The Use of Intraoperative Methadone in Children Undergoing Open Urological Surgery: a Randomized, Double-blind Trial
Phase: PHASE3
Conditions: Pain, Acute, Pain, Postoperative, Children, Only
Sponsor: University of Aarhus

22.02.2024 
 
Sta$s$cal analysis plan for METACEBO,  
NCT04680286 
 
The following plan was decided upon before obtaining A and B list from the Hospital Pharmacy.  
 
Missing data are assumed to be missing at random.  
 
Primary outcomes are opioids (yes/no) within 3 hours following extubaIon (or unIl discharge), and highest FLACC-
score within 3 hours following extubaIon (or unIl discharge).  
 
Primary outcomes will be analyzed paired or unpaired t-test for diﬀerence, depending on distribuIon. For the 
dichotomous outcome (opiods: yes/no) a X2 test will be performed. FLACC scores will be presented visually in a plot 
with FLACC over Ime.  
 
Secondary outcomes will be reported with medians (interquarIle range) and compared at various Ime-points 
between the group using the Mann-Whitney U test.  
 
Outcomes regarding opioid consumpIon at home and adverse events will be dichotomized and presented with X2 test.