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Experimental Human and Clinical Pain Models - A Mapping Review of Standardised Methods for Clinical Evaluation of Analgesic Drugs
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| Author:
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, MALEHA BUTUL
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| Abstract:
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Effective evaluation of analgesic drugs requires robust experimental human and clinical pain-models. Despite advancements, challenges persist in translating preclinical findings into effective clinical pain management. This review explores standardized methodologies used in analgesic trials, focusing on pain models, trial designs, efficacy, endpoints and safety considerations as per regulatory requirements. A comprehensive literature search was conducted after approval from institutional ethics committee across databases including PubMed, Scopus, Embase, and Google scholar for studies and reviews related to human and clinical pain models in analgesic trials upto December 2024. Additional studies were identified through reference search of identified studies. Boolean search terms like experimental human AND clinical pain models were used in a search of titles and abstracts. No restrictions for the language or study design were kept. Articles detailing experimental and clinical pain models, trial designs, endpoints and assessment methods were analyzed. In addition, pain models in special populations were analyzed. Acute and chronic pain models were identified, with most trials employing randomized, double-blind, placebo-controlled designs. This review explored the commonly used primary efficacy endpoints and safety monitoring protocols, ethical considerations particularly emphasized in vulnerable populations such as the elderly, children, and pregnant women. Notable gaps were observed in methodology consistency and long term safety data. Therefore standardizing pain assessment methods and enhancing safety monitoring practices become crucial for improving the evaluation and development of analgesic drugs.
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| Keyword:
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Healthy Volunteers, Pain Scales, Rescue Medications, Patient Reported Outcomes, Quality of Life Questionnaires
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| EOI:
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-
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| DOI:
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https://doi.org/10.31838/ijpr/2025.17.02.002
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| Download:
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Request For Article
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