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. 2016 May 23;2016(5):CD007126. doi: 10.1002/14651858.CD007126.pub3

Maghsoudi 2014.

Methods Randomized, double‐blind, placebo‐controlled multiple dose, 24‐hour study
Medication was administered 30 min after extubation
Participants Type of surgery: percutaneous nephrolithotomy
Paracetamol group
Entered/completing: 50/50
Age (mean, SD): 44.48 +/‐ 12.92
Sex (male, %): 34 (68%)
Placebo group
Entered/completing: 50/50
Age (mean, SD): 42.56 +/‐ 13.57
Sex (male, %): 40 (80%)
Interventions Paracetamol: 100 ml normal saline and 1 g paracetamol IV 30 min after extubation and every 8 h until 24 h (4 g total)
100 ml IV normal saline 30 min after extubation and every 8 h until 24 h
Outcomes Primary: pain intensity (VAS) over first 6 h and 24 h after extubation, demand for opioid analgesia (pethidine 25 to 50 mg IM up to 200 mg per day), total pethidine dose consumed
Secondary: adverse effects
Source of funding Not mentioned
Were treatment groups comparable at baseline? Yes ‐ age, BMI, stone size, operative time, baseline VAS. No mention if # of males balanced – 40 versus 34.
Details of preoperative pain Participants were excluded if they reported use of a NSAID or other analgesic less than 12 h before prescribing the study medications. Also excluded if painful physical conditions that may affect pain assessment after percutaneous nephrolithotomy
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Balanced blocked randomization; randomization schedule was prepared by someone that was blinded to the study.
Allocation concealment (selection bias) Unclear risk Not described
Blinding (performance bias and detection bias) 
 All outcomes Low risk “Serums containing placebo and paracetamol, identical in color and appearance were prepared by an assistant and administered by nursing personnel blinded to the study.” Other group blinded was not specifically stated but assumed to be participants.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Per Results, 2 participants did not complete the study but no additional information was provided. No deviations from the protocol was also noted.
Selective reporting (reporting bias) Low risk Frequency of VAS < or > 4 was not mentioned as an outcome in Methods (Table 2)
Size Unclear risk 50 to 199 participants per arm of the study (50 paracetamol, 50 placebo)