Acetaminophen Davis
2021年10月25日Download here: http://gg.gg/wb9g3
Remy C., Marret E., Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major surgery: meta-analysis of randomized. View topics in the All Topics B section of Davis’s Drug Guide. Davis’s Drug Guide for Nurses App + Web from F.A. Davis and Unbound Medicine covers 5000+ trade name and generic drugs.
*Acetaminophen Davis Drug Book
*Acetaminophen Davis Plus
*Acetaminophen Davis Drug Card Pdf
Type your tag names separated by a space and hit enterbutalbital, acetaminophen, caffeine† is a topic covered in the Davis’s Drug Guide.
To view the entire topic, please log in or purchase a subscription.
The Harriet Lane Handbook app and website provides pediatric diagnosis and treatment, pediatric management algorithms, and pediatric drug formulary from experts at Johns Hopkins University. Explore these free sample topics:
Analgesia and Procedural Sedation
Methylprednisolone
Acetazolamide
TABLE 7-12: ACYANOTIC CONGENITAL HEART DISEASE
Procedures
-- The first section of this topic is shown below --General
Pronunciation: byoo-tal-bi-tal, a-seet-a-min-oh-fen, kaf-eenTo hear audio pronunciation of this topic, purchase a subscription or log in.
Trade Name(s)
*Fioricet
Ther. Class.nonopioid analgesics (combination with barbiturate)
Pharm. Class.barbiturates† For information on acetaminophen component in formulation, see acetaminophen monograph
-- To view the remaining sections of this topic, please log in or purchase a subscription --
Pronunciation: byoo-tal-bi-tal, a-seet-a-min-oh-fen, kaf-eenTo hear audio pronunciation of this topic, purchase a subscription or log in.
Trade Name(s)
*Fioricet
Ther. Class.nonopioid analgesics (combination with barbiturate)
Pharm. Class.barbiturates† For information on acetaminophen component in formulation, see acetaminophen monograph
There’s more to see -- the rest of this entry is available only to subscribers.CitationVallerand, April Hazard., et al. ’Butalbital, Acetaminophen, Caffeine†.’ Davis’s Drug Guide, 16th ed., F.A. Davis Company, 2020. Harriet Lane, www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†. Vallerand AHA, Sanoski CAC, Quiring CC. Butalbital, acetaminophen, caffeine†. Davis’s Drug Guide. F.A. Davis Company; 2020. https://www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†. Accessed May 19, 2021.Vallerand, A. H., Sanoski, C. A., & Quiring, C. (2020). Butalbital, acetaminophen, caffeine†. In Davis’s Drug Guide (16th edition). F.A. Davis Company. https://www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†Vallerand AHA, Sanoski CAC, Quiring CC. Butalbital, Acetaminophen, Caffeine† [Internet]. In: Davis’s Drug Guide. F.A. Davis Company; 2020. [cited 2021 May 19]. Available from: https://www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†.* Article titles in AMA citation format should be in sentence-caseTY - ELECT1 - butalbital, acetaminophen, caffeine†ID - 110813A1 - Sanoski,Cynthia A,AU - Vallerand,April Hazard,AU - Quiring,Courtney,BT - Davis’s Drug GuideUR - https://www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†PB - F.A. Davis CompanyET - 16DB - Harriet LaneDP - Unbound MedicineER - EFFECT SIZE OF ANALGESIC AGENTS ON KEY OUTCOME VARIABLES IN OSTEOARTHRITIS P. Peloso, N. Babul, Department of Internal Medicine, University of Iowa Hospital and Clinics, Iowa City, IA , Clinical Drug Development, TheraQuest Biosciences, East Norriton, PAAim of Investigation: A wide variety of pharmacologic agents are used singly or in combination to treat the symptoms of osteoarthritis, including NSAIDs, COX-2 inhibitors and opioids. Although information on minimum clinically important and perceptible differences in osteoarthritis is available, selection of therapy is at least partly based on clinician perceptions about relative safety and efficacy. The purpose of this study was to compare the true effect size following therapeutic doses of agents commonly used to treat OA. Methods: A literature search of Medline was conducted to obtain data on randomized, double blind, placebo controlled trials of analgesics in osteoarthritis. To minimize publication bias, data submitted to the FDA were also obtained under the Freedom of Information. Data on overall pain intensity, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores for index joint pain, stiffness and physical function subscale scores and patient global were collected. The True Effect Size was expressed as the response on drug, less the response on placebo ([ Drug/Baseline Drug] [ Placebo/Baseline Placebo] x 100%). Results: For index joint pain intensity, the True Effect Size range for NSAIDS, COX-2 inhibitors and opioids were 8-18%, 9-23% and 23-39%, respectively. Conclusions: There was considerable intra-drug and inter-drug variability in response. Interpretation of data was hampered by differences in study design (flare vs. washout; rescue; primary vs. add-on therapy), statistical approaches (choice of primary efficacy variable and endpoint; intent-to-treat vs. evaluable population; imputation techniques) and dose of study drug.EFFECTS OF INTRAVENOUS KETOROLAC AND FENTANYL ON ANALGESIA AND SIDE EFFECTS DURING EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY C. Cherng, Anesthesiology Tri-Service General Hospital, National Defense Medical Center., Taipei, TaiwanAIM OF INVESTIGATION: This study was to compared the effects of intravenous ketorolac and fentanyl on analgesia and side effects during extracorporeal shock wave lithotripsy (ESWL). METHODS: Sixty patients were divided into two groups randomly, group K (n=30) received 60 mg ketorolac (i.v.) 30 min before ESWL and group F (n=30) received 100 microgram fentanyl (i.v.) 3 min before ESWL. All patients received 2.5 mg midazolam 3 min before ESWL for intraoperative sedation. The pain intensity was evaluated by a numeric rating scale (NRS). A supplemental analgesia was administered by 25 microgram fentanyl when inadequate analgesia occurred (NRS>3). Oxygen supplement with face mask was given when SpO2 below 94%. Side effects (nausea, vomiting, dizziness) and the discharge times from PAR were recorded. The discharge criterion was defined as there was no any discomfort even when standing up. RESULTS: There was no difference between two groups in demographic data, number of shock waves, duration of ESWL procedure, and fentanyl supplement. The incidence of oxygen supplement was lower in ketorolac group (1/30) than that of fentanyl group (20/30), p<0.01. The frequency of dizziness was lower in ketorolac group (1/30) than that of fentanyl group (25/30), p<0.01. Three patients in fentanyl group complained of nausea, but none in ketorolac group. The discharge time from PAR was significantly shorter in ketorolac group (13.78.4 min) than that of fentanyl group (49.514.6 min), p<0.01. CONCLUSIONS: Both intravenous ketorolac and fentanyl could provide good analgesia for ESWL. However, ketorolac demonstrated less side effects and shorter discharge time from PAR.EFFECTS OF A SINGLE DOSE OF ACETYLSALICYLIC ACID ON SORE THROAT PAIN, AND OTHER PAIN SYMPTOMS, ASSOCIATED WITH ACUTE UPPER RESPIRATORY TRACT INFECTION R. Eccles, L. Nyman, I. Loose, Common Cold Centre, Cardiff University, Cardiff, United Kingdom , Quintiles AB, Quintiles, Uppsala, Sweden , Consumer Care, Bayer AG, Leverkusen, GermanyAIM OF INVESTIGATION: Acetylsalicylic acid (ASA) has a long tradition in the treatment of symptoms of acute upper respiratory tract infection (URTI) yet modern clinical trials data is sparse for this indication. This study investigates the efficacy and safety of a single dose of 800mg ASA on treatment of pain symptoms associated with URTI. METHODS: A double blind, placebo controlled, parallel group design. Patients with sore throat pain associated with URTI were recruited at two centres. They were treated with either two effervescent tablets of ASA 400mg in water or matched placebo tablets. Primary study objective was sum of sore throat pain intensity differences (SPID) for 0-2hours. Pain and pain relief scores were made during a two hour in patient phase and continued for secondary objectives during a four hours home phase. RESULTS: 272 of 279 patients fulfilled all protocol requirements. ASA was found to be superior to placebo for SPID 0-2hours (p < 0.0001). It was also superior to placebo in the reduction in sore throat pain intensity, and relief of sore throat pain for 2,4 and 6 hours (p < 0.002); reduction in intensity of pain associated with headache (p < 0.002), and muscle aches and pains (p < 0.02) at 2 hours. No safety problems were encountered. CONCLUSIONS: Treatment with ASA has been shown to provide relief from sore throat pain, headache, and muscle aches and pains associated with URTI. ACKNOWLEDGEMENTS: This study was sponsored by Bayer AG, Germany.SAFETY AND EFFICACY OF REPEATED DOSES OF DEXKETOPROFEN TROMETAMOL I.V. IN THE MANAGEMENT OF POST-ORTHOPAEDIC SURGICAL PAIN H. Zippel, R. Artigas, M. Bertolotti, A. Capriati, M. Ballarin, Abteilung Orthopdie, Humboldt, Universitt Charit, Berlin, Germany , Clinical Research, Menarini Ricerche S.p.A., Florence, ItalyAim of investigation: To evaluate the safety and analgesic efficacy of repeated I.V. administrations of dexketoprofen trometamol (DKP.TRIS) in patients following major orthopaedic surgery. Methods: A total of 252 pts, presenting with moderate-severe pain within 12 h post recovery from general anaesthesia after hip or knee replacement surgery, were randomised to receive DKP.TRIS 50 mg or to ketoprofen (KP) 100 mg (100 ml infusion over 30 min every 8 h for two days). Rescue medication included paracetamol or morphine; PCA was not allowed. The primary end-point for efficacy was pain intensity reduction measured by SAPID0-8h. Safety was evaluated by monitoring lab parameters and AEs. Results: The study population encompassed 60% M; the mean age was 60 y; 70% undergoing hip replacement. Baseline pain intensity was scored as severe (mean VAS=75 mm). A marked pain relief was obtained following the first dose of both DKP.TRIS and KP (SAPID0-8h=311 and 326 mm.h); pain remained controlled during the study period (mean PID after 8h from start of each dose administration=43 and 47 mm). As expected, rescue medication was taken by the majority of pts, with no overt difference between DKP.TRIS and KP (81% vs 87%). A good safety profile was observed with 16% and 21% pts reporting ADRs in DKP.TRIS and KP groups, respectively. The rate of AEs, including bleeding, did not differ in pts treated with heparin or low molecular weigh heparin for the prophyilaxis of thrombo-embolic complication. Conclusion: DKP-TRIS given as 50 mg I.V. t.i.d. was safe and efficient in the management of severe post-orthopaedic pain. Acknowledgments: Supported by grants from Menarini Ricerche S.p.A.DEXKETOPROFEN TROMETAMOL VERSUS TRAMADOL IN THE RELIEF OF PAIN FOLLOWING MAJOR ORTHOPAEDIC SURGERY S. Peat, I. Paredes, A. Capriati, Dept. of Anaesthetics, King’s College Hospital, London, United Kingdom , Clinical Research, Menarini Ricerche S.p.A., Florence, ItalyAim of investigation: To evaluate the efficacy and safety of dexketoprofen trometamol (DKT.TRIS) versus tramadol (T) in the control of pain following major orthopaedic surgery. Methods: 215 M and F patients (age 18-75) undergoing primary hip or knee replacement were randomised to receive 50 mg DKP.TRIS (over 30 min), 100 mg T (bolus) or placebo (P) given I.V. according to a double blind, double-dummy design. All pts also received I.V. morphine (M) via a PCA system. A first dose of study medication was given 30 min prior to the estimated ’waking time’ (first response to verbal command); a second dose was given 6 h later. M usage, pain intensity (rated by the patient using a VAS), nausea and sedation were regularly assessed up to 12 h post dose. Results: The population had a mean age of 60 y; M/F=50%; 80% underwent hip replacement. A clear and statistically significant reduction in mean M usage was obtained after DKP.TRIS and T vs P (meanSD=1.71.0 and 1.60.8 vs 2.21.0 mg/h, respectively). Pain was well controlled (VAS<30) within the first 4, 6 and 10 h after DKP.TRIS, T and P respectively, with DKP.TRIS group obtaining the lowest pain scores from 2-12 h and less sedation than T group (77.8% vs 85.3%, ns). No difference in the overall AE profile, including nausea, was evident between treatments. Conclusion: DKP.TRIS demonstrated a significant M sparing effect when used for the control of pain following major joint surgery. In combination with PCA M, a trend of superiority of DKP.TRIS vs T was observed in terms of time to obtain pain control as well as overall analgesic effect, with a lower degree of sedation. Acknowledgments: Supported by grants from Menarini Ricerche S.p.A.ANTI-INFLAMMATORY EFFECTS OF CELECOXIB AFTER INFERIOR INCLUDED THIRD MOLAR SURGERY .P. Posso, J.O. Arantes, G. Neder, V.M. Medicine, Universidade de So Paulo, Sгo Paulo, BrazilAim of investigation: To study the anti-inflammatory effect of COX2 inhibitor celecoxib. Methods: It was evaluated 15 patients that had their inferior bilateral included third molar removed, one at a time (30 surgeries). Celecoxib or placebo were given to patients 3 hours before surgery. Group 1 received celecoxib before surgery and placebo right after it and group 2 had placebo before surgery and celecoxib right after it. Dipyrone was the rescue drug. The inflammation was evaluated by the mouth open measure between the incisal zone of superior and inferior incisors teeth. There were taken four measures: before surgery, right after, 24 and 48 hours after it. Results: Before surgery the open mouth measure average to group 1 was 50.875.40 and to the group 2 was 50.624.20. Right after surgery the open mouth measure average to group 1 was 49.064.83 and to the group 2 was 49.125.11. 24 h after surgery the open mouth measure average to group 1 was 38.3514.21 and to the group 2 was 39.4312.98 and 48h after surgery the open mouth measure average to group 1 was 41.7812.84 and to the group 2 was 40.0312.95. There were no statistic relevant values in this study. Conclusions: The use of celecoxib before inferior included third molar surgery does not change the inflammatory patterns. Acknowledgments: Supported by FAPESP.OPIOID-SPARING EFFECT OF ROFECOXIB COMPARED WITH DICLOFENAC IN ACUTE PAIN: A RANDOMIZED CONTROLLED TRIAL D.J. Chang, E. Chen, A.B. Polis, M. McAvoy, S.H. Mockoviak, G.P. Geba Clinical Development, Merck & Co., Inc., West Pont, PA , Clinical Site Operations, SCIREX Corporation, Austin, TXAim of Investigation: To compare the opioid-sparing effect of rofecoxib and diclofenac in acute pain over 24 hours. Methods: Patients experiencing moderate to severe pain after 3rd molar surgery were randomized to rofecoxib 50 mg (1 dose), diclofenac sodium 50 mg q8 hours (3 doses), or placebo. Use of opioid rescue medication (hydrocodone/acetaminophen 5/500 mg) was recorded. Patients also rated their pain and global assessments throughout 24 hours. Results: 305 patients were randomized to rofecoxib (N=121), diclofenac (N=121), or placebo (N=63). Fewer patients treated with a dose of rofecoxib required opioid medication than patients treated with a dose of diclofenac during 8 hours (19.8% vs 66.9%) and 3 doses of diclofenac during 24 hours (28.9% vs 76.0%). On average, rofecoxib patients required less opioid tablets than diclofenac patients during 8 hours (0.3 vs 1.0 per patient) and 24 hours (0.7 vs 1.9 per patient). Rofecoxib provided greater overall pain relief and patient global assessment scores than diclofenac over 8 and 24 hours. Rofecoxib patients achieved greater maximum analgesic effect, more rapid onset (31 minutes), and longer analgesic duration (>24 hours) than diclofenac patients. For all endpoints, the differences were significant (P<0.001). Conclusion: Compared with diclofenac sodium 50 mgeither 1 dose over 8 hours or 3 doses over 24 hoursa single dose of rofecoxib 50 mg demonstrated a significant reduction in opioid use and provided greater analgesic efficacy.Acknowledgement: Supported by Merck & Co., Inc. Authors Chang, Chen, Polis, McAvoy, Mockoviak, and Geba are employees of Merck & Co., IncEFFICACY AND SAFETY OF A SINGLE DOSE OF IV PARECOXIB SODIUM (PARE) FOLLOWED BY UP TO SEVEN DAYS OF ORAL VALDECOXIB (VALDE) FOR PAIN FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY H. Minkowitz, T.J. Gan, R. Cheung, R. Hubbard, C. Chen, J.G. Fort, Dept of Anes, Memorial City Hospital, Houston, TX , 2 Dept of Anes, University of Texas Southwest MCC, Dallas, TX , Dept of Anes, Duke University Medical Center, Durham, NC , 4 Global Medical Affairs, Pharmacia, Peapack, NJ , R&D, Pharmacia, Skokie, IL , 6 Global Health Outcomes, Pharmacia, Skokie, ILAim of Investigation: To evaluate a single preop dose of pare 40mg iv and postop oral valde 40 mg QD. Methods: In this randomized, d-b, p-c trial pts received standard of care, fentanyl PRN in immediate postop period and APAP 500 mg/hydrocodone 5 mg po Q4-6H PRN following discharge for up to 7 days. The active arm also received pare 40mg iv 3045 min preop and valde 40mg QD po from 6-12h after surgery, for up to 7 days. ’Worst Pain’ was evaluated daily using a modified Brief Pain Inventory (mBPI). Results: In immediate postop period (4H), pare pts (n=119) required significantly lower amounts of fentanyl (152.8g vs 192.9g: p=0.011) than comparator (n=104). Signif. fewer valde pts required supplemental analgesia over Days 1-5 postsurgery (p<0.02). Worst pain scores were also statistically signif. improved in valde group vs placebo. % pts reporting worst pain as none or mild (NRS4) in the valde and placebo group on Day 1 was 63.1% vs 29.2% (p<0.001); Day 2 69.2% vs 56.0% (p<0.02). Adverse events were comparable between groups. Conclusions: Preop pare 40mg iv resulted in signif. opioid-sparing immediately following lap chole surgery. Valde 40mg QD provided signift opioid-sparing effects and reduced worst pain levels in these pts following discharge. Both pare and valde were well tolerated. Disclosure: Sponsored by Pharmacia and Pfizer Inc.TREATMENT OF CHRONIC LOW BACK PAIN WITH ETORICOXIB, A NEW CYCLO-OXYGENASE-2 SELECTIVE INHIBITOR: A 3 MONTH PLACEBO-CONTROLLED TRIAL. G.P. Geba, J. Adler E. Quaidoo4 R. Lipetz, R. Pallay, C. Skalky, K. O’Brien, N. Bohidar, Merck & Co., Inc., West Point, PA , Health First Medical Group, Fort Worth, TX , Clinicos, Colorado Springs, CO , AAIR Research Center, Rochester, NY , Encompass Clinical Research, Spring Valley, CA , Robert Wood Johnson, Belle Mead, NJAim of Investigation: To evaluate the efficacy of etoricoxib (ETO) 60 mg and 90 mg for treatment of chronic low back pain (LBP). Methods: The 325 patients received daily ETO 60 mg (n=109) or 90
https://diarynote.indered.space
Remy C., Marret E., Bonnet F. Effects of acetaminophen on morphine side-effects and consumption after major surgery: meta-analysis of randomized. View topics in the All Topics B section of Davis’s Drug Guide. Davis’s Drug Guide for Nurses App + Web from F.A. Davis and Unbound Medicine covers 5000+ trade name and generic drugs.
*Acetaminophen Davis Drug Book
*Acetaminophen Davis Plus
*Acetaminophen Davis Drug Card Pdf
Type your tag names separated by a space and hit enterbutalbital, acetaminophen, caffeine† is a topic covered in the Davis’s Drug Guide.
To view the entire topic, please log in or purchase a subscription.
The Harriet Lane Handbook app and website provides pediatric diagnosis and treatment, pediatric management algorithms, and pediatric drug formulary from experts at Johns Hopkins University. Explore these free sample topics:
Analgesia and Procedural Sedation
Methylprednisolone
Acetazolamide
TABLE 7-12: ACYANOTIC CONGENITAL HEART DISEASE
Procedures
-- The first section of this topic is shown below --General
Pronunciation: byoo-tal-bi-tal, a-seet-a-min-oh-fen, kaf-eenTo hear audio pronunciation of this topic, purchase a subscription or log in.
Trade Name(s)
*Fioricet
Ther. Class.nonopioid analgesics (combination with barbiturate)
Pharm. Class.barbiturates† For information on acetaminophen component in formulation, see acetaminophen monograph
-- To view the remaining sections of this topic, please log in or purchase a subscription --
Pronunciation: byoo-tal-bi-tal, a-seet-a-min-oh-fen, kaf-eenTo hear audio pronunciation of this topic, purchase a subscription or log in.
Trade Name(s)
*Fioricet
Ther. Class.nonopioid analgesics (combination with barbiturate)
Pharm. Class.barbiturates† For information on acetaminophen component in formulation, see acetaminophen monograph
There’s more to see -- the rest of this entry is available only to subscribers.CitationVallerand, April Hazard., et al. ’Butalbital, Acetaminophen, Caffeine†.’ Davis’s Drug Guide, 16th ed., F.A. Davis Company, 2020. Harriet Lane, www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†. Vallerand AHA, Sanoski CAC, Quiring CC. Butalbital, acetaminophen, caffeine†. Davis’s Drug Guide. F.A. Davis Company; 2020. https://www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†. Accessed May 19, 2021.Vallerand, A. H., Sanoski, C. A., & Quiring, C. (2020). Butalbital, acetaminophen, caffeine†. In Davis’s Drug Guide (16th edition). F.A. Davis Company. https://www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†Vallerand AHA, Sanoski CAC, Quiring CC. Butalbital, Acetaminophen, Caffeine† [Internet]. In: Davis’s Drug Guide. F.A. Davis Company; 2020. [cited 2021 May 19]. Available from: https://www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†.* Article titles in AMA citation format should be in sentence-caseTY - ELECT1 - butalbital, acetaminophen, caffeine†ID - 110813A1 - Sanoski,Cynthia A,AU - Vallerand,April Hazard,AU - Quiring,Courtney,BT - Davis’s Drug GuideUR - https://www.unboundmedicine.com/harrietlane/view/Davis-Drug-Guide/110813/all/butalbital__acetaminophen__caffeine†PB - F.A. Davis CompanyET - 16DB - Harriet LaneDP - Unbound MedicineER - EFFECT SIZE OF ANALGESIC AGENTS ON KEY OUTCOME VARIABLES IN OSTEOARTHRITIS P. Peloso, N. Babul, Department of Internal Medicine, University of Iowa Hospital and Clinics, Iowa City, IA , Clinical Drug Development, TheraQuest Biosciences, East Norriton, PAAim of Investigation: A wide variety of pharmacologic agents are used singly or in combination to treat the symptoms of osteoarthritis, including NSAIDs, COX-2 inhibitors and opioids. Although information on minimum clinically important and perceptible differences in osteoarthritis is available, selection of therapy is at least partly based on clinician perceptions about relative safety and efficacy. The purpose of this study was to compare the true effect size following therapeutic doses of agents commonly used to treat OA. Methods: A literature search of Medline was conducted to obtain data on randomized, double blind, placebo controlled trials of analgesics in osteoarthritis. To minimize publication bias, data submitted to the FDA were also obtained under the Freedom of Information. Data on overall pain intensity, Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scores for index joint pain, stiffness and physical function subscale scores and patient global were collected. The True Effect Size was expressed as the response on drug, less the response on placebo ([ Drug/Baseline Drug] [ Placebo/Baseline Placebo] x 100%). Results: For index joint pain intensity, the True Effect Size range for NSAIDS, COX-2 inhibitors and opioids were 8-18%, 9-23% and 23-39%, respectively. Conclusions: There was considerable intra-drug and inter-drug variability in response. Interpretation of data was hampered by differences in study design (flare vs. washout; rescue; primary vs. add-on therapy), statistical approaches (choice of primary efficacy variable and endpoint; intent-to-treat vs. evaluable population; imputation techniques) and dose of study drug.EFFECTS OF INTRAVENOUS KETOROLAC AND FENTANYL ON ANALGESIA AND SIDE EFFECTS DURING EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY C. Cherng, Anesthesiology Tri-Service General Hospital, National Defense Medical Center., Taipei, TaiwanAIM OF INVESTIGATION: This study was to compared the effects of intravenous ketorolac and fentanyl on analgesia and side effects during extracorporeal shock wave lithotripsy (ESWL). METHODS: Sixty patients were divided into two groups randomly, group K (n=30) received 60 mg ketorolac (i.v.) 30 min before ESWL and group F (n=30) received 100 microgram fentanyl (i.v.) 3 min before ESWL. All patients received 2.5 mg midazolam 3 min before ESWL for intraoperative sedation. The pain intensity was evaluated by a numeric rating scale (NRS). A supplemental analgesia was administered by 25 microgram fentanyl when inadequate analgesia occurred (NRS>3). Oxygen supplement with face mask was given when SpO2 below 94%. Side effects (nausea, vomiting, dizziness) and the discharge times from PAR were recorded. The discharge criterion was defined as there was no any discomfort even when standing up. RESULTS: There was no difference between two groups in demographic data, number of shock waves, duration of ESWL procedure, and fentanyl supplement. The incidence of oxygen supplement was lower in ketorolac group (1/30) than that of fentanyl group (20/30), p<0.01. The frequency of dizziness was lower in ketorolac group (1/30) than that of fentanyl group (25/30), p<0.01. Three patients in fentanyl group complained of nausea, but none in ketorolac group. The discharge time from PAR was significantly shorter in ketorolac group (13.78.4 min) than that of fentanyl group (49.514.6 min), p<0.01. CONCLUSIONS: Both intravenous ketorolac and fentanyl could provide good analgesia for ESWL. However, ketorolac demonstrated less side effects and shorter discharge time from PAR.EFFECTS OF A SINGLE DOSE OF ACETYLSALICYLIC ACID ON SORE THROAT PAIN, AND OTHER PAIN SYMPTOMS, ASSOCIATED WITH ACUTE UPPER RESPIRATORY TRACT INFECTION R. Eccles, L. Nyman, I. Loose, Common Cold Centre, Cardiff University, Cardiff, United Kingdom , Quintiles AB, Quintiles, Uppsala, Sweden , Consumer Care, Bayer AG, Leverkusen, GermanyAIM OF INVESTIGATION: Acetylsalicylic acid (ASA) has a long tradition in the treatment of symptoms of acute upper respiratory tract infection (URTI) yet modern clinical trials data is sparse for this indication. This study investigates the efficacy and safety of a single dose of 800mg ASA on treatment of pain symptoms associated with URTI. METHODS: A double blind, placebo controlled, parallel group design. Patients with sore throat pain associated with URTI were recruited at two centres. They were treated with either two effervescent tablets of ASA 400mg in water or matched placebo tablets. Primary study objective was sum of sore throat pain intensity differences (SPID) for 0-2hours. Pain and pain relief scores were made during a two hour in patient phase and continued for secondary objectives during a four hours home phase. RESULTS: 272 of 279 patients fulfilled all protocol requirements. ASA was found to be superior to placebo for SPID 0-2hours (p < 0.0001). It was also superior to placebo in the reduction in sore throat pain intensity, and relief of sore throat pain for 2,4 and 6 hours (p < 0.002); reduction in intensity of pain associated with headache (p < 0.002), and muscle aches and pains (p < 0.02) at 2 hours. No safety problems were encountered. CONCLUSIONS: Treatment with ASA has been shown to provide relief from sore throat pain, headache, and muscle aches and pains associated with URTI. ACKNOWLEDGEMENTS: This study was sponsored by Bayer AG, Germany.SAFETY AND EFFICACY OF REPEATED DOSES OF DEXKETOPROFEN TROMETAMOL I.V. IN THE MANAGEMENT OF POST-ORTHOPAEDIC SURGICAL PAIN H. Zippel, R. Artigas, M. Bertolotti, A. Capriati, M. Ballarin, Abteilung Orthopdie, Humboldt, Universitt Charit, Berlin, Germany , Clinical Research, Menarini Ricerche S.p.A., Florence, ItalyAim of investigation: To evaluate the safety and analgesic efficacy of repeated I.V. administrations of dexketoprofen trometamol (DKP.TRIS) in patients following major orthopaedic surgery. Methods: A total of 252 pts, presenting with moderate-severe pain within 12 h post recovery from general anaesthesia after hip or knee replacement surgery, were randomised to receive DKP.TRIS 50 mg or to ketoprofen (KP) 100 mg (100 ml infusion over 30 min every 8 h for two days). Rescue medication included paracetamol or morphine; PCA was not allowed. The primary end-point for efficacy was pain intensity reduction measured by SAPID0-8h. Safety was evaluated by monitoring lab parameters and AEs. Results: The study population encompassed 60% M; the mean age was 60 y; 70% undergoing hip replacement. Baseline pain intensity was scored as severe (mean VAS=75 mm). A marked pain relief was obtained following the first dose of both DKP.TRIS and KP (SAPID0-8h=311 and 326 mm.h); pain remained controlled during the study period (mean PID after 8h from start of each dose administration=43 and 47 mm). As expected, rescue medication was taken by the majority of pts, with no overt difference between DKP.TRIS and KP (81% vs 87%). A good safety profile was observed with 16% and 21% pts reporting ADRs in DKP.TRIS and KP groups, respectively. The rate of AEs, including bleeding, did not differ in pts treated with heparin or low molecular weigh heparin for the prophyilaxis of thrombo-embolic complication. Conclusion: DKP-TRIS given as 50 mg I.V. t.i.d. was safe and efficient in the management of severe post-orthopaedic pain. Acknowledgments: Supported by grants from Menarini Ricerche S.p.A.DEXKETOPROFEN TROMETAMOL VERSUS TRAMADOL IN THE RELIEF OF PAIN FOLLOWING MAJOR ORTHOPAEDIC SURGERY S. Peat, I. Paredes, A. Capriati, Dept. of Anaesthetics, King’s College Hospital, London, United Kingdom , Clinical Research, Menarini Ricerche S.p.A., Florence, ItalyAim of investigation: To evaluate the efficacy and safety of dexketoprofen trometamol (DKT.TRIS) versus tramadol (T) in the control of pain following major orthopaedic surgery. Methods: 215 M and F patients (age 18-75) undergoing primary hip or knee replacement were randomised to receive 50 mg DKP.TRIS (over 30 min), 100 mg T (bolus) or placebo (P) given I.V. according to a double blind, double-dummy design. All pts also received I.V. morphine (M) via a PCA system. A first dose of study medication was given 30 min prior to the estimated ’waking time’ (first response to verbal command); a second dose was given 6 h later. M usage, pain intensity (rated by the patient using a VAS), nausea and sedation were regularly assessed up to 12 h post dose. Results: The population had a mean age of 60 y; M/F=50%; 80% underwent hip replacement. A clear and statistically significant reduction in mean M usage was obtained after DKP.TRIS and T vs P (meanSD=1.71.0 and 1.60.8 vs 2.21.0 mg/h, respectively). Pain was well controlled (VAS<30) within the first 4, 6 and 10 h after DKP.TRIS, T and P respectively, with DKP.TRIS group obtaining the lowest pain scores from 2-12 h and less sedation than T group (77.8% vs 85.3%, ns). No difference in the overall AE profile, including nausea, was evident between treatments. Conclusion: DKP.TRIS demonstrated a significant M sparing effect when used for the control of pain following major joint surgery. In combination with PCA M, a trend of superiority of DKP.TRIS vs T was observed in terms of time to obtain pain control as well as overall analgesic effect, with a lower degree of sedation. Acknowledgments: Supported by grants from Menarini Ricerche S.p.A.ANTI-INFLAMMATORY EFFECTS OF CELECOXIB AFTER INFERIOR INCLUDED THIRD MOLAR SURGERY .P. Posso, J.O. Arantes, G. Neder, V.M. Medicine, Universidade de So Paulo, Sгo Paulo, BrazilAim of investigation: To study the anti-inflammatory effect of COX2 inhibitor celecoxib. Methods: It was evaluated 15 patients that had their inferior bilateral included third molar removed, one at a time (30 surgeries). Celecoxib or placebo were given to patients 3 hours before surgery. Group 1 received celecoxib before surgery and placebo right after it and group 2 had placebo before surgery and celecoxib right after it. Dipyrone was the rescue drug. The inflammation was evaluated by the mouth open measure between the incisal zone of superior and inferior incisors teeth. There were taken four measures: before surgery, right after, 24 and 48 hours after it. Results: Before surgery the open mouth measure average to group 1 was 50.875.40 and to the group 2 was 50.624.20. Right after surgery the open mouth measure average to group 1 was 49.064.83 and to the group 2 was 49.125.11. 24 h after surgery the open mouth measure average to group 1 was 38.3514.21 and to the group 2 was 39.4312.98 and 48h after surgery the open mouth measure average to group 1 was 41.7812.84 and to the group 2 was 40.0312.95. There were no statistic relevant values in this study. Conclusions: The use of celecoxib before inferior included third molar surgery does not change the inflammatory patterns. Acknowledgments: Supported by FAPESP.OPIOID-SPARING EFFECT OF ROFECOXIB COMPARED WITH DICLOFENAC IN ACUTE PAIN: A RANDOMIZED CONTROLLED TRIAL D.J. Chang, E. Chen, A.B. Polis, M. McAvoy, S.H. Mockoviak, G.P. Geba Clinical Development, Merck & Co., Inc., West Pont, PA , Clinical Site Operations, SCIREX Corporation, Austin, TXAim of Investigation: To compare the opioid-sparing effect of rofecoxib and diclofenac in acute pain over 24 hours. Methods: Patients experiencing moderate to severe pain after 3rd molar surgery were randomized to rofecoxib 50 mg (1 dose), diclofenac sodium 50 mg q8 hours (3 doses), or placebo. Use of opioid rescue medication (hydrocodone/acetaminophen 5/500 mg) was recorded. Patients also rated their pain and global assessments throughout 24 hours. Results: 305 patients were randomized to rofecoxib (N=121), diclofenac (N=121), or placebo (N=63). Fewer patients treated with a dose of rofecoxib required opioid medication than patients treated with a dose of diclofenac during 8 hours (19.8% vs 66.9%) and 3 doses of diclofenac during 24 hours (28.9% vs 76.0%). On average, rofecoxib patients required less opioid tablets than diclofenac patients during 8 hours (0.3 vs 1.0 per patient) and 24 hours (0.7 vs 1.9 per patient). Rofecoxib provided greater overall pain relief and patient global assessment scores than diclofenac over 8 and 24 hours. Rofecoxib patients achieved greater maximum analgesic effect, more rapid onset (31 minutes), and longer analgesic duration (>24 hours) than diclofenac patients. For all endpoints, the differences were significant (P<0.001). Conclusion: Compared with diclofenac sodium 50 mgeither 1 dose over 8 hours or 3 doses over 24 hoursa single dose of rofecoxib 50 mg demonstrated a significant reduction in opioid use and provided greater analgesic efficacy.Acknowledgement: Supported by Merck & Co., Inc. Authors Chang, Chen, Polis, McAvoy, Mockoviak, and Geba are employees of Merck & Co., IncEFFICACY AND SAFETY OF A SINGLE DOSE OF IV PARECOXIB SODIUM (PARE) FOLLOWED BY UP TO SEVEN DAYS OF ORAL VALDECOXIB (VALDE) FOR PAIN FOLLOWING LAPAROSCOPIC CHOLECYSTECTOMY H. Minkowitz, T.J. Gan, R. Cheung, R. Hubbard, C. Chen, J.G. Fort, Dept of Anes, Memorial City Hospital, Houston, TX , 2 Dept of Anes, University of Texas Southwest MCC, Dallas, TX , Dept of Anes, Duke University Medical Center, Durham, NC , 4 Global Medical Affairs, Pharmacia, Peapack, NJ , R&D, Pharmacia, Skokie, IL , 6 Global Health Outcomes, Pharmacia, Skokie, ILAim of Investigation: To evaluate a single preop dose of pare 40mg iv and postop oral valde 40 mg QD. Methods: In this randomized, d-b, p-c trial pts received standard of care, fentanyl PRN in immediate postop period and APAP 500 mg/hydrocodone 5 mg po Q4-6H PRN following discharge for up to 7 days. The active arm also received pare 40mg iv 3045 min preop and valde 40mg QD po from 6-12h after surgery, for up to 7 days. ’Worst Pain’ was evaluated daily using a modified Brief Pain Inventory (mBPI). Results: In immediate postop period (4H), pare pts (n=119) required significantly lower amounts of fentanyl (152.8g vs 192.9g: p=0.011) than comparator (n=104). Signif. fewer valde pts required supplemental analgesia over Days 1-5 postsurgery (p<0.02). Worst pain scores were also statistically signif. improved in valde group vs placebo. % pts reporting worst pain as none or mild (NRS4) in the valde and placebo group on Day 1 was 63.1% vs 29.2% (p<0.001); Day 2 69.2% vs 56.0% (p<0.02). Adverse events were comparable between groups. Conclusions: Preop pare 40mg iv resulted in signif. opioid-sparing immediately following lap chole surgery. Valde 40mg QD provided signift opioid-sparing effects and reduced worst pain levels in these pts following discharge. Both pare and valde were well tolerated. Disclosure: Sponsored by Pharmacia and Pfizer Inc.TREATMENT OF CHRONIC LOW BACK PAIN WITH ETORICOXIB, A NEW CYCLO-OXYGENASE-2 SELECTIVE INHIBITOR: A 3 MONTH PLACEBO-CONTROLLED TRIAL. G.P. Geba, J. Adler E. Quaidoo4 R. Lipetz, R. Pallay, C. Skalky, K. O’Brien, N. Bohidar, Merck & Co., Inc., West Point, PA , Health First Medical Group, Fort Worth, TX , Clinicos, Colorado Springs, CO , AAIR Research Center, Rochester, NY , Encompass Clinical Research, Spring Valley, CA , Robert Wood Johnson, Belle Mead, NJAim of Investigation: To evaluate the efficacy of etoricoxib (ETO) 60 mg and 90 mg for treatment of chronic low back pain (LBP). Methods: The 325 patients received daily ETO 60 mg (n=109) or 90
https://diarynote.indered.space
コメント