Clinical trial NCT01731873 - References

Pain — Patient Controlled Analgesia Pharmacogenetic Study

Citation(s)

•   Ameyaw MM, Regateiro F, Li T, Liu X, Tariq M, Mobarek A, Thornton N, Folayan GO, Githang'a J, Indalo A, Ofori-Adjei D, Price-Evans DA, McLeod HL
  MDR1 pharmacogenetics: frequency of the C3435T mutation in exon 26 is significantly influenced by ethnicity. Pharmacogenetics. 2001 Apr;11(3):217-21.
•   Anderson BJ, Palmer GM
  Recent developments in the pharmacological management of pain in children. Curr Opin Anaesthesiol. 2006 Jun;19(3):285-92. Review.
•   Aubrun F, Monsel S, Langeron O, Coriat P, Riou B
  Postoperative titration of intravenous morphine. Eur J Anaesthesiol. 2001 Mar;18(3):159-65.
•   Baselt RC
  Disposition of Toxic drugs and Chemicals in Man. 430-33, 2002.
•   Beaulieu P, Cyrenne L, Mathews S, Villeneuve E, Vischoff D
  Patient-controlled analgesia after spinal fusion for idiopathic scoliosis. Int Orthop. 1996;20(5):295-9.
•   Benetton SA, Borges VM, Chang TK, McErlane KM
  Role of individual human cytochrome P450 enzymes in the in vitro metabolism of hydromorphone. Xenobiotica. 2004 Apr;34(4):335-44.
•   Benhamou D, Viel E, Berti M, Brodner G, De Andres J, Draisci G, Moreno-Azcoita M, Neugebauer EA, Schwenk W, Torres LM
  [PATHOS study on postoperative pain management in Europe: French data]. Ann Fr Anesth Reanim. 2008 Sep;27(9):664-78. doi: 10.1016/j.annfar.2008.07.092. Epub 2008 Sep 6. French.
•   Bisgaard T, Klarskov B, Rosenberg J, Kehlet H
  Characteristics and prediction of early pain after laparoscopic cholecystectomy. Pain. 2001 Feb 15;90(3):261-9.
•   Brennan F, Carr DB, Cousins M
  Pain management: a fundamental human right. Anesth Analg. 2007 Jul;105(1):205-21. Review.
•   Bringuier S, Dadure C, Raux O, Dubois A, Picot MC, Capdevila X
  The perioperative validity of the visual analog anxiety scale in children: a discriminant and useful instrument in routine clinical practice to optimize postoperative pain management. Anesth Analg. 2009 Sep;109(3):737-44. doi: 10.1213/ane.0b013e3181af00e4.
•   Bulloch B, Tenenbein M
  Validation of 2 pain scales for use in the pediatric emergency department. Pediatrics. 2002 Sep;110(3):e33.
•   Campa D, Gioia A, Tomei A, Poli P, Barale R
  Association of ABCB1/MDR1 and OPRM1 gene polymorphisms with morphine pain relief. Clin Pharmacol Ther. 2008 Apr;83(4):559-66. Epub 2007 Sep 26.
•   Chen E, Zeltzer LK, Craske MG, Katz ER
  Alteration of memory in the reduction of children's distress during repeated aversive medical procedures. J Consult Clin Psychol. 1999 Aug;67(4):481-90.
•   Coffman BL, Rios GR, King CD, Tephly TR
  Human UGT2B7 catalyzes morphine glucuronidation. Drug Metab Dispos. 1997 Jan;25(1):1-4.
•   Coller JK, Barratt DT, Dahlen K, Loennechen MH, Somogyi AA
  ABCB1 genetic variability and methadone dosage requirements in opioid-dependent individuals. Clin Pharmacol Ther. 2006 Dec;80(6):682-90.
•   Coulbault L, Beaussier M, Verstuyft C, Weickmans H, Dubert L, Trégouet D, Descot C, Parc Y, Lienhart A, Jaillon P, Becquemont L
  Environmental and genetic factors associated with morphine response in the postoperative period. Clin Pharmacol Ther. 2006 Apr;79(4):316-24.
•   D'Arcy Y
  Eyeing capnography to improve PCA safety. Nursing. 2007 Sep;37(9):18-9.
•   D'Arcy Y
  One opioid does not fit all. Nurse Pract. 2007 Nov;32(11):7-8.
•   D'Argenio D
  ADAPT 5 User's Guide: Pharmacokinetic/Pharmacodynamic Systems Analysis Software. Los Angeles: Biomedical Simulations Resource, 2009.
•   D'Argenio DZ, Schumitzky A, Wang X
  ADAPT 5 User's Guide: Pharmacokinetic/Pharmacodynamic Systems Analysis Software. Los Angeles: Biomedical Simulations Resource, 2009.
•   Dahan A, Aarts L, Smith TW
  Incidence, Reversal, and Prevention of Opioid-induced Respiratory Depression. Anesthesiology. 2010 Jan;112(1):226-38. doi: 10.1097/ALN.0b013e3181c38c25. Review.
•   Darbari DS, van Schaik RH, Capparelli EV, Rana S, McCarter R, van den Anker J
  UGT2B7 promoter variant -840G>A contributes to the variability in hepatic clearance of morphine in patients with sickle cell disease. Am J Hematol. 2008 Mar;83(3):200-2.
•   Diatchenko L, Nackley AG, Slade GD, Bhalang K, Belfer I, Max MB, Goldman D, Maixner W
  Catechol-O-methyltransferase gene polymorphisms are associated with multiple pain-evoking stimuli. Pain. 2006 Dec 5;125(3):216-24. Epub 2006 Jul 11.
•   Diatchenko L, Slade GD, Nackley AG, Bhalang K, Sigurdsson A, Belfer I, Goldman D, Xu K, Shabalina SA, Shagin D, Max MB, Makarov SS, Maixner W
  Genetic basis for individual variations in pain perception and the development of a chronic pain condition. Hum Mol Genet. 2005 Jan 1;14(1):135-43. Epub 2004 Nov 10.
•   Duedahl TH, Hansen EH
  A qualitative systematic review of morphine treatment in children with postoperative pain. Paediatr Anaesth. 2007 Aug;17(8):756-74. Review.
•   Duguay Y, Báár C, Skorpen F, Guillemette C
  A novel functional polymorphism in the uridine diphosphate-glucuronosyltransferase 2B7 promoter with significant impact on promoter activity. Clin Pharmacol Ther. 2004 Mar;75(3):223-33.
•   Feierman DE, Lasker JM
  Metabolism of fentanyl, a synthetic opioid analgesic, by human liver microsomes. Role of CYP3A4. Drug Metab Dispos. 1996 Sep;24(9):932-9.
•   Fletcher D, Fermanian C, Mardaye A, Aegerter P; Pain and Regional Anesthesia Committee of the French Anesthesia and Intensive Care Society (SFAR)
  A patient-based national survey on postoperative pain management in France reveals significant achievements and persistent challenges. Pain. 2008 Jul 15;137(2):441-51. doi: 10.1016/j.pain.2008.02.026. Epub 2008 Apr 15.
•   Gramke HF, de Rijke JM, van Kleef M, Raps F, Kessels AG, Peters ML, Sommer M, Marcus MA
  The prevalence of postoperative pain in a cross-sectional group of patients after day-case surgery in a university hospital. Clin J Pain. 2007 Jul-Aug;23(6):543-8.
•   Granot M, Ferber SG
  The roles of pain catastrophizing and anxiety in the prediction of postoperative pain intensity: a prospective study. Clin J Pain. 2005 Sep-Oct;21(5):439-45.
•   Grass JA
  Patient-controlled analgesia. Anesth Analg. 2005 Nov;101(5 Suppl):S44-61. Review.
•   Hamburg MA, Collins FS
  The path to personalized medicine. N Engl J Med. 2010 Jul 22;363(4):301-4. doi: 10.1056/NEJMp1006304. Epub 2010 Jun 15. Erratum in: N Engl J Med. 2010 Sep 9;363(11):1092.
•   Hanna MH, Elliott KM, Fung M
  Randomized, double-blind study of the analgesic efficacy of morphine-6-glucuronide versus morphine sulfate for postoperative pain in major surgery. Anesthesiology. 2005 Apr;102(4):815-21.
•   Hirota T, Ieiri I, Takane H, Sano H, Kawamoto K, Aono H, Yamasaki A, Takeuchi H, Masada M, Shimizu E, Higuchi S, Otsubo K
  Sequence variability and candidate gene analysis in two cancer patients with complex clinical outcomes during morphine therapy. Drug Metab Dispos. 2003 May;31(5):677-80.
•   Hodges LM, Markova SM, Chinn LW, Gow JM, Kroetz DL, Klein TE, Altman RB
  Very important pharmacogene summary: ABCB1 (MDR1, P-glycoprotein). Pharmacogenet Genomics. 2011 Mar;21(3):152-61. doi: 10.1097/FPC.0b013e3283385a1c.
•   Hutchison R
  A Comparison of a Fentanyl, morphine and hydromorphone Patient-controlled intravenous delivery for acute postoperative analgesia: A multicenter study of opioid-induced adverse reactions. Hospital Pharmacy 41:659-63, 2006.
•   Ikeda K, Ide S, Han W, Hayashida M, Uhl GR, Sora I
  How individual sensitivity to opiates can be predicted by gene analyses. Trends Pharmacol Sci. 2005 Jun;26(6):311-7. Review.
•   Joshi GP, Kehlet H, Rawal N; PROSPECT Working Group
  Evidence-based guidelines for postoperative pain management. Reg Anesth Pain Med. 2007 Mar-Apr;32(2):173.
•   Joshi GP, Ogunnaike BO
  Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North Am. 2005 Mar;23(1):21-36. Review.
•   Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC
  Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8.
•   Kain ZN, Sevarino FB, Rinder C, Pincus S, Alexander GM, Ivy M, Heninger G
  Preoperative anxiolysis and postoperative recovery in women undergoing abdominal hysterectomy. Anesthesiology. 2001 Mar;94(3):415-22.
•   Kehlet H, Jensen TS, Woolf CJ
  Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. Review.
•   Keogh E, Herdenfeldt M
  Gender, coping and the perception of pain. Pain. 2002 Jun;97(3):195-201.
•   Kim H, Ramsay E, Lee H, Wahl S, Dionne RA
  Genome-wide association study of acute post-surgical pain in humans. Pharmacogenomics. 2009 Feb;10(2):171-9. doi: 10.2217/14622416.10.2.171.
•   Kim RB, Leake BF, Choo EF, Dresser GK, Kubba SV, Schwarz UI, Taylor A, Xie HG, McKinsey J, Zhou S, Lan LB, Schuetz JD, Schuetz EG, Wilkinson GR
  Identification of functionally variant MDR1 alleles among European Americans and African Americans. Clin Pharmacol Ther. 2001 Aug;70(2):189-99.
•   Labroo RB, Paine MF, Thummel KE, Kharasch ED
  Fentanyl metabolism by human hepatic and intestinal cytochrome P450 3A4: implications for interindividual variability in disposition, efficacy, and drug interactions. Drug Metab Dispos. 1997 Sep;25(9):1072-80.
•   Maddox RR, Williams CK, Fields M
  Respiratory monitoring in patient-controlled analgesia. Am J Health Syst Pharm. 2004 Dec 15;61(24):2628, 2635.
•   Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S
  The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
•   Moons KG, Donders AR, Steyerberg EW, Harrell FE
  Penalized maximum likelihood estimation to directly adjust diagnostic and prognostic prediction models for overoptimism: a clinical example. J Clin Epidemiol. 2004 Dec;57(12):1262-70.
•   Moore JH, Williams SM
  New strategies for identifying gene-gene interactions in hypertension. Ann Med. 2002;34(2):88-95. Review.
•   Nackley AG, Tan KS, Fecho K, Flood P, Diatchenko L, Maixner W
  Catechol-O-methyltransferase inhibition increases pain sensitivity through activation of both beta2- and beta3-adrenergic receptors. Pain. 2007 Apr;128(3):199-208. Epub 2006 Nov 7.
•   Nelson KL, Yaster M, Kost-Byerly S, Monitto CL
  A national survey of American Pediatric Anesthesiologists: patient-controlled analgesia and other intravenous opioid therapies in pediatric acute pain management. Anesth Analg. 2010 Mar 1;110(3):754-60. doi: 10.1213/ANE.0b013e3181ca749c.
•   Overdyk M
  PCA presents serious risks. APSF Newsletter 20, 2005.
•   Paqueron X, Lumbroso A, Mergoni P, Aubrun F, Langeron O, Coriat P, Riou B
  Is morphine-induced sedation synonymous with analgesia during intravenous morphine titration? Br J Anaesth. 2002 Nov;89(5):697-701.
•   Park HJ, Shinn HK, Ryu SH, Lee HS, Park CS, Kang JH
  Genetic polymorphisms in the ABCB1 gene and the effects of fentanyl in Koreans. Clin Pharmacol Ther. 2007 Apr;81(4):539-46. Epub 2006 Dec 27.
•   Park MY, Hastie T
  Penalized logistic regression for detecting gene interactions. Biostatistics. 2008 Jan;9(1):30-50. Epub 2007 Apr 11.
•   Peduzzi P, Concato J, Kemper E, Holford TR, Feinstein AR
  A simulation study of the number of events per variable in logistic regression analysis. J Clin Epidemiol. 1996 Dec;49(12):1373-9.
•   Perkins FM, Kehlet H
  Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. Review.
•   Radovanovic D
  The use of transdermal fentanyl in the treatment of cancer pain. Arch Oncol 10:263-66, 2002.
•   Rahim-Williams FB, Riley JL 3rd, Herrera D, Campbell CM, Hastie BA, Fillingim RB
  Ethnic identity predicts experimental pain sensitivity in African Americans and Hispanics. Pain. 2007 May;129(1-2):177-84. Epub 2007 Feb 12.
•   Raja SN, Jensen TS
  Predicting postoperative pain based on preoperative pain perception: are we doing better than the weatherman? Anesthesiology. 2010 Jun;112(6):1311-2. doi: 10.1097/ALN.0b013e3181dcd5cc.
•   Rakvåg TT, Klepstad P, Baar C, Kvam TM, Dale O, Kaasa S, Krokan HE, Skorpen F
  The Val158Met polymorphism of the human catechol-O-methyltransferase (COMT) gene may influence morphine requirements in cancer pain patients. Pain. 2005 Jul;116(1-2):73-8.
•   Ramsay MA, Savege TM, Simpson BR, Goodwin R
  Controlled sedation with alphaxalone-alphadolone. Br Med J. 1974 Jun 22;2(5920):656-9.
•   Ramsay MA
  Anesthesia and pain management at Baylor University Medical Center. Proc (Bayl Univ Med Cent). 2000 Apr;13(2):151-65.
•   Reyes-Gibby CC, Shete S, Rakvåg T, Bhat SV, Skorpen F, Bruera E, Kaasa S, Klepstad P
  Exploring joint effects of genes and the clinical efficacy of morphine for cancer pain: OPRM1 and COMT gene. Pain. 2007 Jul;130(1-2):25-30. Epub 2006 Dec 6.
•   Ross JR, Rutter D, Welsh K, Joel SP, Goller K, Wells AU, Du Bois R, Riley J
  Clinical response to morphine in cancer patients and genetic variation in candidate genes. Pharmacogenomics J. 2005;5(5):324-36.
•   Sadhasivam S, Boat A, Mahmoud M
  Comparison of patient-controlled analgesia with and without dexmedetomidine following spine surgery in children. J Clin Anesth. 2009 Nov;21(7):493-501. doi: 10.1016/j.jclinane.2008.12.017.
•   Sadhasivam S, Cohen LL, Szabova A, Varughese A, Kurth CD, Willging P, Wang Y, Nick TG, Gunter J
  Real-time assessment of perioperative behaviors and prediction of perioperative outcomes. Anesth Analg. 2009 Mar;108(3):822-6. doi: 10.1213/ane.0b013e318195c115.
•   Sawyer MB, Innocenti F, Das S, Cheng C, Ramírez J, Pantle-Fisher FH, Wright C, Badner J, Pei D, Boyett JM, Cook E Jr, Ratain MJ
  A pharmacogenetic study of uridine diphosphate-glucuronosyltransferase 2B7 in patients receiving morphine. Clin Pharmacol Ther. 2003 Jun;73(6):566-74.
•   Shimada T, Yamazaki H, Mimura M, Inui Y, Guengerich FP
  Interindividual variations in human liver cytochrome P-450 enzymes involved in the oxidation of drugs, carcinogens and toxic chemicals: studies with liver microsomes of 30 Japanese and 30 Caucasians. J Pharmacol Exp Ther. 1994 Jul;270(1):414-23.
•   Silverstein JH, Rieders MF, McMullin M, Schulman S, Zahl K
  An analysis of the duration of fentanyl and its metabolites in urine and saliva. Anesth Analg. 1993 Mar;76(3):618-21.
•   Sinatra RS, Lodge K, Sibert K, Chung KS, Chung JH, Parker A Jr, Harrison DM
  A comparison of morphine, meperidine, and oxymorphone as utilized in patient-controlled analgesia following cesarean delivery. Anesthesiology. 1989 Apr;70(4):585-90.
•   Skorpen F, Laugsand EA, Klepstad P, Kaasa S
  Variable response to opioid treatment: any genetic predictors within sight? Palliat Med. 2008 Jun;22(4):310-27. doi: 10.1177/0269216308089302. Review.
•   Smith HS
  Opioid metabolism. Mayo Clin Proc. 2009 Jul;84(7):613-24. doi: 10.1016/S0025-6196(11)60750-7. Review.
•   Soetanto AL, Chung JW, Wong TK
  Are there gender differences in pain perception? J Neurosci Nurs. 2006 Jun;38(3):172-6.
•   Sommer M, de Rijke JM, van Kleef M, Kessels AG, Peters ML, Geurts JW, Gramke HF, Marcus MA
  The prevalence of postoperative pain in a sample of 1490 surgical inpatients. Eur J Anaesthesiol. 2008 Apr;25(4):267-74. Epub 2007 Dec 6.
•   Takeda S, Ishii Y, Iwanaga M, Mackenzie PI, Nagata K, Yamazoe Y, Oguri K, Yamada H
  Modulation of UDP-glucuronosyltransferase function by cytochrome P450: evidence for the alteration of UGT2B7-catalyzed glucuronidation of morphine by CYP3A4. Mol Pharmacol. 2005 Mar;67(3):665-72. Epub 2004 Dec 20.
•   Tan EC, Lim Y, Teo YY, Goh R, Law HY, Sia AT
  Ethnic differences in pain perception and patient-controlled analgesia usage for postoperative pain. J Pain. 2008 Sep;9(9):849-55. doi: 10.1016/j.jpain.2008.04.004. Epub 2008 Jun 12.
•   Van Slyke DA, Walker LS
  Mothers' responses to children's pain. Clin J Pain. 2006 May;22(4):387-91.
•   Vargas-Alarcón G, Fragoso JM, Cruz-Robles D, Vargas A, Vargas A, Lao-Villadóniga JI, García-Fructuoso F, Ramos-Kuri M, Hernández F, Springall R, Bojalil R, Vallejo M, Martínez-Lavín M
  Catechol-O-methyltransferase gene haplotypes in Mexican and Spanish patients with fibromyalgia. Arthritis Res Ther. 2007;9(5):R110.
•   Verghese ST, Hannallah RS
  Postoperative pain management in children. Anesthesiol Clin North Am. 2005 Mar;23(1):163-84. Review.
•   Voepel-Lewis T, Marinkovic A, Kostrzewa A, Tait AR, Malviya S
  The prevalence of and risk factors for adverse events in children receiving patient-controlled analgesia by proxy or patient-controlled analgesia after surgery. Anesth Analg. 2008 Jul;107(1):70-5. doi: 10.1213/ane.0b013e318172fa9e.
•   von Baeyer CL, Spagrud LJ, McCormick JC, Choo E, Neville K, Connelly MA
  Three new datasets supporting use of the Numerical Rating Scale (NRS-11) for children's self-reports of pain intensity. Pain. 2009 Jun;143(3):223-7. doi: 10.1016/j.pain.2009.03.002. Epub 2009 Apr 8.
•   Weinger M
  Dangers of postoperative opioids: APSF Workshop and White Paper address prevention of postoperative respiratory complications. APSF Newsletter 21:61-7, 2006
•   Werner MU, Mjöbo HN, Nielsen PR, Rudin A
  Prediction of postoperative pain: a systematic review of predictive experimental pain studies. Anesthesiology. 2010 Jun;112(6):1494-502. doi: 10.1097/ALN.0b013e3181dcd5a0. Review.
•   White PF, Kehlet H
  Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. Review.
•   Whitlock MC
  Combining probability from independent tests: the weighted Z-method is superior to Fisher's approach. J Evol Biol. 2005 Sep;18(5):1368-73.
•   Woodhouse A, Ward ME, Mather LE
  Intra-subject variability in post-operative patient-controlled analgesia (PCA): is the patient equally satisfied with morphine, pethidine and fentanyl? Pain. 1999 Apr;80(3):545-53.
•   Zanger UM, Turpeinen M, Klein K, Schwab M
  Functional pharmacogenetics/genomics of human cytochromes P450 involved in drug biotransformation. Anal Bioanal Chem. 2008 Nov;392(6):1093-108. doi: 10.1007/s00216-008-2291-6. Epub 2008 Aug 10. Review.
•   Zhang W, Chang YZ, Kan QC, Zhang LR, Li ZS, Lu H, Wang ZY, Chu QJ, Zhang J
  CYP3A4*1G genetic polymorphism influences CYP3A activity and response to fentanyl in Chinese gynecologic patients. Eur J Clin Pharmacol. 2010 Jan;66(1):61-6. doi: 10.1007/s00228-009-0726-4. Epub 2009 Sep 26.
•   Zheng M
  Isolation, identification and synthesis of hydromorphone metabolites: analysis and antinociceptive activities in comparison to morphine. 1997.
•   Zubieta JK, Heitzeg MM, Smith YR, Bueller JA, Xu K, Xu Y, Koeppe RA, Stohler CS, Goldman D
  COMT val158met genotype affects mu-opioid neurotransmitter responses to a pain stressor. Science. 2003 Feb 21;299(5610):1240-3.

Non-Interventional Pharmacogenetic Study of Patient / Proxy Controlled Analgesia in Children Undergoing Surgery

Details for clinical trial NCT01731873