Randomized, double-blind, placebo-controlled study to assess the efficacy and toxicity of subcutaneous ketamine in the management of cancer pain

Journal of Clinical Oncology

Volumn 30, Issue 29, 2012, Pages 3611-3617

  Hardy, Janet ^a   Quinn, Stephen ^b   Fazekas, Belinda ^b   Plummer, John ^c   Eckermann, Simon ^d   Agar, Meera ^e   Spruyt, Odette ^f   Rowett, Debra ^b   Currow, David C ^b  

^a MATER HOSPITAL   (Australia)

^b FLINDERS UNIVERSITY   (Australia)

^c FLINDERS MEDICAL CENTRE   (Australia)

^d UNIVERSITY OF WOLLONGONG   (Australia)

^e SOUTH WESTERN SYDNEY LOCAL HEALTH DISTRICT   (Australia)

^f PETER MACCALLUM CANCER CENTRE   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

HALOPERIDOL; KETAMINE; MIDAZOLAM; MORPHINE; PLACEBO;

ADJUVANT THERAPY; ADULT; ANALGESIA; APPLICATION SITE IRRITATION; ARTICLE; BRADYCARDIA; BRAIN TOXICITY; CANCER PAIN; COGNITIVE DEFECT; CONFUSION; CONSTIPATION; CONTROLLED STUDY; DISEASE SEVERITY; DIZZINESS; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; FEMALE; GENERAL CONDITION DETERIORATION; HEART ARREST; HEART ARRHYTHMIA; HUMAN; HYPERTENSION; HYPOXIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA; NEUROPATHIC PAIN; NOCICEPTIVE PAIN; OUTCOME ASSESSMENT; PAIN ASSESSMENT; PHASE 3 CLINICAL TRIAL; PREDICTIVE VALUE; PRIORITY JOURNAL; PSYCHOTOXICITY; RANDOMIZED CONTROLLED TRIAL; SOMNOLENCE; TREATMENT DURATION; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VOMITING;

AGE FACTORS; AGED; AGED, 80 AND OVER; ANALGESICS; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INJECTIONS, SUBCUTANEOUS; KETAMINE; LOGISTIC MODELS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; NEOPLASMS; PAIN MEASUREMENT; PAIN, INTRACTABLE; PALLIATIVE CARE; PROGNOSIS; PROPORTIONAL HAZARDS MODELS; QUEENSLAND; REFERENCE VALUES; RISK ASSESSMENT; SEVERITY OF ILLNESS INDEX; SEX FACTORS; TREATMENT OUTCOME;

EID: 84864391701     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2012.42.1081     Document Type: Article

References (26)

1. Foley KM: How well is cancer pain treated? Palliat Med 25:398-401, 2011
2. Bell RF, Eccleston C, Kalso E: Ketamine as adjuvant to opioids for cancer pain: A qualitative systematic review. J Pain Symptom Manage 26:867-875, 2003 (Pubitemid 37101234)
3. Jackson K, Ashby M, Howell D, et al: The effectiveness and adverse event profile of "burst" ketamine in refractory cancer pain: The VCOG PM 1-00 study. J Palliat Care 26:176-183, 2010
4. Kerr C, Holahan T, Milch R: The use of ketamine in severe cases of refractory pain syndromes in the palliative care setting: A case series. J Palliat Med 14:1074-1077, 2011
5. Quibell R, Prommer EE, Mihalyo M, et al: Ketamine*. J Pain Symptom Manage 41:640-649, 2011
6. Middela S, Pearce I: Ketamine-induced vesicopathy: A literature review. Int J Clin Pract 65:27-30, 2011
7. McCaffrey N, Currow DC, Eckermann S: Measuring impacts of value to patients is crucial when evaluating palliative care. J Pain Symptom Manage 37:e7-e9, 2009
8. Currow DC, Shelby-James TM, Agar M, et al: Planning phase III multi-site clinical trials in palliative care: The role of consecutive cohort audits to identify potential participant populations. Support Care Cancer 18:1571-1579, 2010
9. Currow DC, Spruyt O, Hardy J: Defining refractory pain in cancer for clinicians and researchers. J Palliat Medicine 15:5-6, 2012
10. Cleeland C: Measurement of pain by subjective report, in Chapman CR (author), Loeser JD (ed): Advances in Pain Research and Therapy, Vol 12: Issues in Pain Measurement. New York, NY, Raven Press, 1989, pp 391-403
11. Sweetman SC (ed): Martindale: The Complete Drug Reference (ed 37). London, United Kingdom, Pharmaceutical Press, 2011, pp 1943-1944
12. Bennett M: The LANSS pain scale: The Leeds Assessment of Neuropathic Symptoms and Signs. Pain 92:147-157, 2001
13. Farrar JT, Young JP Jr, LaMoreaux L, et al: Clinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scale. Pain 94:149-158, 2001 (Pubitemid 33016608)
14. Cancer Therapy Evaluation Program: Common Terminology Criteria for Adverse Events, V3.0. http://ctep.cancer.gov/protocolDevelopment/electronic- applications/docs/ctcaev3.pdf
15. Bremner JD, Krystal JH, Putnam FW, et al: Measurement of dissociative states with the Clinician-Administered Dissociative States Scale (CADSS). J Trauma Stress 11:125-136, 1998 (Pubitemid 28097797)
16. Bell R, Eccleston C, Kalso E: Ketamine as an adjuvant to opioids for cancer pain. Cochrane Database Syst Rev 1:CD003351, 2003
17. McQuay HJ, Moore RA: Antidepressants and chronic pain. BMJ 314:763-764, 1997 (Pubitemid 27117040)
18. Turner JA, Deyo RA, Loeser JD, et al: The importance of placebo effects in pain treatment and research. JAMA 271:1609-1614, 1994 (Pubitemid 24155623)
19. Irizarry MC, Webb DJ, Ali Z, et al: Predictors of placebo response in pooled lamotrigine neuropathic pain clinical trials. Clin J Pain 25:469-476, 2009
20. Farrar JT: Advances in clinical research methodology for pain clinical trials. Nature Med 16:1284-1293, 2010
21. de la Cruz M, Hui D, Parsons HA, et al: Placebo and nocebo effects in randomized double-blind clinical trials of agents for the therapy of fatigue in patients with advanced cancer. Cancer 116:766-774, 2010
22. Currow DC, Stevenson JP, Abernethy AP, et al: Prescribing in palliative care as death approaches. J Am Geriatr Soc 55:590-595, 2007 (Pubitemid 46496589)
23. Krystal JH, Karper LP, Seibyl JP, et al: Sub-anesthetic effects of the noncompetitive NMDA antagonist, ketamine, in humans. Arch Gen Psychiatry 51:199-214, 1999
24. Sterne JA, White IR, Carlin JB, et al: Multiple imputation for missing data in epidemiological and clinical research: Potential and pitfalls. BMJ 338:b2393, 2009
25. Aoun SM, Kristjanson LJ: Evidence in palliative care research: How should it be gathered? Med J Aust 183:264-266, 2005 (Pubitemid 41245949)
26. Reeves BC, van Binsbergen J, van Weel C: Systematic reviews incorporating evidence from nonrandomized study designs: Reasons for caution when estimating health effects. Eur J Clin Nutr 59:S155-S161, 2005 (Pubitemid 41195197)