Koppert 2006.
Methods | Randomized, double‐blind, controlled, multiple dose study; evaluated outcomes over at least 3 days. Medication was administered immediately after surgery upon arrival in the PACU. | |
Participants | Type of surgery: hip replacement or surgery of the femoral shaft Paracetamol group Entered/completing: 27/25 Age (mean, SD): 76.7 +/‐ 8.9 Sex (male, %): 15 (55.6%) Parecoxib group Entered/completing: 28/25 Age (mean, SD): 76 +/‐ 8 Sex (male, %): 11 (39.3%) Placebo group (saline) Entered/completing: 28/25 Age (mean, SD): 76.7 +/‐ 8.6 Sex (male, %): 12 (42.9%) |
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Interventions | Paracetamol: IV infusion of 1000 mg paracetamol (Perfalgan) over 10 min; admin at 6‐h intervals for at least 3 days Parecoxib: 40 mg IV over 10 min (Dynastat); admin at 12‐h intervals for at least 3 days Placebo: saline IV over 10 min |
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Outcomes | Primary: renal function: blood samples (serum Cystatin C, creatinine, blood urea nitrogen, liver biochemistry); urine samples (creatinine clearance, urinary excretion of sodium, potassium, albumin, alpha1‐microglobulin; fluid balance (CVP) Secondary: pain intensity (NRS 0 to 10), rescue medication usage including morphine equianalgesic dosages |
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Source of funding | Supported by Bristol‐Meyers Squibb | |
Were treatment groups comparable at baseline? | “All groups were comparable with regard to age, weight, height, distribution of sex, preexisting diseases, and ASA status…. Type and lengths of surgical and anesthetic procedures across the treatment groups were similar… Furthermore, consumption of crystalloids and colloids were similar.” | |
Details of preoperative pain | Not reported | |
Notes | “If a patient had received NSAIDs or COX‐2 inhibitors, there was a washout period of at least 72 h and the weak opioid, tramadol, was provided as a substitute.” | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Randomization of the study medication (parecoxib versus paracetamol versus saline) was performed by computer‐generated codes maintained in sequentially numbered, opaque envelopes. Additional envelopes were provided if participants had to be excluded after recruitment and randomization.” |
Allocation concealment (selection bias) | High risk | Despite use of sequentially numbered envelopes, participants and nursing staff on ward were unblinded |
Blinding (performance bias and detection bias) All outcomes | High risk | Anesthesiologist, nursing staff, and investigators were blinded. All study medication solutions were prepared by a hospital pharmacist who was not involved in the data collection. On the ward, participants and nursing staff were unblinded. How blinding was maintained was not described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data. All participants that did not complete the study were accounted for. |
Selective reporting (reporting bias) | Low risk | All outcomes were reported in Results |
Size | High risk | Fewer than 50 participants per arm of the study (27 paracetamol, 28 parecoxib, 28 placebo) |