Marty 2005.
Methods | Randomized, single dose, double‐blind, active‐controlled parallel‐group Medication administered when baseline pain reached moderate‐to‐severe intensity |
|
Participants | Type of surgery: gynecological Paracetamol group Entered/completing: 80/80 Age (mean, SD): 38.3 ± 12.8 Sex (male, %): 0 Propacetamol group Entered/completing: 81/81 Age (mean, SD): 33.9 ± 12.0 Sex (male, %): 0 |
|
Interventions | Intervention: paracetamol 1g IV in 100 ml solution over 15 min Active control: propacetamol 2 g in 100 ml solution |
|
Outcomes | Primary outcome: tolerability, including pain at infusion site Pain intensity (VRS, VAS) Number of participants requesting rescue medication Patient satisfaction (categorical) |
|
Source of funding | Not mentioned, but senior author was employee of Bristol Myers Squibb | |
Were treatment groups comparable at baseline? | Yes: weight, type of surgery, baseline pain intensity at surgical site. No ‐ age: 38.3 paracetamol versus 33.9 propacetamol. | |
Details of preoperative pain | Patients with any painful physical condition (other than postoperative pain) were excluded. | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomly assigned in a 1:1 ratio according to a computer‐generated list of numbers to either group |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Study drugs mixed by pharmacist or nurse not involved in the study, were administered as a 100 ml solution infused over 15 min |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | "A total of 163 women were enrolled and 161 received the single infusion of study medication. All remaining 161 patients including 2 patients (1 in each group) who did not meet eligibility criteria, were included in the ITT population and analyses of demographic characteristics, tolerability, and efficacy". Not clear if data were imputed. |
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 (80 paracetamol, 81 propacetamol) |