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Article ; Online: Electron Kinetic Entropy across Quasi-Perpendicular Shocks.

Lindberg, Martin / Vaivads, Andris / Raptis, Savvas / Lindqvist, Per-Arne / Giles, Barbara L / Gershman, Daniel Jonathan

Entropy (Basel, Switzerland)

2022 Volume 24, Issue 6

Abstract: We use Magnetospheric Multiscale (MMS) data to study electron kinetic entropy per particle Se across Earth's quasi-perpendicular bow shock. We have selected 22 shock crossings covering a wide range of shock conditions. Measured distribution functions are ...

Abstract	We use Magnetospheric Multiscale (MMS) data to study electron kinetic entropy per particle Se across Earth's quasi-perpendicular bow shock. We have selected 22 shock crossings covering a wide range of shock conditions. Measured distribution functions are calibrated and corrected for spacecraft potential, secondary electron contamination, lack of measurements at the lowest energies and electron density measurements based on plasma frequency measurements. All crossings display an increase in electron kinetic entropy across the shock ΔSe being positive or zero within their error margin. There is a strong dependence of ΔSe on the change in electron temperature, ΔTe, and the upstream electron plasma beta, βe. Shocks with large ΔTe have large ΔSe. Shocks with smaller βe are associated with larger ΔSe. We use the values of ΔSe, ΔTe and density change Δne to determine the effective adiabatic index of electrons for each shock crossing. The average effective adiabatic index is ⟨γe⟩=1.64±0.07.
Language	English
Publishing date	2022-05-24
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2014734-X
ISSN	1099-4300 ; 1099-4300
ISSN (online)	1099-4300
ISSN	1099-4300
DOI	10.3390/e24060745
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Article ; Online: Associations of dexamethasone's effect on morphine consumption after total knee arthroplasty-Subgroup analyses.

Gasbjerg, Kasper S / Lunn, Troels H / Hägi-Pedersen, Daniel / Overgaard, Søren / Pedersen, Niels A / Lindholm, Peter / Lindberg-Larsen, Martin / Brorson, Stig / Schrøder, Henrik M / Thybo, Kasper H / Olsen, Markus H / Mathiesen, Ole / Jakobsen, Janus C

Acta anaesthesiologica Scandinavica

2024 Volume 68, Issue 4, Page(s) 546–555

Abstract: The DEXamethasone twice for pain treatment after Total Knee Arthroplasty (DEX-2-TKA) trial showed that adding one and two doses of 24 mg intravenous dexamethasone to paracetamol, ibuprofen and local infiltration analgesia, reduced morphine consumption ( ... ...

Abstract	The DEXamethasone twice for pain treatment after Total Knee Arthroplasty (DEX-2-TKA) trial showed that adding one and two doses of 24 mg intravenous dexamethasone to paracetamol, ibuprofen and local infiltration analgesia, reduced morphine consumption (primary outcome) within 48 h after TKA. We aimed to explore the differences in the effect of dexamethasone on morphine consumption in different subgroups. Quantile regression adjusted for site was used to test for significant interaction between the predefined dichotomised subgroups and treatment group. The subgroups were defined based on baseline data: sex (male/female), age (≤65 years/>65 years), American Society of Anaesthesiologists (ASA)-score (ASA I + II/III), visual analogue score of preoperative pain at rest (≤30 mm/>30 mm), pain during mobilisation (≤30 mm/>30 mm), type of anaesthesia (spinal anaesthesia/general anaesthesia and spinal converted to general anaesthesia), and prior daily use of analgesics (either paracetamol and/or NSAID/neither). These analyses were supplemented with post hoc multivariate linear regression analyses. Test of interaction comparing sex in the pairwise comparison between DX2 (dexamethasone [24 mg] + dexamethasone [24 mg]) versus placebo (p = .02), showed a larger effect of dexamethasone on morphine consumption in male patients compared to females. Test of interaction comparing age in the pairwise comparison between DX1 (dexamethasone [24 mg] + placebo) versus placebo (p = .04), showed a larger effect of dexamethasone on morphine consumption in younger patients (≤65 years) compared to older. All remaining subgroup analyses showed no evidence of a difference. The supplemental multivariate analyses did not support any significant interaction for sex (p = .256) or age (p = .730) but supported a significant interaction with the type of anaesthesia (p < .001). Our results from the quantile regression analyses indicate that the male sex and younger age (≤65 years) may be associated with a larger analgesic effect of dexamethasone than the effects in other types of patients. However, this is not supported by post-hoc multivariate linear regression analyses. The two types of analyses both supported a possible interaction with the type of anaesthesia.
MeSH term(s)	Humans ; Male ; Female ; Aged ; Morphine/therapeutic use ; Acetaminophen/therapeutic use ; Arthroplasty, Replacement, Knee ; Pain, Postoperative/drug therapy ; Dexamethasone/therapeutic use ; Analgesics, Opioid/therapeutic use ; Double-Blind Method
Chemical Substances	Morphine (76I7G6D29C) ; Acetaminophen (362O9ITL9D) ; Dexamethasone (7S5I7G3JQL) ; Analgesics, Opioid
Language	English
Publishing date	2024-01-24
Publishing country	England
Document type	Journal Article
ZDB-ID	80002-8
ISSN	1399-6576 ; 0001-5172
ISSN (online)	1399-6576
ISSN	0001-5172
DOI	10.1111/aas.14377
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Zs.A 22: Show issues

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Article ; Online: Subclinical epileptiform discharges in Alzheimer's disease are associated with increased hippocampal blood flow.

Musaeus, Christian Sandøe / Kjaer, Troels Wesenberg / Lindberg, Ulrich / Vestergaard, Mark B / Bo, Henrik / Larsson, Wiberg / Press, Daniel Zvi / Andersen, Birgitte Bo / Høgh, Peter / Kidmose, Preben / Hemmsen, Martin Christian / Rank, Mike Lind / Hasselbalch, Steen Gregers / Waldemar, Gunhild / Frederiksen, Kristian Steen

Alzheimer's research & therapy

2024 Volume 16, Issue 1, Page(s) 80

Abstract: Background: In epilepsy, the ictal phase leads to cerebral hyperperfusion while hypoperfusion is present in the interictal phases. Patients with Alzheimer's disease (AD) have an increased prevalence of epileptiform discharges and a study using ... ...

Abstract	Background: In epilepsy, the ictal phase leads to cerebral hyperperfusion while hypoperfusion is present in the interictal phases. Patients with Alzheimer's disease (AD) have an increased prevalence of epileptiform discharges and a study using intracranial electrodes have shown that these are very frequent in the hippocampus. However, it is not known whether there is an association between hippocampal hyperexcitability and regional cerebral blood flow (rCBF). The objective of the study was to investigate the association between rCBF in hippocampus and epileptiform discharges as measured with ear-EEG in patients with Alzheimer's disease. Our hypothesis was that increased spike frequency may be associated with increased rCBF in hippocampus. Methods: A total of 24 patients with AD, and 15 HC were included in the analysis. Using linear regression, we investigated the association between rCBF as measured with arterial spin-labelling MRI (ASL-MRI) in the hippocampus and the number of spikes/sharp waves per 24 h as assessed by ear-EEG. Results: No significant difference in hippocampal rCBF was found between AD and HC (p-value = 0.367). A significant linear association between spike frequency and normalized rCBF in the hippocampus was found for patients with AD (estimate: 0.109, t-value = 4.03, p-value < 0.001). Changes in areas that typically show group differences (temporal-parietal cortex) were found in patients with AD, compared to HC. Conclusions: Increased spike frequency was accompanied by a hemodynamic response of increased blood flow in the hippocampus in patients with AD. This phenomenon has also been shown in patients with epilepsy and supports the hypothesis of hyperexcitability in patients with AD. The lack of a significant difference in hippocampal rCBF may be due to an increased frequency of epileptiform discharges in patients with AD. Trial registration: The study is registered at clinicaltrials.gov (NCT04436341).
MeSH term(s)	Humans ; Alzheimer Disease/complications ; Alzheimer Disease/diagnostic imaging ; Hippocampus/diagnostic imaging ; Temporal Lobe ; Cerebrovascular Circulation ; Epilepsy/diagnostic imaging
Language	English
Publishing date	2024-04-12
Publishing country	England
Document type	Journal Article
ZDB-ID	2506521-X
ISSN	1758-9193 ; 1758-9193
ISSN (online)	1758-9193
ISSN	1758-9193
DOI	10.1186/s13195-024-01432-9
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Article ; Online: Therapy-related MDS dissected based on primary disease and treatment-a nationwide perspective.

Moreno Berggren, Daniel / Garelius, Hege / Willner Hjelm, Petter / Nilsson, Lars / Rasmussen, Bengt / Weibull, Caroline E / Lambe, Mats / Lehmann, Sören / Hellström-Lindberg, Eva / Jädersten, Martin / Ejerblad, Elisabeth

Leukemia

2023 Volume 37, Issue 5, Page(s) 1103–1112

Abstract: In this population-based study, we aimed to characterize and compare subgroups of therapy-related Myelodysplastic syndromes (t-MDS) and define the implications of type of previous treatment and primary disease. We combined data from MDS patients, ... ...

Abstract	In this population-based study, we aimed to characterize and compare subgroups of therapy-related Myelodysplastic syndromes (t-MDS) and define the implications of type of previous treatment and primary disease. We combined data from MDS patients, diagnosed between 2009 and 2017 (n = 2705), in the nationwide Swedish MDS register, with several health registers. Furthermore, using matched population controls, we investigated the prevalence of antecedent malignancies in MDS patients in comparison with the general population. This first ever nationwide study on t-MDS confirms a shorter median survival for t-MDS compared to de novo MDS (15.8 months vs 31.1 months, p < 0.001). T-MDS patients previously treated with radiation only had disease characteristics with a striking resemblance to de novo-MDS, in sharp contrast to patients treated with chemotherapy who had a significantly higher risk profile. IPSS-R and the WHO classification differentiated t-MDS into different risk groups. As compared with controls, MDS patients had a six-fold increased prevalence of a previous hematological malignancy but only a 34% increased prevalence of a previous solid tumor. T-MDS patients with a previous hematological malignancy had a dismal prognosis, due both to mortality related to their primary disease and to high-risk MDS.
MeSH term(s)	Humans ; Leukemia, Myeloid, Acute/diagnosis ; Prognosis ; Neoplasms, Second Primary/epidemiology ; Neoplasms, Second Primary/etiology ; Neoplasms, Second Primary/diagnosis ; Risk Factors ; Hematologic Neoplasms
Language	English
Publishing date	2023-03-17
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	807030-1
ISSN	1476-5551 ; 0887-6924
ISSN (online)	1476-5551
ISSN	0887-6924
DOI	10.1038/s41375-023-01864-6
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Article ; Online: Electron Kinetic Entropy across Quasi-Perpendicular Shocks

Martin Lindberg / Andris Vaivads / Savvas Raptis / Per-Arne Lindqvist / Barbara L. Giles / Daniel Jonathan Gershman

Entropy, Vol 24, Iss 745, p

2022 Volume 745

Abstract: We use Magnetospheric Multiscale (MMS) data to study electron kinetic entropy per particle ... S ... e ... across Earth’ ...

Abstract	We use Magnetospheric Multiscale (MMS) data to study electron kinetic entropy per particle <math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><msub><mi>S</mi><mi mathvariant="normal">e</mi></msub></semantics></math> across Earth’s quasi-perpendicular bow shock. We have selected 22 shock crossings covering a wide range of shock conditions. Measured distribution functions are calibrated and corrected for spacecraft potential, secondary electron contamination, lack of measurements at the lowest energies and electron density measurements based on plasma frequency measurements. All crossings display an increase in electron kinetic entropy across the shock <math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><mrow><mo>Δ</mo><msub><mi>S</mi><mi mathvariant="normal">e</mi></msub></mrow></semantics></math> being positive or zero within their error margin. There is a strong dependence of <math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><mrow><mo>Δ</mo><msub><mi>S</mi><mi mathvariant="normal">e</mi></msub></mrow></semantics></math> on the change in electron temperature, <math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><mrow><mo>Δ</mo><msub><mi>T</mi><mi mathvariant="normal">e</mi></msub></mrow></semantics></math> , and the upstream electron plasma beta, <math xmlns="http://www.w3.org/1998/Math/MathML" display="inline"><semantics><msub><mi>β</mi><mi mathvariant="normal">e</mi></msub></semantics></math> . Shocks with large <math xmlns="http://www.w3.org/1998/Math/MathML" ...<br />
Keywords	space plasma ; electron kinetic entropy ; quasi-perpendicular shock ; adiabatic index ; Science ; Q ; Astrophysics ; QB460-466 ; Physics ; QC1-999
Language	English
Publishing date	2022-05-01T00:00:00Z
Publisher	MDPI AG
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article: Adult-Onset Ataxia With Neuropathy and White Matter Abnormalities Due to a Novel

Paucar, Martin / Tesi, Bianca / Eshtad, Saeed / Eriksson, Caroline / Hashim, Farouk / Nilsson, Daniel / Pourhamidi, Kaveh / Hellström-Lindberg, Eva / Bryceson, Yenan T / Svenningsson, Per

Neurology. Genetics

2021 Volume 7, Issue 6, Page(s) e628

Language	English
Publishing date	2021-10-28
Publishing country	United States
Document type	Journal Article
ZDB-ID	2818607-2
ISSN	2376-7839
ISSN	2376-7839
DOI	10.1212/NXG.0000000000000628
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Article ; Online: Prolonged effects of dexamethasone following total knee arthroplasty: A pre-planned sub-study of the DEX-2-TKA trial.

Derby, Cecilie Bauer / Gasbjerg, Kasper Smidt / Hägi-Pedersen, Daniel / Lunn, Troels Haxholdt / Pedersen, Niels Anker / Lindholm, Peter / Brorson, Stig / Schrøder, Henrik Morville / Thybo, Kasper Højgaard / Bagger, Jens / Lindberg-Larsen, Martin / Overgaard, Søren / Jakobsen, Janus Christian / Mathiesen, Ole

Acta anaesthesiologica Scandinavica

2023 Volume 68, Issue 1, Page(s) 35–42

Abstract: Objectives: The DEX-2-TKA trial demonstrated that one and two doses of 24 mg intravenous dexamethasone reduced opioid consumption and pain after total knee arthroplasty (TKA). We aimed to investigate the prolonged effects of dexamethasone after the 48-h ...

Abstract	Objectives: The DEX-2-TKA trial demonstrated that one and two doses of 24 mg intravenous dexamethasone reduced opioid consumption and pain after total knee arthroplasty (TKA). We aimed to investigate the prolonged effects of dexamethasone after the 48-h intervention period. Design: This was a prospective, pre-planned questionnaire follow-up on postoperative days 3-7 of patients in the DEX-2-TKA trial that randomly received: DX1 (dexamethasone 24 mg + placebo), DX2 (dexamethasone 24 mg + dexamethasone 24 mg), and placebo (placebo + placebo) perioperatively and 24 h later. Setting: A multicenter trial performed at five Danish hospitals. Participants: We analyzed 434 of 485 adult participants enrolled in the DEX-2-TKA trial. Outcome measures: Primary outcome was difference between groups in average of all numerical rating scale (NRS) pain scores reported in the morning, at bedtime, and the daily average pain on postoperative days 3-7. Secondary outcomes were sleep quality and patient satisfaction. Results: The median (interquartile range) pain intensity levels for postoperative days 3-7 were: DX2 3.2 (2.1-4.3); DX1 3.3 (2.3-4.1); and placebo 3.3 (2.5-4.7). Hodges-Lehmann median differences between groups were: 0 (95% confidence interval - 0.54 to 0.2), P = 0.38 between DX1 and placebo; 0.1 (-0.47 to 0.33), p = .87 between DX1 and DX2; and 0.1 (-0.6 to 0.13), p = .20 between DX2 and placebo. We found no relevant differences between groups on sleep quality on postoperative days 3-7 nor for patient satisfaction with the analgesic treatment. Conclusions: We found that neither one nor two doses of 24 mg intravenous dexamethasone demonstrated prolonged effects on overall pain or sleep quality on postoperative days 3-7 after total knee arthroplasty. We also found that dexamethasone had no effect on patient satisfaction. Trial registration number: Clinicaltrials.gov NCT03506789 (main result trial).
MeSH term(s)	Adult ; Humans ; Arthroplasty, Replacement, Knee ; Prospective Studies ; Pain, Postoperative/drug therapy ; Analgesics, Opioid ; Dexamethasone/therapeutic use ; Double-Blind Method
Chemical Substances	Analgesics, Opioid ; Dexamethasone (7S5I7G3JQL)
Language	English
Publishing date	2023-09-14
Publishing country	England
Document type	Multicenter Study ; Journal Article
ZDB-ID	80002-8
ISSN	1399-6576 ; 0001-5172
ISSN (online)	1399-6576
ISSN	0001-5172
DOI	10.1111/aas.14319
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Article ; Online: Pain treatment after total hip arthroplasty: Detailed statistical analysis plan for the RECIPE randomised clinical trial.

Acta anaesthesiologica Scandinavica

2023 Volume 67, Issue 3, Page(s) 372–380

Abstract: Background: The RECIPE trial systematically investigates the effects of different combinations of paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty. To preserve transparency, minimise risk of bias and to prevent ... ...

Abstract	Background: The RECIPE trial systematically investigates the effects of different combinations of paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty. To preserve transparency, minimise risk of bias and to prevent data-driven analysis, we present this detailed statistical analysis plan. Methods: The RECIPE trial is a randomised, blinded, parallel four-group multicenter clinical trial for patients undergoing planned primary total hip arthroplasty. Interventions are initiated preoperatively and continued for 24 h postoperatively. Primary outcome is total opioid consumption 0-24 h after end of surgery. Primary analysis will be performed in the modified intention to treat population of all patients undergoing total hip arthroplasty, and all analyses will be stratified for site. We will perform pairwise comparisons between each of the four groups. The primary outcome will be analysed using the van Elteren test and we will present Hodges-Lehmann median differences and confidence intervals. Binary outcomes will be analysed using logistic regression. To preserve a family-wise error rate of <0.05, we will use a Bonferroni-adjusted alfa of 0.05/6 = 0.0083 for all six pairwise comparisons between groups when analysing the primary outcome. We will systematically assess the underlying statistical assumptions for each analysis. Data will be analysed by two blinded independent statisticians, and we will write abstracts covering all possible combinations of conclusions, before breaking the blind. Discussion: The RECIPE trial will provide important information on benefit and harm of combinations of the most frequently used non-opioid analgesics for pain after primary hip arthroplasty.
MeSH term(s)	Humans ; Arthroplasty, Replacement, Hip ; Pain, Postoperative/drug therapy ; Pain, Postoperative/prevention & control ; Acetaminophen/therapeutic use ; Analgesics, Non-Narcotic/therapeutic use ; Ibuprofen/therapeutic use ; Analgesics, Opioid/therapeutic use
Chemical Substances	Acetaminophen (362O9ITL9D) ; Analgesics, Non-Narcotic ; Ibuprofen (WK2XYI10QM) ; Analgesics, Opioid
Language	English
Publishing date	2023-01-12
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article
ZDB-ID	80002-8
ISSN	1399-6576 ; 0001-5172
ISSN (online)	1399-6576
ISSN	0001-5172
DOI	10.1111/aas.14179
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Zs.A 22: Show issues

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Article ; Online: Non-opioid analgesic combinations following total hip arthroplasty (RECIPE): a randomised, placebo-controlled, blinded, multicentre trial.

Steiness, Joakim / Hägi-Pedersen, Daniel / Lunn, Troels Haxholdt / Overgaard, Søren / Brorson, Stig / Graungaard, Ben Kristian / Lindberg-Larsen, Martin / Varnum, Claus / Lundstrøm, Lars Hyldborg / Beck, Torben / Skettrup, Michael / Pedersen, Niels Anker / Bieder, Manuel Josef / von Cappeln, Adam Gregers / Pleckaitiene, Lina / Lindholm, Peter / Bukhari, Syed Shaheer Haider / Derby, Cecilie Bauer / Nielsen, Maria Gantzel /

Exsteen, Oskar Wilborg / Vinstrup, Louise Ørts / Thybo, Kasper Højgaard / Gasbjerg, Kasper Smidt / Nørskov, Anders Kehlet / Jakobsen, Janus Christian / Mathiesen, Ole

The Lancet. Rheumatology

2024 Volume 6, Issue 4, Page(s) e205–e215

Abstract: Background: Multimodal postoperative analgesia following total hip arthroplasty is recommended, but the optimal combination of drugs remains uncertain. The aim of the RECIPE trial was to investigate the relative benefit and harm of the different ... ...

Abstract	Background: Multimodal postoperative analgesia following total hip arthroplasty is recommended, but the optimal combination of drugs remains uncertain. The aim of the RECIPE trial was to investigate the relative benefit and harm of the different combinations of paracetamol, ibuprofen, and the analgesic adjuvant dexamethasone for treatment of postoperative pain following total hip arthroplasty. Methods: The RECIPE trial was a randomised, blinded, placebo-controlled trial conducted at nine Danish hospitals. Adults scheduled for total hip arthroplasty were randomly assigned (1:1:1:1) using a computer-generated list with stratification by site to receive combinations of oral paracetamol 1000 mg every 6 h, oral ibuprofen 400 mg every 6 h, or a single-dose of intravenous dexamethasone 24 mg in the following groups: paracetamol plus ibuprofen, ibuprofen plus dexamethasone, paracetamol plus dexamethasone, and paracetamol plus ibuprofen plus dexamethasone. The primary outcome was 24 h intravenous morphine consumption, analysed in a modified intention-to-treat population, defined as all randomly assigned participants who underwent total hip arthroplasty. The predefined minimal important difference was 8 mg. Safety outcomes included serious and non-serious adverse events within 90 days and 24 h. The trial was registered with ClinicalTrials.gov, NCT04123873. Findings: Between March 5, 2020, and Nov 15, 2022, we randomly assigned 1060 participants, of whom 1043 (589 [56%] women and 454 [44%] men) were included in the modified intention-to-treat population. 261 were assigned to paracetamol plus ibuprofen, 262 to ibuprofen plus dexamethasone, 262 to paracetamol plus dexamethasone, and 258 to paracetamol plus ibuprofen plus dexamethasone. Median 24 h morphine consumption was 24 mg (IQR 12-38) in the paracetamol plus ibuprofen group, 20 mg (12-32) in the paracetamol plus dexamethasone group, 16 mg (10-30) in the ibuprofen plus dexamethasone group, and 15 mg (8-26) in the paracetamol plus ibuprofen plus dexamethasone group. The paracetamol plus ibuprofen plus dexamethasone group had a significantly reduced 24 h morphine consumption compared with paracetamol plus ibuprofen (Hodges-Lehmann median difference -6 mg [99% CI -10 to -3]; p<0·0001) and paracetamol plus dexamethasone (-4 mg [-8 to -1]; p=0·0013), however, none of the comparisons showed differences reaching the minimal important threshold of 8 mg. 91 (35%) of 258 participants in the paracetamol plus ibuprofen plus dexamethasone group had one or more adverse events, compared with 99 (38%) of 262 in the ibuprofen plus dexamethasone group, 103 (39%) of 262 in the paracetamol plus dexamethasone group, and 165 (63%) of 261 in the paracetamol plus ibuprofen group. Interpretation: In adults undergoing total hip arthroplasty, a combination of paracetamol, ibuprofen, and dexamethasone had the lowest morphine consumption within 24 h following surgery and the most favourable adverse event profile, with a lower incidence of serious and non-serious adverse events (primarily driven by differences in nausea, vomiting, and dizziness) compared with paracetamol plus ibuprofen. Funding: The Novo Nordisk Foundation and Næstved-Slagelse-Ringsted Hospitals' Research Fund.
MeSH term(s)	Male ; Adult ; Humans ; Female ; Analgesics, Non-Narcotic/therapeutic use ; Acetaminophen/therapeutic use ; Ibuprofen/adverse effects ; Arthroplasty, Replacement, Hip/adverse effects ; Drug Therapy, Combination ; Morphine/adverse effects ; Dexamethasone/adverse effects
Chemical Substances	Analgesics, Non-Narcotic ; Acetaminophen (362O9ITL9D) ; Ibuprofen (WK2XYI10QM) ; Morphine (76I7G6D29C) ; Dexamethasone (7S5I7G3JQL)
Language	English
Publishing date	2024-03-05
Publishing country	England
Document type	Randomized Controlled Trial ; Multicenter Study ; Journal Article
ISSN	2665-9913
ISSN (online)	2665-9913
DOI	10.1016/S2665-9913(24)00020-1
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Article ; Online: Paracetamol, ibuprofen and dexamethasone for pain treatment after total hip arthroplasty: protocol for the randomised, placebo-controlled, parallel 4-group, blinded, multicentre RECIPE trial.

Steiness, Joakim / Hägi-Pedersen, Daniel / Lunn, Troels Haxholdt / Lindberg-Larsen, Martin / Graungaard, Ben Kristian / Lundstrom, Lars Hyldborg / Lindholm, Peter / Brorson, Stig / Bieder, Manuel Josef / Beck, Torben / Skettrup, Michael / von Cappeln, Adam Gregers / Thybo, Kasper Højgaard / Gasbjerg, Kasper Smidt / Overgaard, Søren / Jakobsen, Janus Christian / Mathiesen, Ole

BMJ open

2022 Volume 12, Issue 9, Page(s) e058965

Abstract: Introduction: Multimodal analgesia with paracetamol, non-steroidal anti-inflammatory drug and glucocorticoid is recommended for hip arthroplasty, but with uncertain effects of the different combinations. We aim to investigate benefit and harm of ... ...

Abstract	Introduction: Multimodal analgesia with paracetamol, non-steroidal anti-inflammatory drug and glucocorticoid is recommended for hip arthroplasty, but with uncertain effects of the different combinations. We aim to investigate benefit and harm of different combinations of paracetamol, ibuprofen and dexamethasone following total hip arthroplasty. Methods and analysis: RECIPE is a randomised, placebo-controlled, parallel 4-group, blinded trial with 90-day and 1-year follow-up performed at nine Danish hospitals. Interventions are initiated preoperatively and continued for 24 hours postoperatively. Eligible participants undergoing total hip arthroplasty are randomised to:group A: oral paracetamol 1000 mg × 4+oral ibuprofen 400 mg × 4+intravenous placebo; group B: oral paracetamol 1000 mg × 4+intravenous dexamethasone 24 mg+oral placebo; group C: oral ibuprofen 400 mg × 4+intravenous dexamethasone 24 mg+oral placebo; group D: oral paracetamol 1000 mg × 4+oral ibuprofen 400 mg × 4+intravenous dexamethasone 24 mg.Primary outcome is cumulative opioid consumption at 0-24 hours. Secondary outcomes are pain at rest, during mobilisation and during a 5 m walk and adverse events. Follow-up includes serious adverse events and patient reported outcome measures at 90 days and 1 year. A total of 1060 participants are needed to demonstrate a difference of 8 mg in 24-hour morphine consumption assuming an SD of 24.5 mg, a risk of type I errors of 0.0083 and a risk of type 2 errors of 0.2. Primary analysis will be a modified intention-to-treat analysis.With this trial we aim to verify recommendations for pain treatment after total hip arthroplasty, and investigate the role of dexamethasone as an analgesic adjuvant to paracetamol and ibuprofen. Ethics and dissemination: This trial is approved by the Region Zealand Committee on Health Research Ethics (SJ-799). Plans for dissemination include publication in peer-reviewed journals and presentation at scientific meetings. Trial registration number: NCT04123873.
MeSH term(s)	Acetaminophen/therapeutic use ; Analgesics/therapeutic use ; Analgesics, Opioid/therapeutic use ; Anti-Inflammatory Agents, Non-Steroidal ; Arthroplasty, Replacement, Hip/adverse effects ; Dexamethasone/therapeutic use ; Double-Blind Method ; Glucocorticoids/therapeutic use ; Humans ; Ibuprofen ; Morphine ; Multicenter Studies as Topic ; Pain, Postoperative/drug therapy ; Pain, Postoperative/etiology ; Randomized Controlled Trials as Topic
Chemical Substances	Analgesics ; Analgesics, Opioid ; Anti-Inflammatory Agents, Non-Steroidal ; Glucocorticoids ; Acetaminophen (362O9ITL9D) ; Morphine (76I7G6D29C) ; Dexamethasone (7S5I7G3JQL) ; Ibuprofen (WK2XYI10QM)
Language	English
Publishing date	2022-09-01
Publishing country	England
Document type	Clinical Trial Protocol ; Journal Article
ZDB-ID	2599832-8
ISSN	2044-6055 ; 2044-6055
ISSN (online)	2044-6055
ISSN	2044-6055
DOI	10.1136/bmjopen-2021-058965
Database	MEDical Literature Analysis and Retrieval System OnLINE

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