Jahr 2012 Study 2, 65‐.
| Methods | Randomized, double‐blind, placebo‐controlled, single dose study evaluated 6 h postop Study entry occurred the day after surgery. |
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| Participants | Type of surgery: orthopedic (THA) Paracetamol group Entered/completing: 19/19 Age (mean, SD): 52.6 (7.9) Sex (male, %): 9 (47.4%) Placebo Entered/completing: 17/17 Age (mean, SD): < 65: 57.2 (6.4) Sex (male, %): 8 (47.1%) |
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| Interventions | Paracetamol: 1000 mg IV as a single dose Placebo Each arm had free access to PCA (details not specified including if it could be different opioids in PCA) |
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| Outcomes | Primary: pain relief, pain intensity, total rescue medication, median time to rescue, SPID6 Secondary: adverse events |
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| Source of funding | Not mentioned | |
| Were treatment groups comparable at baseline? | Yes: age, sex, weight, height, ASA classification, baseline PI | |
| Details of preoperative pain | Not reported | |
| Notes | Study terminated early due to an issue unrelated to efficacy or safety of the interventions. Precipitates were found in the placebo vials. Participants were required to have moderate pain the day after surgery. Baseline PI scores were not statistically different between groups (VAS 0 to 10). Details regarding drugs used/dosing of opioid PCA for all participants are lacking. (“…each arm having free access to PCA opioids.”) | |
| 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 | Unclear risk | Not described; reported as double‐blind |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | ITT analysis: WOCF if a participant was given rescue medication within the first 4 h after dosing LOCF if a participant missed the 4‐hour mean PI assessment and had not received rescue medication or if a participant terminated the study due to an adverse event Extrapolation if a participant missed one mean PI assessment and no rescue medication was received |
| Selective reporting (reporting bias) | Unclear risk | Reported all outcomes but no data presented for pain relief |
| Size | High risk | Fewer than 50 participants per arm of the study (19 paracetamol, 17 placebo) |