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

Zhou 2001.

Methods Randomized, double‐blinded, double‐dummy, placebo‐ and active‐controlled
Medication administered on postoperative day 1 when baseline pain reached moderate‐to‐severe intensity
Participants Type of surgery: orthopedic
Propacetamol group
Entered/completing: 60/57
Age (mean, SD): 61.4 ± 12.0
Sex (male, %): 37
Ketorolac group
Entered/completing: 28/27
Age (mean, SD): 60.6 ± 11.1
Sex (male, %): 22
Placebo group
Entered/completing: 55/52
Age (mean, SD): 60.9 ± 12.4
Sex (male, %): 40
Interventions Intervention: 2 g propacetamol over 15 min
Control: 15 mg ketorolac (not included in our analysis)
Control: 30 mg ketorolac
Placebo: saline
Outcomes Time to onset of and number of patients experiencing analgesia (double‐stopwatch method)
Pain intensity at rest and with activity (VRS, VAS) and derived summary measures
Pain relief (categorical) and derived summary measures
Time to, number of patients requesting, and consumption of rescue medication (morphine via PCA)
Global evaluation (categorical)
Source of funding Supported in part by a grant from UPSA Inc., France, and in part by the White Mountain Institute (a non–for profit public charity) in Los Altos, CA
Were treatment groups comparable at baseline? Yes: demographic, anesthetic and surgical characteristics
Details of preoperative pain Not reported
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated schedule
Allocation concealment (selection bias) Unclear risk Not described
Blinding (performance bias and detection bias) 
 All outcomes Low risk All study medication solutions prepared by a hospital pharmacist who was not involved in the data collection. Double‐dummy technique employed.
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Although 172 patients were initially randomized into the study groups, 164 received the study medication and were included in the intention‐to‐treat analysis
Selective reporting (reporting bias) Low risk Free of selective reporting. All outcomes from Methods section reported in Results section.
Size Unclear risk 50 to 199 participants per arm of the study (60 propacetamol, 28 ketorolac, 55 placebo)

AE = adverse event; ASA = American Society of Anesthesiologists physical status classification system; AUC = area under the curve; BMI: body mass index; BOCF = baseline observation carried forward; BP = blood pressure; DSST = digit symbol substitution test; h = hour; HR = heart rate; ICU = intensive care unit; IM = intramuscular; INR = international normalized ratio; IQR = interquartile range; ITT = intention‐to‐treat; IV = intravenous; LA = local anesthetic; LOCF = last observation carried forward; min = minutes; NRS = numerical rating scale; NS = normal saline; N/V = nausea/vomiting; OR = operating room; PACU = post anesthesia care unit; PCA = patient‐controlled analgesia; PI = pain intensity; PT = prothrombin time; SD = standard deviation; SPID = summed pain intensity difference; TDT = Trieger dot test; THA = total hip arthroplasty; TOTPAR = total pain relief; VAS = visual analog scale; VPS = verbal pain score; VRS = verbal rating scale; WOCF = worst observation carried forward.