Unal 2013.
Methods | Administration of IV paracetamol versus IV dexketoprofen versus placebo during incision closure | |
Participants | Type of surgery: total abdominal hysterectomy Paracetamol group Entered/completing: 21/20 Age (mean, SD): 48.1 ± 3.6 Sex (male, %): 0 Dexketoprofen group Entered/completing: 22/20 Age (mean, SD): 47.7 ± 5.9 Sex (male, %): 0 Placebo group Entered/completing: 21/20 Age (mean, SD): 48.1 ± 4.5 Sex (male, %): 0 |
|
Interventions | Paracetamol 1 g/100 ml in 15 min IV infusion, then every 6 h for 24 h Dexketoprofen: 50 mg in 100 ml 15 min IV infusion, then every 8 h for 24 h Placebo: normal saline 100 ml 15 min IV infusion, then every 6 h for 24 h |
|
Outcomes | Primary: differences in cumulative 24 h morphine consumption Secondary: VAS pain scores, adverse events, patient satisfaction |
|
Source of funding | None | |
Were treatment groups comparable at baseline? | Yes: weight, height, BMI, ASA 1/2, anesthesia duration, surgery duration | |
Details of preoperative pain | Participants with preoperative pain or regular analgesic use excluded | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated block random allocation |
Allocation concealment (selection bias) | Low risk | Sealed, opaque envelopes |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Unblinded person preparing drugs, blinded person assessed outcomes. Unclear if the solutions looked the same. Drug administration frequency different among groups (3 versus four times daily), so blinding might have been compromised |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Number of dropouts low, evenly distributed among groups and reasons for dropout do not appear to be related to treatment |
Selective reporting (reporting bias) | Unclear risk | Incomplete description of methodology for patient satisfaction assessment and incomplete presentation of data |
Size | High risk | Fewer than 50 participants per arm of the study (21 paracetamol, 22 dexketoprofen, 21 placebo) |