Forskning
Udskriv Udskriv
Switch language
Region Hovedstaden - en del af Københavns Universitetshospital
Udgivet

Assessment of Postoperative Analgesic Drug Efficacy: Method of Data Analysis Is Critical

Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  1. Enhanced Recovery Pathways: Looking Into the Future

    Publikation: Bidrag til tidsskriftLederForskningpeer review

  2. Anesthesia in Enhanced Recovery Pathways for Hip and Knee Arthroplasty: Where Is the Evidence?

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Ketamine as a Rapid Sequence Induction Agent in the Trauma Population: A Systematic Review

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Tsujikawa and Lipid Emulsion

    Publikation: Bidrag til tidsskriftLetterForskningpeer review

  1. Adverse reactions of dimethyl sulfoxide in humans: a systematic review [version 2; peer review: 2 approved with reservations

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  2. A national center for persistent severe pain after groin hernia repair: Five-year prospective data

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  3. Response to Comment on "Polypropylene Mesh and Fertility"

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  4. Groin hernia in children

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

  5. Laparoscopic versus open repair of groin hernias in children: a systematic review and meta-analysis

    Publikation: Bidrag til tidsskriftTidsskriftartikelForskningpeer review

Vis graf over relationer

BACKGROUND: Pain intensity ratings and opioid consumption (OC) are ubiquitous indicators of pain in postoperative trials of the efficacy of interventional procedures. Unfortunately, consensus on the appropriate statistical handling of these outcomes has not been reached. The aim of this article was, therefore, to reexamine original data obtained from a postoperative analgesic drug trial, applying a collection of standard statistical methods in analgesic outcome assessments. Furthermore, a modified integrated assessment method of these outcomes was evaluated.

METHODS: Data from a randomized, double-blind, placebo-controlled study investigating the analgesic efficacy of a regional anesthetic block following a major elective surgical procedure were analyzed. The original data included measurements of pain intensity (visual analog scale [VAS]) at rest and during coughing (VAS0/2/4/6/12/18/24 h) and OC0-6/0-24 h administered by patient-controlled analgesia. The statistical analyses included comparisons of discrete pain intensity scores (VAS0/2/4/6/12/18/24 h), summary measures of pain intensity ratings (area under the curve [AUC]-VAS0-6/0-24 h; mean VAS0-6/0-24 h), and OC0-6/0-24 h. Finally, the analyses also included an integrated assessment of longitudinally measured pain intensity and opioid consumption (PIOC0-6/0-24 h). Also, estimation of effect size, generalized odds ratio of the individual analgesic outcome variables was performed.

RESULTS: Sixty-one patients were included in the final data analysis. Discrete pain intensity ratings differed significantly between the treatment groups at specific postoperative time points, but appropriate correction for multiple comparisons eliminated some of these differences. AUC-VAS0-6 h differed significantly at rest and during coughing, while no difference was found for AUC-VAS0-24 h. In contrast, mean VAS0-6 h and VAS0-24 h differed significantly between treatment groups at rest and during coughing. OC0-6/0-24 h differed significantly between the treatment groups. Finally, also PIOC0-6/0-24 h differed significantly at rest and during coughing.

CONCLUSIONS: Our analyses demonstrate that the applied statistical method may alter the statistical significance and estimates of effect size of analgesic outcome variables in postoperative pain trials. Our findings underline the importance of defining valid statistical methods for future analgesic drug trials. We propose an integrated assessment of longitudinally measured pain intensity and opioid consumption (PIOC). The method combines two interdependent analgesic outcomes, lowers the risk of mass significance, and provides more accurate representation of the dynamic nature of postoperative pain and analgesic drug efficacy.

OriginalsprogEngelsk
TidsskriftAnesthesia and Analgesia
Vol/bind125
Udgave nummer3
Sider (fra-til)1008-1013
Antal sider6
ISSN0003-2999
DOI
StatusUdgivet - sep. 2017

ID: 51710022