7.

Trial sequential analysis of pain (4 to 8 hours) (opioid versus control) 
 The diversity‐adjusted required information size (DARIS) was 445 participants based on a minimal relevant difference (MIRD) of 1 cm on the visual analogue scale, a variance (VAR) of 14.16, an alpha (a) of 5%, a beta (b) of 20%, and a diversity (D²) of 0%. The conventional statistical boundaries (dotted red line) and the trial sequential monitoring boundaries (red line) are crossed by the cumulative Z curve (blue line) after the first trial. Although the DARIS is not reached, the findings are consistent with opioid decreasing pain between 4 and 8 hours compared with inactive control with low risk of random errors.