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Determining Pain Detection and Tolerance Thresholds Using an Integrated, Multi-Modal Pain Task Battery
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Minimal important difference in opioid consumption based on adverse event reduction-A study protocol.

Anders Peder Højer Karlsen1,2, Casper Pedersen1, Jens Laigaard3

  • 1Department of Anaesthesiology, Centre for Anaesthesiological Research, Zealand University Hospital, Køge, Denmark.

Acta Anaesthesiologica Scandinavica
|November 26, 2022
PubMed
Summary
This summary is machine-generated.

Determining the minimal important difference in opioid consumption is crucial for assessing clinical relevance in pain management trials. This study links opioid use to adverse effects to define this important threshold.

Keywords:
hip arthroplastyknee arthroplastyminimal important differenceopioid consumptionpostoperative pain management

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Area of Science:

  • Pain Management
  • Clinical Trials
  • Pharmacology

Background:

  • The patient-relevant minimal important difference for opioid consumption is undetermined, hindering the evaluation of clinical relevance in postoperative pain trials.
  • A minimal important difference is essential for interpreting trial results and powering future studies to detect clinically relevant effects.
  • Understanding the dose-response relationship between opioid use and adverse effects can help approximate this crucial metric.

Purpose of the Study:

  • To approximate the minimal important difference in postoperative opioid consumption.
  • To anchor this difference to opioid-related adverse effects, such as nausea, sedation, and vomiting.
  • To inform the design and interpretation of clinical trials in pain management.

Main Methods:

  • Post-hoc analysis of aggregated data from two clinical trials and one observational cohort study.
  • Primary outcome: Hodges-Lehmann median difference in opioid consumption between patients with and without mild opioid-related adverse effects.
  • Secondary outcomes: Opioid consumption corresponding to one point on an adverse event scale and proportion of patients experiencing adverse effects across opioid dose intervals.

Main Results:

  • Analysis of opioid consumption and related adverse effects to establish a patient-relevant minimal important difference.
  • Quantile regression to explore interactions with patient baseline characteristics.
  • Identification of opioid dose thresholds associated with increased risk of adverse events.

Conclusions:

  • This research aims to define clinically relevant opioid consumption reductions.
  • Improved understanding of intervention effects and enhanced planning for future pain management trials.
  • Contribution to establishing a patient-centered minimal important difference for opioid use in postoperative care.