The Clinical Usefulness of Tramadol

Tramadol is an opioid analgesic which is prescribed worldwide. Hydrochloride oral and injectable formulations have been approved for cancer pain and postoperative pain (injection only) in Japan. In addition, tablets combining tramadol with acetaminophen have been administrated for non-cancer pain an...

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Published inTHE JOURNAL OF JAPAN SOCIETY FOR CLINICAL ANESTHESIA Vol. 33; no. 1; pp. 041 - 050
Main Author KAWAI, Koji
Format Journal Article
LanguageJapanese
Published THE JAPAN SOCIETY FOR CLINICAL ANESTHESIA 2013
Subjects
Chronic pain
Musculoskeletal pain
Non-cancer pain
Pain management
Tramadol
Online AccessGet full text
ISSN0285-4945
1349-9149
DOI10.2199/jjsca.33.041

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Abstract Tramadol is an opioid analgesic which is prescribed worldwide. Hydrochloride oral and injectable formulations have been approved for cancer pain and postoperative pain (injection only) in Japan. In addition, tablets combining tramadol with acetaminophen have been administrated for non-cancer pain and post-tooth-extraction pain. Tramadol acts as a μ-opioid receptor agonist and inhibits the reuptake of serotonin and norepinephrine. Regarding the management of cancer pain, it is placed on the second step of the World Health Organization analgesic ladder. Tramadol is gradually coming into use as a relatively safe and less addictive drug among opioid analgesics for both cancer and non-cancer pain.
AbstractList Tramadol is an opioid analgesic which is prescribed worldwide. Hydrochloride oral and injectable formulations have been approved for cancer pain and postoperative pain (injection only) in Japan. In addition, tablets combining tramadol with acetaminophen have been administrated for non-cancer pain and post-tooth-extraction pain. Tramadol acts as a μ-opioid receptor agonist and inhibits the reuptake of serotonin and norepinephrine. Regarding the management of cancer pain, it is placed on the second step of the World Health Organization analgesic ladder. Tramadol is gradually coming into use as a relatively safe and less addictive drug among opioid analgesics for both cancer and non-cancer pain.
Author KAWAI, Koji
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References 7) Raffa RB, Friderichs E, Reimann W, et al.: Complementary and synergistic antinociceptive interaction between the enantiomers of tramadol. J Pharmacol Exp Ther 267: 331-340, 1993
38) 新谷悟，小林健，久保田英朗ほか：抜歯後疼痛に対するJNS013（トラマドール塩酸塩/アセトアミノフェン配合錠）の臨床評価：各配合成分の単独投与との二重盲検比較試験．日口外誌 58：110-122，2012
40) Mildh LH, Leino KA, Kirvelä OA: Effects of tramadol and meperidine on respiration, plasma catecholamine concentrations, and hemodynamics. J Clin Anesth 11: 310-316, 1999
18) Cicero TJ, Inciardi JA, Adams EH, et al.: Rates of abuse of tramadol remain unchanged with the introduction of new branded and generic products: results of an abuse monitoring system, 1994-2004. Pharmacoepidemiol Drug Saf 14: 851-859, 2005
33) Lee EY, Lee EB, Park BJ, et al.: Tramadol 37.5-mg/acetaminophen 325-mg combination tablets added to regular therapy for rheumatoid arthritis pain: a 1-week, randomized, double-blind, placebo-controlled trial. Clin Ther 28: 2052-2060, 2006
44) Reeves RR, Burke RS: Tramadol: basic pharmacology and emerging concepts. Drugs Today (Barc) 44: 827-836, 2008
4) Nakamura M, Nishiwaki Y, Ushida T, et al.: Prevalence and characteristics of chronic musculoskeletal pain in Japan. J Orthop Sci 16: 424-432, 2011
29) Ruoff GE, Rosenthal N, Jordan D, et al.: Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study. Clin Ther 25: 1123-1141, 2003
17) Cicero TJ, Adams EH, Geller A, et al.: A postmarketing surveillance program to monitor Ultram (tramadol hydrochloride) abuse in the United States. Drug Alcohol Depend 57: 7-22, 1999
22) Twycross RG, Wilcock A, Charlesworth S, et al.: Palliative Care Formulary, 2nd ed. Radcliffe Publishing Ltd., Mylton Keynes, 2002, 168-173
49) Walter RB, Milano F, Brasky TM, et al.: Long-term use of acetaminophen, aspirin, and other nonsteroidal anti-inflammatory drugs and risk of hematologic malignancies: results from the prospective Vitamins and Lifestyle (VITAL) study. J Clin Oncol 29: 2424-2431, 2011
48) トラムセット®配合錠インタビューフォーム
9) Reimann W, Hennies HH: Inhibition of spinal noradrenaline uptake in rats by the centrally acting analgesic tramadol. Biochem Pharmacol 47: 2289-2293, 1994
41) Kitada M: Genetic polymorphism of cytochrome P450 enzymes in Asian populations: focus on CYP2D6. Int J Clin Pharmacol Res 23: 31-35, 2003
32) Silverfield JC, Kamin M, Wu SC, et al.: Tramadol/acetaminophen combination tablets for the treatment of osteoarthritis flare pain: a multicenter, outpatient, randomized, double-blind, placebo-controlled, parallel-group, add-on study. Clin Ther 24: 282-297, 2002
10) Dworkin RH, O'Connor AB, Backonja M, et al.: Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 132: 237-251, 2007
14) 世界保健機関編，武田文和訳：がんの痛みからの解放─WHO方式がん疼痛治療法─　付：オピオイド鎮痛薬の規制ガイド（第2版）．金原出版，東京，1996
36) Bennett RM, Kamin M, Karim R, et al.: Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med 114: 537-545, 2003
13) Lee CR, McTavish D, Sorkin EM, et al.: Tramadol. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in acute and chronic pain states. Drugs 46: 313-340, 1993
23) Ko SH, Kwon HS, Yu JM, et al.: Comparison of the efficacy and safety of tramadol/acetaminophen combination therapy and gabapentin in the treatment of painful diabetic neuropathy. Diabet Med 27: 1033-1040, 2010
31) Emkey R, Rosenthal N, Wu SC, et al.: Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial. J Rheumatol 31: 150-156, 2004
12) Ide S, Minami M, Ishihara K, et al.: Mu opioid receptor-dependent and independent components in effects of tramadol. Neuropharmacology 51: 651-658, 2006
21) Dhillon S: Tramadol/paracetamol fixed-dose combination: a review of its use in the management of moderate to severe pain. Clin Drug Investig 30: 711-738, 2010
19) Cicero TJ, Ellis MS, Paradis A, et al.: Role of key informants and direct patient interviews in epidemiological studies of substance abuse. Pharmacoepidemiol Drug Saf 20: 308-312, 2011
6) Bamigbade TA, Davidson C, Langford RM, et al.: Actions of tramadol, its enantiomers and principal metabolite, O-desmethyltramadol, on serotonin (5-HT) efflux and uptake in the rat dorsal raphe nucleus. Br J Anaesth 79: 352-356, 1997
11) 住谷昌彦，山田芳嗣：QOLを考えた神経障害性疼痛の治療におけるプレガバリンとトラマドールの位置づけ．臨麻 36（増）：389-398，2012
45) Boyer EW, Shannon M : The serotonin syndrome. N Engl J Med 352: 1112-1120, 2005
24) Yalcin I, Aksu F, Bodard S, et al.: Antidepressant-like effect of tramadol in the unpredictable chronic mild stress procedure: possible involvement of the noradrenergic system. Behav Pharmacol 18: 623-631, 2007
35) Freeman R, Raskin P, Hewitt DJ, et al.: Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Curr Med Res Opin 23: 147-161, 2007
20) Mullican WS, Lacy JR: Tramadol/acetaminophen combination tablets and codeine/acetaminophen combination capsules for the management of chronic pain: a comparative trial. Clini Ther 23: 1429-1445, 2001
46) Bloor M, Paech MJ, Kaye R: Tramadol in pregnancy and lactation. Int J Obstet Anesth 21: 163-167, 2012
8) Grond S, Sablotzki A: Clinical pharmacology of tramadol. Clin Pharmacokinet 43: 879-923, 2004
15) 伊達久：非がん性慢性疼痛における新たなオピオイド治療薬：トラマドール塩酸塩/アセトアミノフェン配合錠（トラムセット配合錠）．ペインクリニック 32：1087-1091，2011
43) 北原雅樹：塩酸トラマドール．ペインクリニック 31：1221-1223，2010
34) 井上靖雄，西村暁良，田熊清貴ほか：慢性疼痛に対するトラマドール塩酸塩/アセトアミノフェン配合剤の長期（52週間）投与試験．関節外科 31：88-97，2012
1) Cousins MJ, Lynch ME: The Declaration Montreal: access to pain management is a fundamental human right. Pain 152: 2673-2674, 2011
28) 松下隆，矢吹省司，牛田亨宏ほか：変形性膝関節症または腰痛症に伴う慢性疼痛を有する患者に対するトラマドール塩酸塩/アセトアミノフェン配合錠の第III相臨床試験─プラセボを対照としたランダム化治療中止二重盲検群間比較試験─．臨整外 46：825-835，2011
2) 日本ペインクリニック学会 非がん性慢性［疼］痛に対するオピオイド鎮痛薬処方ガイドライン作成ワーキンググループ編：日本ペインクリニック学会 非がん性慢性［疼］痛に対するオピオイド鎮痛薬処方ガイドライン．真興交易医書出版部，東京，2012
30) Peloso PM, Fortin L, Beaulieu A, et al.: Analgesic efficacy and safety of tramadol/acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. J Rheumatol 31: 2454-2463, 2004
39) トラムセット®配合錠 添付文書
27) Perrot S, Krause D, Crozes P, et al.: Efficacy and tolerability of paracetamol/tramadol (325 mg/37.5 mg) combination treatment compared with tramadol (50 mg) monotherapy in patients with subacute low back pain: a multicenter, randomized, double-blind, parallel-group, 10-day treatment study. Clin Ther 28: 1592-1606, 2006
37) トラマール® 添付文書
47) Senay EC, Adams EH, Geller A, et al.: Physical dependence on Ultram (tramadol hydrochloride) : both opioid-like and atypical withdrawal symptoms occur. Drug Alcohol Depend 69: 233-241, 2003
26) Tallarida RJ, Raffa RB: Testing for synergism over a range of fixed ratio drug combinations: replacing the isobologram. Life Sci 58: 23-28, 1996
5) 齊藤洋司，小川節郎，眞下節ほか：慢性疼痛に対する薬物治療を中心とした治療実態調査─日本，米国，ドイツの比較─．Pharma Medica 28：137-148，2010
25) Tholen K, Hoffmann F: High use of tramadol in Germany: an analysis of statutory health insurance data. Pharmacoepidemiol Drug Saf 21: 1013-1021, 2012
42) Steijns LS, Van Der Weide J: Ultrarapid drug metabolism: PCR-based detection of CYP2D6 gene duplication. Clin Chem 44: 914-917, 1998
3) 松平浩，山田浩司，竹下克志ほか：日本における慢性疼痛の実態─Pain Associated Cross-sectional Epidemiological（PACE）survey 2009. JP─．ペインクリニック 32：1345-1356，2011
16) Adams EH, Breiner S, Cicelo TJ, et al.: A comparison of the abuse liability of tramadol, NSAIDs, and hydrocodone in patients with chronic pain. J Pain Symptom Manage 31: 465-476, 2006
References_xml – reference: 23) Ko SH, Kwon HS, Yu JM, et al.: Comparison of the efficacy and safety of tramadol/acetaminophen combination therapy and gabapentin in the treatment of painful diabetic neuropathy. Diabet Med 27: 1033-1040, 2010
– reference: 31) Emkey R, Rosenthal N, Wu SC, et al.: Efficacy and safety of tramadol/acetaminophen tablets (Ultracet) as add-on therapy for osteoarthritis pain in subjects receiving a COX-2 nonsteroidal antiinflammatory drug: a multicenter, randomized, double-blind, placebo-controlled trial. J Rheumatol 31: 150-156, 2004
– reference: 37) トラマール® 添付文書
– reference: 11) 住谷昌彦，山田芳嗣：QOLを考えた神経障害性疼痛の治療におけるプレガバリンとトラマドールの位置づけ．臨麻 36（増）：389-398，2012
– reference: 17) Cicero TJ, Adams EH, Geller A, et al.: A postmarketing surveillance program to monitor Ultram (tramadol hydrochloride) abuse in the United States. Drug Alcohol Depend 57: 7-22, 1999
– reference: 18) Cicero TJ, Inciardi JA, Adams EH, et al.: Rates of abuse of tramadol remain unchanged with the introduction of new branded and generic products: results of an abuse monitoring system, 1994-2004. Pharmacoepidemiol Drug Saf 14: 851-859, 2005
– reference: 2) 日本ペインクリニック学会 非がん性慢性［疼］痛に対するオピオイド鎮痛薬処方ガイドライン作成ワーキンググループ編：日本ペインクリニック学会 非がん性慢性［疼］痛に対するオピオイド鎮痛薬処方ガイドライン．真興交易医書出版部，東京，2012
– reference: 40) Mildh LH, Leino KA, Kirvelä OA: Effects of tramadol and meperidine on respiration, plasma catecholamine concentrations, and hemodynamics. J Clin Anesth 11: 310-316, 1999
– reference: 47) Senay EC, Adams EH, Geller A, et al.: Physical dependence on Ultram (tramadol hydrochloride) : both opioid-like and atypical withdrawal symptoms occur. Drug Alcohol Depend 69: 233-241, 2003
– reference: 19) Cicero TJ, Ellis MS, Paradis A, et al.: Role of key informants and direct patient interviews in epidemiological studies of substance abuse. Pharmacoepidemiol Drug Saf 20: 308-312, 2011
– reference: 7) Raffa RB, Friderichs E, Reimann W, et al.: Complementary and synergistic antinociceptive interaction between the enantiomers of tramadol. J Pharmacol Exp Ther 267: 331-340, 1993
– reference: 34) 井上靖雄，西村暁良，田熊清貴ほか：慢性疼痛に対するトラマドール塩酸塩/アセトアミノフェン配合剤の長期（52週間）投与試験．関節外科 31：88-97，2012
– reference: 49) Walter RB, Milano F, Brasky TM, et al.: Long-term use of acetaminophen, aspirin, and other nonsteroidal anti-inflammatory drugs and risk of hematologic malignancies: results from the prospective Vitamins and Lifestyle (VITAL) study. J Clin Oncol 29: 2424-2431, 2011
– reference: 20) Mullican WS, Lacy JR: Tramadol/acetaminophen combination tablets and codeine/acetaminophen combination capsules for the management of chronic pain: a comparative trial. Clini Ther 23: 1429-1445, 2001
– reference: 4) Nakamura M, Nishiwaki Y, Ushida T, et al.: Prevalence and characteristics of chronic musculoskeletal pain in Japan. J Orthop Sci 16: 424-432, 2011
– reference: 14) 世界保健機関編，武田文和訳：がんの痛みからの解放─WHO方式がん疼痛治療法─　付：オピオイド鎮痛薬の規制ガイド（第2版）．金原出版，東京，1996
– reference: 39) トラムセット®配合錠 添付文書
– reference: 38) 新谷悟，小林健，久保田英朗ほか：抜歯後疼痛に対するJNS013（トラマドール塩酸塩/アセトアミノフェン配合錠）の臨床評価：各配合成分の単独投与との二重盲検比較試験．日口外誌 58：110-122，2012
– reference: 27) Perrot S, Krause D, Crozes P, et al.: Efficacy and tolerability of paracetamol/tramadol (325 mg/37.5 mg) combination treatment compared with tramadol (50 mg) monotherapy in patients with subacute low back pain: a multicenter, randomized, double-blind, parallel-group, 10-day treatment study. Clin Ther 28: 1592-1606, 2006
– reference: 46) Bloor M, Paech MJ, Kaye R: Tramadol in pregnancy and lactation. Int J Obstet Anesth 21: 163-167, 2012
– reference: 30) Peloso PM, Fortin L, Beaulieu A, et al.: Analgesic efficacy and safety of tramadol/acetaminophen combination tablets (Ultracet) in treatment of chronic low back pain: a multicenter, outpatient, randomized, double blind, placebo controlled trial. J Rheumatol 31: 2454-2463, 2004
– reference: 21) Dhillon S: Tramadol/paracetamol fixed-dose combination: a review of its use in the management of moderate to severe pain. Clin Drug Investig 30: 711-738, 2010
– reference: 9) Reimann W, Hennies HH: Inhibition of spinal noradrenaline uptake in rats by the centrally acting analgesic tramadol. Biochem Pharmacol 47: 2289-2293, 1994
– reference: 13) Lee CR, McTavish D, Sorkin EM, et al.: Tramadol. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in acute and chronic pain states. Drugs 46: 313-340, 1993
– reference: 10) Dworkin RH, O'Connor AB, Backonja M, et al.: Pharmacologic management of neuropathic pain: evidence-based recommendations. Pain 132: 237-251, 2007
– reference: 24) Yalcin I, Aksu F, Bodard S, et al.: Antidepressant-like effect of tramadol in the unpredictable chronic mild stress procedure: possible involvement of the noradrenergic system. Behav Pharmacol 18: 623-631, 2007
– reference: 48) トラムセット®配合錠インタビューフォーム
– reference: 32) Silverfield JC, Kamin M, Wu SC, et al.: Tramadol/acetaminophen combination tablets for the treatment of osteoarthritis flare pain: a multicenter, outpatient, randomized, double-blind, placebo-controlled, parallel-group, add-on study. Clin Ther 24: 282-297, 2002
– reference: 43) 北原雅樹：塩酸トラマドール．ペインクリニック 31：1221-1223，2010
– reference: 45) Boyer EW, Shannon M : The serotonin syndrome. N Engl J Med 352: 1112-1120, 2005
– reference: 12) Ide S, Minami M, Ishihara K, et al.: Mu opioid receptor-dependent and independent components in effects of tramadol. Neuropharmacology 51: 651-658, 2006
– reference: 22) Twycross RG, Wilcock A, Charlesworth S, et al.: Palliative Care Formulary, 2nd ed. Radcliffe Publishing Ltd., Mylton Keynes, 2002, 168-173
– reference: 1) Cousins MJ, Lynch ME: The Declaration Montreal: access to pain management is a fundamental human right. Pain 152: 2673-2674, 2011
– reference: 5) 齊藤洋司，小川節郎，眞下節ほか：慢性疼痛に対する薬物治療を中心とした治療実態調査─日本，米国，ドイツの比較─．Pharma Medica 28：137-148，2010
– reference: 6) Bamigbade TA, Davidson C, Langford RM, et al.: Actions of tramadol, its enantiomers and principal metabolite, O-desmethyltramadol, on serotonin (5-HT) efflux and uptake in the rat dorsal raphe nucleus. Br J Anaesth 79: 352-356, 1997
– reference: 26) Tallarida RJ, Raffa RB: Testing for synergism over a range of fixed ratio drug combinations: replacing the isobologram. Life Sci 58: 23-28, 1996
– reference: 42) Steijns LS, Van Der Weide J: Ultrarapid drug metabolism: PCR-based detection of CYP2D6 gene duplication. Clin Chem 44: 914-917, 1998
– reference: 15) 伊達久：非がん性慢性疼痛における新たなオピオイド治療薬：トラマドール塩酸塩/アセトアミノフェン配合錠（トラムセット配合錠）．ペインクリニック 32：1087-1091，2011
– reference: 35) Freeman R, Raskin P, Hewitt DJ, et al.: Randomized study of tramadol/acetaminophen versus placebo in painful diabetic peripheral neuropathy. Curr Med Res Opin 23: 147-161, 2007
– reference: 36) Bennett RM, Kamin M, Karim R, et al.: Tramadol and acetaminophen combination tablets in the treatment of fibromyalgia pain: a double-blind, randomized, placebo-controlled study. Am J Med 114: 537-545, 2003
– reference: 8) Grond S, Sablotzki A: Clinical pharmacology of tramadol. Clin Pharmacokinet 43: 879-923, 2004
– reference: 3) 松平浩，山田浩司，竹下克志ほか：日本における慢性疼痛の実態─Pain Associated Cross-sectional Epidemiological（PACE）survey 2009. JP─．ペインクリニック 32：1345-1356，2011
– reference: 28) 松下隆，矢吹省司，牛田亨宏ほか：変形性膝関節症または腰痛症に伴う慢性疼痛を有する患者に対するトラマドール塩酸塩/アセトアミノフェン配合錠の第III相臨床試験─プラセボを対照としたランダム化治療中止二重盲検群間比較試験─．臨整外 46：825-835，2011
– reference: 25) Tholen K, Hoffmann F: High use of tramadol in Germany: an analysis of statutory health insurance data. Pharmacoepidemiol Drug Saf 21: 1013-1021, 2012
– reference: 33) Lee EY, Lee EB, Park BJ, et al.: Tramadol 37.5-mg/acetaminophen 325-mg combination tablets added to regular therapy for rheumatoid arthritis pain: a 1-week, randomized, double-blind, placebo-controlled trial. Clin Ther 28: 2052-2060, 2006
– reference: 44) Reeves RR, Burke RS: Tramadol: basic pharmacology and emerging concepts. Drugs Today (Barc) 44: 827-836, 2008
– reference: 29) Ruoff GE, Rosenthal N, Jordan D, et al.: Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study. Clin Ther 25: 1123-1141, 2003
– reference: 41) Kitada M: Genetic polymorphism of cytochrome P450 enzymes in Asian populations: focus on CYP2D6. Int J Clin Pharmacol Res 23: 31-35, 2003
– reference: 16) Adams EH, Breiner S, Cicelo TJ, et al.: A comparison of the abuse liability of tramadol, NSAIDs, and hydrocodone in patients with chronic pain. J Pain Symptom Manage 31: 465-476, 2006
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Snippet Tramadol is an opioid analgesic which is prescribed worldwide. Hydrochloride oral and injectable formulations have been approved for cancer pain and...
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SubjectTerms Chronic pain
Musculoskeletal pain
Non-cancer pain
Pain management
Tramadol
Title The Clinical Usefulness of Tramadol
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