Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT04779567
Description:
For numerical variables, baseline characteristic data were analyzed and represented with mean±SD, or median with interquartile range (IQR), according to data type and distribution. Categorical variables are presented as frequency and percentage.
For bivariate analysis, Student T-test or ANOVA were used for enough sample size to assume Normal distribution of the averages by Central Limit Theorem, and Wilcoxon's rank sum test for non-normal distribution data.
Finally, multivariate mixed models will be adjusted for interest scores: VAS, VNRS and MEEDs at 48 hours. As fixed effects in the model, we will consider de intervention (placebo or paracetamol) and other factors (as tabacco) and the patient as the random effect. A significance of 0.05 will be considered. The analyzes will be performed using the statistical package STATA 14.0.
Study:
NCT04779567
Study Brief:
Usefulness of Acetaminophen Associated With Strong Opioids for Acute Pain in Cancer Patients