TY - JOUR
T1 - Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments
T2 - Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations
AU - Gewandter, Jennifer S.
AU - Smith, Shannon M.
AU - Dworkin, Robert H.
AU - Turk, Dennis C.
AU - Gan, Tong J.
AU - Gilron, Ian
AU - Hertz, Sharon
AU - Katz, Nathaniel P.
AU - Markman, John D.
AU - Raja, Srinivasa N.
AU - Rowbotham, Michael C.
AU - Stacey, Brett R.
AU - Strain, Eric C.
AU - Ward, Denham S.
AU - Farrar, John T.
AU - Kroenke, Kurt
AU - Rathmell, James P.
AU - Rauck, Richard
AU - Brown, Colville
AU - Cowan, Penney
AU - Edwards, Robert R.
AU - Eisenach, James C.
AU - Ferguson, McKenzie
AU - Freeman, Roy
AU - Gray, Roy
AU - Giblin, Kathryn
AU - Grol-Prokopczyk, Hanna
AU - Haythornthwaite, Jennifer
AU - Jamison, Robert N.
AU - Martel, Marc
AU - Mcnicol, Ewan
AU - Oshinsky, Michael L.
AU - Sandbrink, Friedhelm
AU - Scholz, Joachim
AU - Scranton, Richard
AU - Simon, Lee S.
AU - Steiner, Deborah
AU - Verburg, Kenneth
AU - Wasan, Ajay D.
AU - Wentworth, Kerry
N1 - Publisher Copyright:
Copyright © 2021 The Author(s).
PY - 2021/11/1
Y1 - 2021/11/1
N2 - Randomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.
AB - Randomized clinical trials have demonstrated the efficacy of opioid analgesics for the treatment of acute and chronic pain conditions, and for some patients, these medications may be the only effective treatment available. Unfortunately, opioid analgesics are also associated with major risks (eg, opioid use disorder) and adverse outcomes (eg, respiratory depression and falls). The risks and adverse outcomes associated with opioid analgesics have prompted efforts to reduce their use in the treatment of both acute and chronic pain. This article presents Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) consensus recommendations for the design of opioid-sparing clinical trials. The recommendations presented in this article are based on the following definition of an opioid-sparing intervention: any intervention that (1) prevents the initiation of treatment with opioid analgesics, (2) decreases the duration of such treatment, (3) reduces the total dosages of opioids that are prescribed for or used by patients, or (4) reduces opioid-related adverse outcomes (without increasing opioid dosages), all without causing an unacceptable increase in pain. These recommendations are based on the results of a background review, presentations and discussions at an IMMPACT consensus meeting, and iterative drafts of this article modified to accommodate input from the co-authors. We discuss opioid sparing definitions, study objectives, outcome measures, the assessment of opioid-related adverse events, incorporation of adequate pain control in trial design, interpretation of research findings, and future research priorities to inform opioid-sparing trial methods. The considerations and recommendations presented in this article are meant to help guide the design, conduct, analysis, and interpretation of future trials.
KW - Clinical trial methods
KW - IMMPACT recommendations
KW - Opioid sparing
UR - https://www.scopus.com/pages/publications/85119089818
U2 - 10.1097/j.pain.0000000000002283
DO - 10.1097/j.pain.0000000000002283
M3 - Review article
C2 - 33863862
AN - SCOPUS:85119089818
SN - 0304-3959
VL - 162
SP - 2669
EP - 2681
JO - Pain
JF - Pain
IS - 11
ER -