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49th Annual Regional Anesthesiology and Acute Pain Medicine Meeting
March 21-23, 2024 | The Hilton Bayfront San Diego | San Diego, California
5491
PATIENT WILLINGNESS TO PARTICIPATE IN RANDOMIZED CLINICAL TRIALS INVOLVING INTRAVENOUS PERIOPERATIVE METHADONE:A SYSTEMATIC REVIEW
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Scientific Abstracts > Acute Pain
Introduction:
•Methadone is a long-acting opioid that has a favorable pharmacokinetic profile for long acting perioperative analgesia.
•Despite recent studies which have demonstrated improved longer acting analgesia and a reduction in the need for postoperative short acting opioids, there is still hesitancy to use methadone perioperatively.
•As a result of its use for the treatment of opioid use disorder (OUD), methadone may have a stigma associated with it in the lay press and among the general population.
•We decided to undertake this systemic review to measure if there is a high rate of patient refusal to participate in perioperative methadone studies.
Material and Methods
•The inclusion criteria for screening were studies in humans that were prospective randomized controlled trials where one study arm was randomized to receive methadone as part of an analgesia pain.
•Exclusion criteria included any study where the full text was not available, and abstracts presented at meetings.
•Primary outcome: the ratio of the number of patients who declined to participate and the number of patients who were approached.
•Secondary outcome: was the ratio of the number of patients who declined to participate and the number of patients who were randomized. Data on the drop out rates, cross over rates, and lost to follow up rates were also collected.
Results
• 23 studies met our inclusion criteria for a full text search. Of the 23 studies that met inclusion criteria, only 9 (39.1%) reported the number of patients that refused to participate and were included in the analysis (Figure 1 & Table 1).
•The 9 trials that reported patient refusal rates, evaluated a total of 1631 patients of which 293 (18.0%) declined to participate.
•Those 9 studies eventually randomized a total of 964 patients making the refusal to randomization rate 30.4%.
•All of the studies that had ratios of refusal to approached greater than 0.20 were based in the United States (Table 1; Figure 2).
Discussion
•Overall, 18% who were approached for methadone studies refused.
•Refusal rates were higher in the United States compared to countries in Europe or South America. (Figure 2)
•Only 9 of the 14 eligible randomized clinical trials reported patient refusal rates. Future trials should be transparent with their patient recruitment strategies.
•Our study highlights that effective patient education will be important for recruitment for future randomized controlled trials.
•Discussing perioperative methadone with patients, as part of an informed consent or as part of general practice, can help change inaccurate and negative perceptions of the medication.