGATION: To compare the analgesic efficacy and adverse effects of IM ketorolac (10 mg and 30 mg) with those of buprenorphine (0.3 mg) when the drugs are administered for 3 days.
1
S-10 lo-15 15-3030-45 45-60 N3 REum ANALGESIA
Figure
(MINUTES) 2
Poster 140 RED Th-Fri Exhibit Hall Abs No
680
METHODS: The trial is a double-blind, multidose, double observer, parallel study in three grm 40 patients experiencing moderate to severe pain. Informed consent was given in all cases. The study medications were administered as required by the patient by a nurse not involved in the evaluation of the results. Patients were asked to rate pain severity and pain relief on a verbal standard scale. Patterns of usage, duration of efficacy, acceptance, side-effects, global evaluation were also investigated at preselected times. RESULTS: At the end of the trial, the patients' overall opinion was fair to excellent in 92me cases with buprenorphine and ketorolac 10 mg and in 83% with ketorolac 30 mg (NS). The investigator's global evaluation was 94% for buprenorphine and 89% for both doses of ketorolac (NS). On day 1, complete pain relief was seen in 22% of the subjects with buprenorphine, in 24% with ketorolac 10 mg and in 22% with ketorolac 30 mg (NS). Comparable relative frequencies were observed for day 2 and day 3. When considering the scores for moderate or complete relief, 80% of the patients were classified in one of these categories. Side-effects were seen more often with buprenorphine (17% of the cases) than with ketorolac 30 mg (3%) or ketorolac 10 mg (0%) (p C 0.05). CONCLUSION: The study shows that there is no difference in effectiveness with the agents used. All of them will provide a rapid and satisfactory pain relief in most of the patients on any of the days. There is, however, a statistically significant difference in the number of side-effects when comparing buprenorphine with ketorolac.
Poster 139 RED Th-Fri Exhibit Hall
THE CLINICAL EVALUATION OF THE COMPASSIONATE USE OF ORAL TRANSMUCOSAL FENTANYL CITRATE (OTFC) FOR THE TREATMENT OF BREAKTHROUGHCANCER PAIN. E29. m, L. Olson, P.F. Fine, T.H. Stanley*, Acute Pain Service, Dept of Anesthesiology, University of Utah, Salt Lake City, Utah, U.S.A.
Abs No 679 AIM OF VTION, We report on the initial results of an ongoing study to detamine whether OTFC canbesuccessfully used to control breakthrough cancer pain as compared to an oral morphine solution in an open randomized trial. METHODS: This research study involves 10 cancer patients who suffer from significant breakthrough cancer pain m-spite of maxhnal conventional pain therapy. Patients in the study continue current cancer and pain management therapies. OTFC (15-20 mcgkg) and oral morphine (25-75 mg) is used for the treatment of brealttbrough pain in an open, random&d trial (Table 1). Bach patient is given a diary to record pain medications, pain assessment and any adverse effects. ‘lhe patient assesses his/her pain using the Visual Analog Scale and O-10Numeric Scale four times a day throughout the study. In addition, pain is assessed 30 mhi before and 30 mitt after using OTFC or morphine for the treatment of bmakkougbpain. RESULTS: Two patients have completed the study to date. The results are summarixed in Fig. 1 and 2. The addition of both OTFC and oral morphine solution decreased overall pain experience as documented by daily VAS (Fig. 1). In addition, both OTFC and cual morphine were effective in providing analgesia for breakthrough pain. However, the onset of analgesia with OTFC was shorter than seen with the oral morphhie solution (Fig. 2). CONCLU~ Both OTFC and oral morphine solution provide analgesia for breaktlu~ugh cancer pain. However, OTFC offers the potential advantages of providing titratable analgesia with a more rapid onset time. Further data are necessary to identify OTFCs role in treatment of breakthrough cancer pain. TABLE 1. TREATMENT PROTOCOL JX=gwGrouDn baseliie 1 : 4 2 7
baseline morphine K: morphine baseline baseliie morphme OTFC Z%Y
BASBLINE -MGRPElM -GlK
l-
Ze
g ’
morphme morphine
=
’ BR&FAST
L&Ii
DMER
TIME OF DAY Figure 1
BEDTIME
r O-3
3-S
ONSET
OF
A DOUBLE-BLIND COMPARISON OF MULTIPLE DOSE REGIMEN OF KETOROLAC AND BUPRENORPHINE IN PATIENTS WITH CANCER PAIN. M. Sta uet*l and G. De Wasch*2 (SPON: P. Ewalenko), IInstitut Jules dussels, Belgium ; 2Ziekenhuis Henri Seruys, Oostende, Belgium. AIM OF THE INVESTIGATION: To compare the analgesic efficacy and adverse effects of IM ketorolac (10 mg and 30 mg) with those of buprenorphine (0.3 mg) when the drugs are administered for 3 days.
1
S-10 lo-15 15-3030-45 45-60 N3 REum ANALGESIA
Figure
(MINUTES) 2
Poster 140 RED Th-Fri Exhibit Hall Abs No
680
METHODS: The trial is a double-blind, multidose, double observer, parallel study in three grm 40 patients experiencing moderate to severe pain. Informed consent was given in all cases. The study medications were administered as required by the patient by a nurse not involved in the evaluation of the results. Patients were asked to rate pain severity and pain relief on a verbal standard scale. Patterns of usage, duration of efficacy, acceptance, side-effects, global evaluation were also investigated at preselected times. RESULTS: At the end of the trial, the patients' overall opinion was fair to excellent in 92me cases with buprenorphine and ketorolac 10 mg and in 83% with ketorolac 30 mg (NS). The investigator's global evaluation was 94% for buprenorphine and 89% for both doses of ketorolac (NS). On day 1, complete pain relief was seen in 22% of the subjects with buprenorphine, in 24% with ketorolac 10 mg and in 22% with ketorolac 30 mg (NS). Comparable relative frequencies were observed for day 2 and day 3. When considering the scores for moderate or complete relief, 80% of the patients were classified in one of these categories. Side-effects were seen more often with buprenorphine (17% of the cases) than with ketorolac 30 mg (3%) or ketorolac 10 mg (0%) (p C 0.05). CONCLUSION: The study shows that there is no difference in effectiveness with the agents used. All of them will provide a rapid and satisfactory pain relief in most of the patients on any of the days. There is, however, a statistically significant difference in the number of side-effects when comparing buprenorphine with ketorolac.