Tunali 2013.
Methods | Participants randomized to 3 groups to receive interventions at the time of wound closure (supposedly within 30 min from end of surgery) | |
Participants | Type of surgery: microsurgical lumbar discectomy and/or laminectomy Paracetamol group Entered/completing: 20/18 Age (mean, SD): 46.39 ± 10.06 Sex (male, %): 33 Placebo group Entered/completing: 20/20 Age (mean, SD): 48.35 ± 9.93 Sex (male, %): 55 Dexketoprofen group Entered/completing: 20/18 Age (mean, SD): 39.17 ± 11.10 Sex (male, %): 38.9 |
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Interventions | All administered IV in 100 ml infused over 15 min All participants used IV PCA with morphine Paracetamol: 1 g every 6 h for 24 h The study states paracetamol but in discussion says “Paracetamol is an IV formulation of a prodrug of acetaminophen and used as a supplemental analgesic to reduce postoperative pain” Dexketoprofen: 50 mg IV every 8 h for 24 h Placebo: 100 ml normal saline every 8 h for 24 h |
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Outcomes | Primary: pain intensity on 0 to 10 VAS at 0, 1, 2, 6, 12, 24 h post‐op but primary outcome not defined Secondary: sedation on Ramsay score, cumulative PCA morphine consumption at the above time points, adverse effects |
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Source of funding | No funding | |
Were treatment groups comparable at baseline? | No: age in dexketoprofen group lower than in 2 other groups; pain at time 0 in dexketoprofen group substantially lower | |
Details of preoperative pain | Not reported | |
Notes | Frequency of administration different: every 6 h for paracetamol and every 8 h for dexketoprofen and saline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | 1 person prepared sealed envelopes and another person drew an envelope for each case |
Allocation concealment (selection bias) | Unclear risk | Unclear if solutions looked any different |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | The treatment frequency is different (3 times daily versus 4 times daily), true blinding not likely, although study data were collected by a blinded anesthesiologist |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 participants were excluded, with reasons given. Outcomes seem to be reported in full. |
Selective reporting (reporting bias) | Low risk | All outcomes mentioned in Methods reported in Results |
Size | High risk | Fewer than 50 participants per arm of the study (20 paracetamol, 20 placebo, 20 dexketoprofen) |