Karaman 2010.
| Methods | Randomized, double‐blind, active‐controlled study, multiple dose, 24 h Medication was administered at the end of surgery after skin closure |
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| Participants | Type of surgery: ENT surgery (nasal/sinus, otologic, head/neck) Paracetamol group Entered/completing: 30/30 Age (mean, SD): 48.5 +/‐ 12.1 Sex (male, %): 16 (53%) Dexketoprofen Entered/completing: 30/30 Age (mean, SD): 54.8 +/‐ 8.6 Sex (male, %): 16 (53%) |
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| Interventions | Paracetamol: 1 g IV at the end of surgery then at 6, 12, 18 h (4 g total) Dexketoprofen: 50 mg IV at the end of surgery then repeated twice at an 8‐h interval (150 mg total) Metamizol: 1 g IV at the end of surgery then repeated twice at an 8‐h interval (3 g total, not included in our analysis) |
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| Outcomes | Primary: VAS (0 to 10) and VRS (0 to 3) pain intensity Secondary: adverse events, sedation score, use of rescue medication (pethidine 1 mg/kg for VAS ≥ 30 mm) |
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| Source of funding | Not mentioned | |
| Were treatment groups comparable at baseline? | Yes: demographics; duration of surgery | |
| Details of preoperative pain | Not reported ‐ participants were excluded if they had received analgesics within 12 h before surgery | |
| Notes | — | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Participants and anesthetists were unaware of treatment assignments. All outcome measurements were recorded by the same anesthesia resident who was blinded to assignments. “All medicines were prepared by a nurse who had no other involvement in the study” |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts or protocol violations – complete data set obtained for all groups |
| Selective reporting (reporting bias) | Low risk | All outcomes from Methods section reported in Results section although no data provided for sedation assessment |
| Size | High risk | Fewer than 50 participants per arm of the study (30 paracetamol, 30 dexketoprofen) |