A comparison of change in the 0-10 numeric rating scale to a pain relief scale and global medication performance scale in a short-term clinical trial of breakthrough pain intensity.
BACKGROUND
Pain intensity is commonly reported using a 0-10 Numeric Rating Scale in pain clinical trials. Analysis of the change on the Pain Intensity Numerical Rating Scale as a proportion has most consistently correlated with clinically important differences reported on the patient's global impression of change. The correlation of data from patients with breakthrough pain with a Pain Relief Scale and a different global outcome measures will extend our understanding of these measures.


METHODS
Data were obtained from the open titration phase of a multiple crossover, randomized, double-blind clinical trial comparing oral transmucosal fentanyl citrate with immediate-release oral morphine sulfate for the treatment of cancer-related breakthrough pain. Raw and percentage changes in the pain intensity scores from 1,307 episodes of pain in 134 oral transmucosal fentanyl citrate-naïve patients were correlated with the clinically relevant secondary outcomes of Pain Relief Verbal Response Scale and the global medication performance scale. The changes in raw and percentage change were assessed over time and compared with the ordinal Pain Relief Verbal Response Scale and Global Medication Performance Scale.


RESULTS
The P value of the interaction between the raw pain intensity difference was significant (P = 0.034) for four 15-min time periods but not for the percentage pain intensity difference score (P = 0.26). We found similar results in comparison with the ordinal Pain Relief Verbal Response Scale (P = 0.0048 and P = 0.36 respectively) and global medication performance categories (P = 0.048 and P = 0.45, respectively).


CONCLUSIONS
The change in pain intensity in breakthrough pain was more consistent over time and when compared with both the Pain Relief Verbal Response Scale and the Global Medication Performance Scale when the percentage change is used rather than raw pain intensity difference.
Farrar
John T
JT
Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA. jfarrar@mail.med.upenn.edu
Polomano
Rosemary C
RC
Berlin
Jesse A
JA
Strom
Brian L
BL
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D015331:Cohort Studies; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005283:Fentanyl / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009020:Morphine / Q000008:administration & dosage*; D010146:Pain / Q000175:diagnosis* / Q000188:drug therapy*; D010147:Pain Measurement / Q000379:methods / Q000592:standards*; D013997:Time Factors; D055815:Young Adult
D009020:Morphine; D005283:Fentanyl
Reg Anesth Pain Med. 2008 Jul-Aug;33(4):320-5
18675742
Anesthesiology. 2005 May;102(5):1014-22
15851890
Ann N Y Acad Sci. 1960 Mar 30;86:28-37
14414321
Pain. 2003 Sep;105(1-2):151-7
14499431
Eur J Pain. 2008 Feb;12(2):203-13
17631400
Ann Acad Med Singap. 1994 Mar;23(2):129-38
8080219
Pain. 2001 Nov;94(2):149-158
11690728
Anesthesiology. 2005 Jul;103(1):156-60
15983468
J Rehabil Med. 2001 Jan;33(1):47-8
11480471
Pain. 1996 Aug;66(2-3):229-37
8880845
Br J Anaesth. 2008 Jul;101(1):17-24
18487245
Pain. 2008 Jul 15;137(2):276-285
17937976
J Pain Symptom Manage. 2006 Apr;31(4):369-77
16632085
J Pain. 2005 Nov;6(11):741-6
16275598
Curr Med Res Opin. 2008 Nov;24(11):3185-96
18851776
BMC Med Res Methodol. 2001;1:6
11459516
Clin J Pain. 2006 Jan;22(1 Suppl):S9-13
16344610
Eur J Pain. 2005 Aug;9(4):389-93
15979019
Anesthesiology. 2008 Aug;109(2):289-96
18648238
J Pain. 2008 Feb;9(2):105-21
18055266
Curr Pain Headache Rep. 2006 Jun;10(3):179-84
18778571
J Pain. 2005 Jun;6(6):400-6
15943962
Pain. 2006 Sep;124(1-2):158-66
16716517
Pain. 1993 Apr;53(1):3-16
8316386
J Pain Symptom Manage. 2004 Sep;28(3):225-32
15336334
Ann Med. 2000 Jul;32(5):305-16
10949061
Curr Opin Anaesthesiol. 1998 Oct;11(5):533-7
17013270
Cancer. 1987 Sep 1;60(5):1151-8
3300951
Neurology. 2008 Jun 10;70(24):2305-13
18541884
J Rheumatol. 1993 Mar;20(3):561-5
8478874
Acta Anaesthesiol Scand Suppl. 1982;74:25-9
6953733
Pain. 2001 Mar;91(1-2):123-30
11240084
BMC Neurol. 2008 Aug 01;8:29
18673529
Qual Life Res. 2008 Dec;17(10):1303-13
18953670
Arthritis Res Ther. 2008;10(2):R39
18384679
Anesth Analg. 1999 Sep;89(3):732-8
10475315
Surg Clin North Am. 1999 Apr;79(2):231-52
10352653
Clin J Pain. 2004 Sep-Oct;20(5):309-18
15322437