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1. DEX-2-TKA-DEXamethasone twice for pain treatment after Total Knee Arthroplasty: A protocol for a randomized, blinded, three-group multicentre clinical trial

Author

Troels Haxholdt Lunn, Stig Brorson, Kasper Smidt Gasbjerg, Peter Lindholm, Jens Bagger, Ole Mathiesen, Henrik Morville Schrøder, Niels Anker Pedersen, Janus Christian Jakobsen, Kasper Højgaard Thybo, Daniel Hägi-Pedersen, and Søren Overgaard

Subjects
Analgesic, Placebo, Dexamethasone, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Clinical Protocols, 030202 anesthesiology, law, medicine, Humans, Arthroplasty, Replacement, Knee, Pain, Postoperative, business.industry, 030208 emergency & critical care medicine, General Medicine, Perioperative, Clinical trial, Regimen, Anesthesiology and Pain Medicine, Opioid, Anesthesia, business, Methadone, medicine.drug
Abstract

BACKGROUND: Multimodal analgesia is considered the leading principle for post-operative pain treatment, but no gold standard after total knee arthroplasty (TKA) exists.AIM: To investigate the beneficial and harmful effects of one or two doses of 24 mg intravenous dexamethasone (DXM) as part of a multimodal analgesic regimen (paracetamol, NSAID and perioperative local infiltration analgesia) after TKA. We hypothesize that addition of DXM will reduce post-operative opioid consumption.METHODS: DEXamethasone twice for pain treatment after TKA is a randomized, blinded, three-group multicentre clinical trial. Participants will be randomized to one of three groups: placebo, single dose of DXM or two consecutive doses of DXM. Participants, treatment providers and investigators will be blinded to the allocated intervention. The primary outcome is total opioid consumption (units of morphine equivalents) 0-48 hours post-operatively.INCLUSION CRITERIA: unilateral, primary TKA; age ≥18 years; American Society of Anesthesiologists-Score 1-3; Body Mass Index ≥18 and ≤40; for women-not pregnant; and written informed consent.EXCLUSION CRITERIA: allergy or contraindications against trial medication; daily use of high dose opioid and/or use of methadone/transdermal opioids; daily use of systemic glucocorticoids; dysregulated diabetes; and patients suffering from alcohol and/or drug abuse. Four-hundred-and-eighty-six eligible participants are needed to detect or discard a difference of 10 mg morphine equivalents 0-48 hours post-operatively maintaining a familywise error rate of 0.05 and a power of 90% for the three possible pairwise comparisons.DISCUSSION: Recruiting is planned to commence September 2018 and expected to finish March 2020.TRIAL REGISTRATION: EudraCT: 2018-001099-39 (08/06-18); ClinicalTrials.gov: NCT03506789 (24/04-2019). Editorial Comment This is the protocol for the largest randomized clinical trial investigating the effect of one or two doses of dexamethasones on pain treatment after total knee arthroplasty. Due to the pragmatic and rigerous design this study will deliver results of high quality and external validity.

Published
2019
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2. Benefits and harm of paracetamol and ibuprofen in combination for post-operative pain: Pre-planned subgroup analyses of the multicenter, randomized PANSAID trial

Author

Kasper Højgaard Thybo, Jørgen B. Dahl, Karina Jakobsen, Louise Ibsen, Hans Henrik Bülow, Ole Mathiesen, Niels Anker Pedersen, Daniel Hägi-Pedersen, Jørn Wetterslev, Søren Overgaard, and Janus Christian Jakobsen

Subjects
Male, medicine.medical_specialty, Population, Analgesic, Psychological intervention, Subgroup analysis, Ibuprofen, Internal medicine, medicine, Humans, Adverse effect, education, Acetaminophen, Aged, Aged, 80 and over, education.field_of_study, Pain, Postoperative, Morphine, business.industry, organic chemicals, General Medicine, Middle Aged, Regimen, Anesthesiology and Pain Medicine, Drug Therapy, Combination, Female, business, medicine.drug
Abstract

Background: The “Paracetamol and Ibuprofen in Combination” (PANSAID) trial showed that combining paracetamol and ibuprofen resulted in lower opioid consumption than each drug alone and we did not find an increase in risk of harm when using ibuprofen vs paracetamol. The aim of this subgroup analysis was to investigate the differences in benefits and harms of the interventions in different subgroups. We hypothesized that the intervention effects would differ in subgroups with different risk of pain or adverse events. Methods: In these pre-planned subgroup analyses of the PANSAID trial population, we assessed subgroup heterogeneity in intervention effects between (a) subgroups (sex, age, use of analgesics, American Society of Anesthesiologists (ASA) score, and type of anesthesia) and morphine consumption, and (b) subgroups (sex, age, use of non-steroidal anti-inflammatory drugs (NSAIDs), and ASA score) and serious adverse events. Results: Test of interaction between age and the pairwise comparison between paracetamol 1 g vs paracetamol 0.5 g + ibuprofen 200 mg (P =.009) suggested lower morphine consumption in patients >65 years. However, post hoc analyses of related outcomes showed no interaction for this pairwise comparison. All other tests of interaction regarding both benefit and harm were not statistically significant. Conclusion: These pre-planned subgroup analyses did not suggest that patients in the investigated subgroups benefitted differently from a basic non-opioid analgesic regimen consisting of paracetamol and ibuprofen. Further, there was no evidence of subgroup heterogeneity regarding harm and use of ibuprofen. Because of reduced statistical power in subgroup analyses, we cannot exclude clinically relevant subgroup heterogeneity.

Published
2019
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3. Effect of Combination of Paracetamol (Acetaminophen) and Ibuprofen vs Either Alone on Patient-Controlled Morphine Consumption in the First 24 Hours After Total Hip Arthroplasty: The PANSAID Randomized Clinical Trial

Author

Kasper Højgaard Thybo, Ole Mathiesen, Rune Frederiksen, Henrik Morville Schrøder, Jan Gottfrid Bjørck, Kamilla Skovmand, Mariam Nersesjan, Daniel Hägi-Pedersen, Jørn Wetterslev, Janus Christian Jakobsen, Laura Smedegaard Kruuse, Morten Buus-Nielsen, Niels Anker Pedersen, Charlotte Voss Sørensen, Harald Schmidt, Søren Overgaard, Peter Lindholm, and Jørgen B. Dahl

Subjects
Male, Pain, Postoperative/drug therapy, medicine.medical_treatment, Arthroplasty, Replacement, Hip, Administration, Oral, Ibuprofen, Placebo, 01 natural sciences, law.invention, Ibuprofen/administration & dosage, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Double-Blind Method, law, Acetaminophen/administration & dosage, Statistical significance, medicine, Humans, 030212 general & internal medicine, Analgesics, Non-Narcotic/administration & dosage, 0101 mathematics, Adverse effect, Acetaminophen, Aged, Pain Measurement, Original Investigation, Pain, Postoperative, Analgesics, Opioid/administration & dosage, Morphine, business.industry, organic chemicals, 010102 general mathematics, General Medicine, Analgesics, Non-Narcotic, Middle Aged, Arthroplasty, Analgesics, Opioid, Arthroplasty, Replacement, Hip/adverse effects, Morphine/administration & dosage, Anesthesia, Drug Therapy, Combination, Female, business, medicine.drug
Abstract

Importance: Multimodal postoperative analgesia is widely used but lacks evidence of benefit.Objective: Investigate beneficial and harmful effects of 4 nonopioid analgesics regimens.Design, Setting, and Participants: Randomized, blinded, placebo-controlled, 4-group trial in 6 Danish hospitals with 90-day follow-up that included 556 patients undergoing total hip arthroplasty (THA) from December 2015 to October 2017. Final date of follow-up was January 1, 2018.Interventions: Participants were randomized to receive paracetamol (acetaminophen) 1000 mg plus ibuprofen 400 mg (n = 136; PCM + IBU), paracetamol 1000 mg plus matched placebo (n = 142; PCM), ibuprofen 400 mg plus matched placebo (n = 141; IBU), or half-strength paracetamol 500 mg plus ibuprofen 200 mg (n = 140; HS-PCM + IBU) orally every 6 hours for 24 hours postoperatively, starting 1 hour before surgery.Main Outcomes and Measures: Two co-primary outcomes: 24-hour morphine consumption using patient-controlled analgesia in pairwise comparisons between the 4 groups (multiplicity-adjusted thresholds for statistical significance, P Results: Among 559 randomized participants (mean age, 67 years; 277 [50%] women), 556 (99.5%) completed the trial and were included in the analysis. Median 24-hour morphine consumption was 20 mg (99.6% CI, 0-148) in the PCM + IBU group, 36 mg (99.6% CI, 0-166) for PCM alone, 26 mg (99.6% CI, 2-139) for IBU alone, and 28 mg (99.6% CI, 2-145) for HS-PCM + IBU. The median difference in morphine consumption between the PCM + IBU group vs PCM alone was 16 mg (99.6% CI, 6.5 to 24; P Conclusions and Relevance: Among patients undergoing THA, paracetamol plus ibuprofen significantly reduced morphine consumption compared with paracetamol alone in the first 24 hours after surgery; there was no statistically significant increase in SAEs in the pooled groups receiving ibuprofen alone vs with paracetamol alone. However, the combination did not result in a clinically important improvement over ibuprofen alone, suggesting that ibuprofen alone may be a reasonable option for early postoperative oral analgesia.Trial Registration: ClinicalTrials.gov Identifier: NCT02571361.

Published
2019
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4. PATIENT SAFETY, PRACTICE MANAGEMENT

Author

Nitin Sethi, Cabello Laura, Luca Ghislanzoni, S. Lindgren, Kazumi Ono, Say-Yang Ong, Pavel Rylov, Deivis Edward Marín Ríos, Agustín Viña, Belgin Yavascaoglu, Jose Andres Calvache España, Michal Tichy, Juan Carlos Bianco, Ikeda shigemasa, Jorge Luis Torrejón Rojas, Roberto Favaloro, Niels Anker Pedersen, Diana Finkel, Marcos Pacheco, Wimonrat Sriraj, Albert Lorena, Andreas Harsten, Pavel Daniljuk, Hulya Gunay, Sylviana Barsoum, Chiharu Tanaka, Karsten Skovgaard Olsen, Thomas Rahlfs, Claudia Fuxman, Lino L Gomes, Lisa Cunningham, Yusuke Koyama, Maria Cristina Almeida, Juan Ochoa, A. A. J. van Zundert, Juan Camilo Gómez Salgado, Farnaz Kamali, Teresa Verdu, Kappei Matsumoto, Baldassare Licata, Sirirat Rattana-arpa, Luis Felipe Montoya-Pelaez, A. L. Polenov, Angela María Ríos Medina, Sara Whynot, Diego Alvarez, Marcelo T. O. Carlucci, Fatma Nur Kaya, Isaak Dimitriadis, Xavier Santiveri, Dora Zuker, Udom Kachintorn, Kailash Chandra Pant, Jorge Negroni, Carlos Fava, Akihiro Kashiwai, Jonas Åkeson, Dae Ja Um, Steven R Hofstetter, Ioanis Xarikopoulos, Desigen Reddy, Gonzalo Valencia, Prabhat K Singh, Alejandro Bertolotti, Antoine Bahati Kabeza, Bindiya Hari, Mkhululi Lukhele, Petros Stefanidis, John Semple, Sanjay Gandhi, Rodriguez Consuelo, Celina Gomes, Jong Tak Park, Allen Finley Somboon, Maria Prodromiti, Surendra Singh, Chiew Kim Ng, Alejandro Leites, Takashi Nakamura, Usharani Nimmagadda, Antonio Ribo, Gustavo Lev, Julie Mathew, Sigrid Kessler, Si Gon Kim, Pasi Lahtinen, Jerry Tan, Yumi Hoshino, Giovani Locks, Sabrina Bent, Carmen Ingrassia De Cruzado, Maria Negron-Gonzalez, Frank Rosinia, Igor Idov, Nikita Trembach, Sean Gallagher, Celina Oliveira, Claudia Marquez Simões, Silvia Miller, Sumita Bery, Wiyada Chalayonnawin, Srirat Arunratanakul, Corina Lee, Natalia Lesteva, Martin Hartín Harguindeguy, Javier Garcia-Cayuela, Thrinadha Rao Polamarasetti, as Carlos Vargas, Richard Urman, Laurie Freyder, Somchai Amornyotin, Volker Lischke, Pintor Elena, Ricardo Marenchino, Andreas Pikwer, Katharina Brandner, Lieke Muntinga, Gabriel Azevedo Terra Cunha, Ellen Iannoli, Pablo Gorosito, Kim Escher, Karen Pastorio, Christian Mukwesi, Jennifer Weller, Puttachard Saengtawan, Mohamed A. Abdullah, Carla Fernandes, Filomena Cerejo, Charles Cowles, Noah Rosenberg, Guillermo Andres Tajtelbaum, Angela Truong, Ana Agrelo, David Stansfield, León Valdivieso, Ramiro Barolo, Serene Chang, Siriporn Kongphlay, Federica Lovisari, Akarin Nimmannit, Finn M. Radtke, Kim Hae, Junko Hirashima, Felipe Melo Benevides, Yanina Arzani, Dimitris Maliamanis, Wolf Brockhaus, Vitaly Novikov, Srinivas Combiatore, Fernando de Paiva Araújo, Tong Khee Tan, Jiri Lastuvka, Karina Rando, Nikolaos Noulas, Tadeusz Musialowicz, Devendra Gupta, Thienthong Pulsuk, Bangaru Reddiyar, Semiha Uzunalioglu, Martin Franck, Bernd Chr. Frankenberger, P. Jason Toppin, Somi Ramachary Desikan, Gonzalo M. Rivas, Siritda Chatrattanakulchai, Massimo Dal Bianco, Jayashree Sood, George Djaiani, Eva Bendova, Elif Copuroglu, Eric Arisi, Roser Terradas, Florencia Werhum, Tammo Brouwer, Seetharaman Hariharan, Raminder Sehgal, Diego Garcia Picasso, Allen Holmes, Siripul Raza Abidi, Kenneth Sapire, Patricia Livingston, Suan-Ling Lim, Kyuyong Jang, Silvia Niveyro, Voravut Laphisetpun, Srini Pyati, Louise Rovsing, Natascha Ghadiali, Eun Sung, Busisiwe Mrara, Dimitrios Maliamanis, Jung Kim, John Stenglein, Carmen Gómez, Carla Farré, Irina Savvina, Elisavet Karkala, Arun Krishnamurthy, Mario Parreño Caparros, Francesco Carli, Yong Sup Shin, Hidekuni Hidaka, Raquel Santos, Ihab Labbene, Filomena Farinha, John Lefante, Aneesh Srivastava, Kumkoon Wajanawichajirb, Elif Basagan-Mogol, Amreeta Yanamandra, Khoubaib Abdellatif, Fiona Murray, Jane Torrie, Sergio Candiotto, Vivian Grünzig, Lauren Zolpys, Elizabeth Rebello, Marta Garcia Orellana, Jaime Olivares, Christine Hunter, Daniel Absi, Sohini Mitra, M. Ramez Salem, Oscar David Aguirre Ospina, Yara Marcondes Machado Castiglia, Vicente Cesáreo, Luz María Gómez Buitrago, June Goh, Hyun Kyo Lim, Alejandro Javier Bernasconi, Seiji Hattori, Bernd Scheller, Carlos Alberto Fernández Muñoz, Natalia Navarro Garcia, T. Mpourtzinakos, Leandro Gobbo Braz, Ahed Zeidan, Pei-Fen Teoh, Kavi Rampersad, Sujeet K Gautam, Maycor Da Luz, Arzu Yildirim, Alberto Domenech, Christian Byhahn, Florencia Picaroni, Fred Shapiro, Shaul Cohen, Dmitry Gulaev, Jean Kronberg, Gurkan Turker, Manu-Priya Sharma, Belgin Yavaçcaoglu, Alberto Vieira Pantoja, Eman Awad, Maria Fezza, Mauro Signorelli, Fabiane Cardia Salman, Ruchi Verma, Sultan Al-Temyat, Stefano Merigliano, Karima Taamallah, Kazuhito Kusudo, Anil K. Agarwal, Mikko Hippeläinen, Isabeau Walker, Oscar Mendiz, Dariush Abtahi, Hedi Gharsallah, Fernanda Marques Ferraz de Sa, Ian Mc Lean, Pablo Ingelmo, Maurício Ceccon, Jana Janco, Evan G. Pivalizza, Ming-Li Kong, Eduardo Bilesio, Adam Snyman, Nikolaos Panagopoulos, Pamela J. Morgan, Masoumeh Heydari Farzan, Jin Young Chon, Otto Pitkänen, Guillermo Orce, Jin Lee Dong, Enis Donizetti Silva, Alamo Francisco, Afroditi Kouvalakidou, Stephanie Russo, Theogene Twagirumugabe, Imen Naas, Smita Gosavi, Robert Henderson, Antti Valtola, Tsutomu Oshima, Dam-Thuy Truong, Gabriel Canale, Joseph Ruiz, Anderson, John Denny, Daniela Fontes, Daniel Bracco, Michael Friedman, Evelin Mejía Escobar, Nisval de Magalhães Junior, Marco Antonio Cardoso de Resende, Davy Cheng, Arunotai Siriussawakul, Cor J. Kalkman, Lídia Raquel de Carvalho, Maureen Fitzpatrick, Paul Kessler, Theoneste Mwumvaneza, Jesper Troensegaard Petersen, Janet Martin, Gina Bledsoe, Deryk Chen, Ravi Saibaba, Aleksey Tokorenko, N. Nick Knezevic, Diogo Castro, Hjörtur Hjartarson, Osiel Isaías Gutiérrez Bermúdez, Priscila Kusano, Elias Leon-Ruiz, Mike Hernandez, Sören Toksvig-Larsen, Eon Moon, Uttam Singh, Siew-Luan Toh, Francisco Gorbaran, George J. Crystal, Fernanda Barros, Liam Brannigan, and Jong Taek Park

Subjects
Patient safety, Anesthesiology and Pain Medicine, business.industry, Medicine, Practice management, Medical emergency, business, medicine.disease
Published
2012
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5. Rectal midazolam as premedicant in children: a dose response study

Author

Gertrud Andersen, Niels Anker Pedersen, Pia Stjernholm, Gun Johansson, and Peter Reinstrup

Subjects
Dose, business.industry, Sedation, Low dose, Dose Response Study, Atropine, Anesthesiology and Pain Medicine, Anesthesia, Pediatrics, Perinatology and Child Health, medicine, Midazolam, Premedication, medicine.symptom, business, medicine.drug
Abstract

Rectally administered midazolam has proved to be a reliable and acceptable way of premedicating children. In order to determine the optimal dose 80 children were randomized in a double-blind manner to receive one of four different dosages of midazolam (0.2–0.3–0.4–0.5 mg·kg−1) in combination with atropine 0.02 mg·kg−1 rectally. Observations before and after premedication showed no clinically relevant differences in ventilatory and cardiovascular parameters. Neither did the groups differ as regards acceptance of the mask or awakening from anaesthesia. Regardless of group the level of sedation was increased, but only children receiving 0.4 or 0.5 mg·kg−1 of midazolam showed an increase in the level of anxiolysis. For this reason a low dose of midazolam (0.2 mg·kg−1) can be used, except in cases where pronounced anxiolysis is required.

Published
1994
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