The impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine: a cross-sequential study protocol
BackgroundAcute and chronic pain represents an escalating public health concern, necessitating safer and more effective in-hospital management approaches, including mental health. New treatment combinations involving psycholeptics are rising, but real-world evidence is lacking.ObjectivesThe study�...
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Frontiers Media S.A.
2025-04-01
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| Series: | Frontiers in Pain Research |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fpain.2025.1500422/full |
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| author | Nicola Grignoli Nicola Grignoli Nicola Grignoli Simone Livoti Simone Livoti Angela Greco Angela Greco Michela Pironi Roberta Noseda Alessandro Ceschi Alessandro Ceschi Alessandro Ceschi Alessandro Ceschi Maria Luisa Garo Luca Gabutti Luca Gabutti |
| author_facet | Nicola Grignoli Nicola Grignoli Nicola Grignoli Simone Livoti Simone Livoti Angela Greco Angela Greco Michela Pironi Roberta Noseda Alessandro Ceschi Alessandro Ceschi Alessandro Ceschi Alessandro Ceschi Maria Luisa Garo Luca Gabutti Luca Gabutti |
| author_sort | Nicola Grignoli |
| collection | DOAJ |
| description | BackgroundAcute and chronic pain represents an escalating public health concern, necessitating safer and more effective in-hospital management approaches, including mental health. New treatment combinations involving psycholeptics are rising, but real-world evidence is lacking.ObjectivesThe study's primary objective is to evaluate the impact of combined opioid analgesics and antipsychotics in-hospital medication on pain modulation. The secondary objective is to evaluate pain management.MethodsThe cross-sequential study designed by this protocol will analyze retrospective data on 5,000 hospital admissions over four years (2019–2023) gathered from Electronic Health Records (EHR) of a multisite hospital in southern Switzerland. Eligible patients are aged 18 or older and hospitalized in an Internal Medicine ward. All patients with documented pain intensity assessment through a Visual Analogue Scale (VAS ≥ 1) will be included. Cross-sectional data on demographic and clinical variables and type of medication (opioid analgesics, antipsychotics, and selected other drugs according to the Anatomical Therapeutic Chemical classification system) will be screened at hospital admission (T1) and discharge (T2). Pain modulation will be assessed by gravity (VAS mean), intensity (VAS peak/extreme value), and pain treatment effectiveness (ΔT2-T1 VAS). Hospitalization paths (short- and long-term readmissions and total length of hospital stays) will be scrutinized as additional longitudinal indices for pain management and excluded from the cross-sectional analysis. A mixed model approach will assess VAS changes from T1 to T2. Logistic regression and regression models for count data will be used for short- and long-term readmission, respectively. Propensity score matching will be used to mitigate selection bias.DiscussionThis methodological approach combines cross-sectional and longitudinal EHR data gathering in a cross-sequential design. This integration allows for a comprehensive examination of pain modulation and management among internal medicine recipients of concomitant opioids and antipsychotic treatment, spanning both hospitalization and post-discharge periods. By leveraging EHR data, the study protocol ensures reliability and standardization while minimizing missing information. Additionally, the protocol addresses the potential limitations of observational designs.ConclusionsThis method offers a comprehensive and rigorous approach to investigating pain modulation and management in internal medicine patients receiving combined opioid analgesics and antipsychotics, with potential implications for enhancing clinical practice and healthcare resource utilization. |
| format | Article |
| id | doaj-art-20a7a341f1f646ac8bf9f83a36d7605f |
| institution | DOAJ |
| issn | 2673-561X |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Frontiers Media S.A. |
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| series | Frontiers in Pain Research |
| spelling | doaj-art-20a7a341f1f646ac8bf9f83a36d7605f2025-08-20T03:17:44ZengFrontiers Media S.A.Frontiers in Pain Research2673-561X2025-04-01610.3389/fpain.2025.15004221500422The impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine: a cross-sequential study protocolNicola Grignoli0Nicola Grignoli1Nicola Grignoli2Simone Livoti3Simone Livoti4Angela Greco5Angela Greco6Michela Pironi7Roberta Noseda8Alessandro Ceschi9Alessandro Ceschi10Alessandro Ceschi11Alessandro Ceschi12Maria Luisa Garo13Luca Gabutti14Luca Gabutti15Cantonal Sociopsychiatric Organisation, Public Health Division, Department of Health and Social Care, Repubblica e Cantone Ticino, SwitzerlandDepartment of Internal Medicine, Ente Ospedaliero Cantonale, Bellinzona, SwitzerlandFaculty of Biomedical Sciences, Family Medicine Institute, Università della Svizzera Italiana, Lugano, SwitzerlandCantonal Sociopsychiatric Organisation, Public Health Division, Department of Health and Social Care, Repubblica e Cantone Ticino, SwitzerlandDepartment of Internal Medicine, Ente Ospedaliero Cantonale, Bellinzona, SwitzerlandQuality and Patient Safety Service, Ente Ospedaliero Cantonale, Locarno, SwitzerlandFaculty of Economics, University of Tor Vergata, Rome, ItalyDivision of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, SwitzerlandDivision of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, SwitzerlandDivision of Clinical Pharmacology and Toxicology, Institute of Pharmacological Sciences of Southern Switzerland, Ente Ospedaliero Cantonale, Lugano, SwitzerlandFaculty of Biomedical Sciences, Università della Svizzera Italiana, Lugano, SwitzerlandClinical Trial Unit, Ente Ospedaliero Cantonale, Lugano, SwitzerlandDepartment of Clinical Pharmacology and Toxicology, University Hospital Zurich, Zurich, Switzerland0Biostatistics Unit, Mathsly Research, Rome, ItalyDepartment of Internal Medicine, Ente Ospedaliero Cantonale, Bellinzona, SwitzerlandFaculty of Biomedical Sciences, Family Medicine Institute, Università della Svizzera Italiana, Lugano, SwitzerlandBackgroundAcute and chronic pain represents an escalating public health concern, necessitating safer and more effective in-hospital management approaches, including mental health. New treatment combinations involving psycholeptics are rising, but real-world evidence is lacking.ObjectivesThe study's primary objective is to evaluate the impact of combined opioid analgesics and antipsychotics in-hospital medication on pain modulation. The secondary objective is to evaluate pain management.MethodsThe cross-sequential study designed by this protocol will analyze retrospective data on 5,000 hospital admissions over four years (2019–2023) gathered from Electronic Health Records (EHR) of a multisite hospital in southern Switzerland. Eligible patients are aged 18 or older and hospitalized in an Internal Medicine ward. All patients with documented pain intensity assessment through a Visual Analogue Scale (VAS ≥ 1) will be included. Cross-sectional data on demographic and clinical variables and type of medication (opioid analgesics, antipsychotics, and selected other drugs according to the Anatomical Therapeutic Chemical classification system) will be screened at hospital admission (T1) and discharge (T2). Pain modulation will be assessed by gravity (VAS mean), intensity (VAS peak/extreme value), and pain treatment effectiveness (ΔT2-T1 VAS). Hospitalization paths (short- and long-term readmissions and total length of hospital stays) will be scrutinized as additional longitudinal indices for pain management and excluded from the cross-sectional analysis. A mixed model approach will assess VAS changes from T1 to T2. Logistic regression and regression models for count data will be used for short- and long-term readmission, respectively. Propensity score matching will be used to mitigate selection bias.DiscussionThis methodological approach combines cross-sectional and longitudinal EHR data gathering in a cross-sequential design. This integration allows for a comprehensive examination of pain modulation and management among internal medicine recipients of concomitant opioids and antipsychotic treatment, spanning both hospitalization and post-discharge periods. By leveraging EHR data, the study protocol ensures reliability and standardization while minimizing missing information. Additionally, the protocol addresses the potential limitations of observational designs.ConclusionsThis method offers a comprehensive and rigorous approach to investigating pain modulation and management in internal medicine patients receiving combined opioid analgesics and antipsychotics, with potential implications for enhancing clinical practice and healthcare resource utilization.https://www.frontiersin.org/articles/10.3389/fpain.2025.1500422/fullpainmental healthopioidsantipsychoticsinternal medicinehospitalization |
| spellingShingle | Nicola Grignoli Nicola Grignoli Nicola Grignoli Simone Livoti Simone Livoti Angela Greco Angela Greco Michela Pironi Roberta Noseda Alessandro Ceschi Alessandro Ceschi Alessandro Ceschi Alessandro Ceschi Maria Luisa Garo Luca Gabutti Luca Gabutti The impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine: a cross-sequential study protocol Frontiers in Pain Research pain mental health opioids antipsychotics internal medicine hospitalization |
| title | The impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine: a cross-sequential study protocol |
| title_full | The impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine: a cross-sequential study protocol |
| title_fullStr | The impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine: a cross-sequential study protocol |
| title_full_unstemmed | The impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine: a cross-sequential study protocol |
| title_short | The impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine: a cross-sequential study protocol |
| title_sort | impact of opioid analgesics with concomitant antipsychotic use on pain modulation and management in internal medicine a cross sequential study protocol |
| topic | pain mental health opioids antipsychotics internal medicine hospitalization |
| url | https://www.frontiersin.org/articles/10.3389/fpain.2025.1500422/full |
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