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Table 2: Randomized controlled trials assessing analgesics for pain and inappropriate use of clinically relevant difference from references cited to justify values
ReferenceTrial ADDIN EN.CITE Collins2005333317Collins, S. D.Chessell, I. P.GlaxoSmithKline, Neurology & Gastrointestinal Centre of Excellence for Drug Discovery, New Frontiers Science Park, Third Avenue, Harlow, Essex, CM19 5AW, UK. Sue.D.Collins@gsk.comEmerging therapies for neuropathic painExpert Opin Emerg Drugs.Expert Opin Emerg Drugs.95-108.101Analgesics/*therapeutic useAnimalsClinical Trials/trendsDrugs, Investigational/*therapeutic useHumansPain/*drug therapy/pathologyPolyneuropathies/*drug therapy/pathology2005Feb15757406Collins and Chessell [23]: The threshold for acceptable pain was 30 mm at the individual level. ADDIN EN.CITE Lipscomb2006171717Lipscomb, G. H.Roberts, K. A.Givens, V. M.Robbins, D.Division of Gynecologic Specialties, Department of Obstetrics and Gynecology, University of Tennessee Health Science Center, Memphis, TN, USA. glipscomb@utmem.eduA trial that compares Monsel's paste with ball electrode for hemostasis after loop electrosurgical excision procedureAm J Obstet Gynecol.Am J Obstet Gynecol.1591-4; discussion 1595. Epub 2006 Mar 30.1946AdultCervix Uteri/physiopathology/*surgery*Electrocoagulation/instrumentation*ElectrodesEquipment DesignFemaleFerric Compounds/*therapeutic use*Hemostatic Techniques/instrumentationHemostatics/*therapeutic useHumansPain MeasurementPain, Postoperative/physiopathology*Postoperative CareSulfates/*therapeutic useTreatment Outcome2006Jun16579924Lipscomb et al. [24]: Difference between groups was considered not clinically relevant because both group means were < 30 mm. ADDIN EN.CITE Farrar2001343417Farrar, J. T.Young, J. P., Jr.LaMoreaux, L.Werth, J. L.Poole, R. M.Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Blockley Hall, Room 816, 423 Guardian Drive, Philadelphia, PA 19104, USA. jfarrar@cceb.med.upenn.eduClinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scalePain.Pain.149-58.942AdultAgedAged, 80 and overAnticonvulsants/therapeutic useChronic DiseaseControlled Clinical Trials/methods/standardsFemaleFibromyalgia/diagnosis/drug therapyHumansLow Back Pain/diagnosis/*drug therapyMaleMiddle AgedNeuralgia/diagnosis/drug therapyOsteoarthritis/diagnosis/drug therapyPain Measurement/*standardsTreatment Outcomegamma-Aminobutyric Acid/*analogs & derivatives/*therapeutic use2001Nov11690728Farrar et al. [18]: The clinical improvement was 20 mm or 30% of improvement at the individual level. ADDIN EN.CITE Berry2005232317Berry, J. D.Petersen, K. L.UCSF Pain Clinical Research Center, Department of Neurology, University of California, San Francisco, CA, USA.A single dose of gabapentin reduces acute pain and allodynia in patients with herpes zosterNeurology.Neurology.444-7.653Acute Disease/therapyAdultAgedAged, 80 and overAmines/*administration & dosage/therapeutic useAnalgesics/administration & dosage/therapeutic useAnticonvulsants/administration & dosage/therapeutic useCross-Over StudiesCyclohexanecarboxylic Acids/*administration & dosage/therapeutic useDose-Response Relationship, DrugDouble-Blind MethodDrug Administration ScheduleFemaleHerpes Zoster/*complications/physiopathologyHumansHyperalgesia/*drug therapy/etiology/physiopathologyMaleMiddle AgedPain MeasurementPain Threshold/*drug effects/physiologyTreatment Outcomegamma-Aminobutyric Acid/*administration & dosage/therapeutic use2005Aug 916087911Berry and Petersen [25]: The value of 30% was used at the group level in the sample size calculation. ADDIN EN.CITE Farrar2001343417Farrar, J. T.Young, J. P., Jr.LaMoreaux, L.Werth, J. L.Poole, R. M.Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Blockley Hall, Room 816, 423 Guardian Drive, Philadelphia, PA 19104, USA. jfarrar@cceb.med.upenn.eduClinical importance of changes in chronic pain intensity measured on an 11-point numerical pain rating scalePain.Pain.149-58.942AdultAgedAged, 80 and overAnticonvulsants/therapeutic useChronic DiseaseControlled Clinical Trials/methods/standardsFemaleFibromyalgia/diagnosis/drug therapyHumansLow Back Pain/diagnosis/*drug therapyMaleMiddle AgedNeuralgia/diagnosis/drug therapyOsteoarthritis/diagnosis/drug therapyPain Measurement/*standardsTreatment Outcomegamma-Aminobutyric Acid/*analogs & derivatives/*therapeutic use2001Nov11690728Farrar et al. [18]: The clinical improvement was 20 mm or 30% of improvement at the individual level. ADDIN EN.CITE Qerama2006141417Qerama, E.Fuglsang-Frederiksen, A.Kasch, H.Bach, F. W.Jensen, T. S.Danish Pain Research Center, Aarhus University Hospital, Denmark. erisela@akhphd.au.dkA double-blind, controlled study of botulinum toxin A in chronic myofascial painNeurology.Neurology.241-5.672Analgesics/therapeutic useBotulinum Toxin Type A/*therapeutic useChronic DiseaseDouble-Blind MethodFemaleHumansMaleMiddle AgedMyofascial Pain Syndromes/*diagnosis/*drug therapyPain Measurement/*drug effectsPain Threshold/*drug effectsPlacebo EffectTreatment Outcome2006Jul 2516864815Qerama et al. [17]: A 25% to 30% reduction from baseline was expected in the experimental group. ADDIN EN.CITE Farrar2003373717Farrar, J. T.Berlin, J. A.Strom, B. L.University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA.Clinically important changes in acute pain outcome measures: a validation studyJ Pain Symptom Manage.J Pain Symptom Manage.406-11.255Acute DiseaseAdministration, BuccalAnalgesics, Opioid/administration & dosage/*therapeutic useFentanyl/administration & dosage/*therapeutic useHumansNeoplasms/*complications*Outcome Assessment (Health Care)Pain/*drug therapy/*etiology*Pain MeasurementReproducibility of ResultsSensitivity and Specificity2003May12727037Farrar et al. [26]: The clinical improvement was 20 mm or 33% of improvement at the individual level. ADDIN EN.CITE Suzuki20066617Suzuki, M.Haraguti, S.Sugimoto, K.Kikutani, T.Shimada, Y.Sakamoto, A.Department of Anesthesiology, Second Hospital Nippon Medical School, Kanagawa, Japan. manzo@nms.ac.jpLow-dose intravenous ketamine potentiates epidural analgesia after thoracotomyAnesthesiology.Anesthesiology.111-9.1051AgedAged, 80 and overAnalgesia, Epidural/*methodsAnalgesics/administration & dosageDouble-Blind MethodDrug SynergismFemaleHumansKetamine/*administration & dosageMaleMiddle AgedPain Measurement/drug effects/methodsPain, Postoperative/*drug therapy/epidemiology/pathology*Thoracotomy/adverse effects2006Jul16810002Suzuki et al. [27]: The mean improvement in the experimental group was considered too small (< 20 mm) to be relevant. ADDIN EN.CITE Felson1995414117Felson, D. T.Anderson, J. J.Boers, M.Bombardier, C.Furst, D.Goldsmith, C.Katz, L. M.Lightfoot, R., Jr.Paulus, H.Strand, V.et al.,Boston University Arthritis Center, Massachusetts, USA.American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritisArthritis Rheum.Arthritis Rheum.727-35.386AdultAgedAnti-Inflammatory Agents/*standards/therapeutic useArthritis, Rheumatoid/*drug therapy/physiopathologyClinical TrialsFemaleHumansJoints/physiopathologyMaleMiddle Aged*Outcome Assessment (Health Care)Severity of Illness IndexSocieties, Medical1995Jun7779114Felson et al. [28]: An improvement of 20% significant at the individual level. ADDIN EN.CITE Wong2005252517Wong, S. M.Hui, A. C.Tong, P. Y.Poon, D. W.Yu, E.Wong, L. K.North District Hospital, The Chinese University of Hong Kong, and Prince of Wales Hospital, Hong Kong, China. jsmwong@hkstar.comTreatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trialAnn Intern Med.Ann Intern Med.793-7.14311AdultBotulinum Toxin Type A/adverse effects/*therapeutic useDouble-Blind MethodFemaleFingers/innervationHand StrengthHumansInjectionsMaleMiddle AgedPain/etiology/prevention & controlParesis/chemically inducedProspective StudiesTennis Elbow/*drug therapy/physiopathologyTreatment Outcome2005Dec 616330790Wong et al. [29]: The authors concluded that the results for the experimental and placebo groups might be the same because the lower boundary of the confidence interval for the between-groups differences in means was < 20% of improvement. ADDIN EN.CITE McQuay2003454517McQuay, H. J.Barden, J.Moore, R. A.Clinically important changes-what's important and whose change is it anyway?J Pain Symptom Manage.J Pain Symptom Manage.395-6.255*Biomedical ResearchHumans*Outcome Assessment (Health Care)Pain/*diagnosis/*therapyPain Measurement2003May12727031McQuay et al. [30]: An significant improvement was a 30% decrease from baseline at the individual level. ADDIN EN.CITE Langford2006111117Langford, R.McKenna, F.Ratcliffe, S.Vojtassak, J.Richarz, U.Pain Research Group, Barts and The London NHS Trust, London, UK.Transdermal fentanyl for improvement of pain and functioning in osteoarthritis: a randomized, placebo-controlled trialArthritis Rheum.Arthritis Rheum.1829-37.546Administration, CutaneousAdultAgedAged, 80 and overAnalgesics, Opioid/*therapeutic useFemaleFentanyl/*administration & dosageHumansMaleMiddle AgedOsteoarthritis/*drug therapy/physiopathologyOsteoarthritis, Hip/drug therapy/physiopathologyOsteoarthritis, Knee/drug therapy/physiopathologyPain/drug therapyPain Measurement2006Jun16729276Langford et al. [31]: For the sample size calculation, the expected difference between groups at endpoint was an absolute difference in means of 10 mm or a relative change of 38% at the group level. The authors did not specify which value they used in the sample size calculation. ADDIN EN.CITE DeLoach1998494917DeLoach, L. J.Higgins, M. S.Caplan, A. B.Stiff, J. L.Department of Anesthesiology, Johns Hopkins Bayview Medical Center, Baltimore, MD 21224, USA.The visual analog scale in the immediate postoperative period: intrasubject variability and correlation with a numeric scaleAnesth Analg.Anesth Analg.102-6.861AdolescentAdultAgedAged, 80 and overHumansMiddle Aged*Pain MeasurementPain, Postoperative/*diagnosis/drug therapy1998Jan9428860DeLoach et al. [22]: Defined a threshold of imprecision at 20 mm at the individual level ADDIN EN.CITE Rattanachaiyanont2005292917Rattanachaiyanont, M.Leerasiri, P.Indhavivadhana, S.Gynecologic Endocrinology Unit, Division of Reproductive Medicine, Department of Obstetrics and Gynecology, Faculty of Medicine, Siriraj Hospital, Mahidol University, Thailand. simrt@mahidol.ac.thEffectiveness of intrauterine anesthesia for pain relief during fractional curettageObstet Gynecol.Obstet Gynecol.533-9.1063Administration, IntravaginalAdult*Anesthesia, ObstetricalAnesthetics, Local/*administration & dosage*Dilatation and CurettageDouble-Blind MethodFemaleHumansLidocaine/*administration & dosagePain MeasurementUterine Hemorrhage/surgery2005Sep16135583Rattanachaiyanont et al. [21]: Expected difference in means was 20 mm between groups.
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