Juhl 2006.
Methods | Randomized, double‐blind, double‐dummy, active‐ and placebo‐controlled Medication administered when baseline pain reached moderate‐to‐severe intensity within 6 h of surgery |
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Participants | Type of surgery: third molar extraction Paracetamol group Entered/completing: 132/132 Age (mean, SD): 25.0 ± 2.6 Sex (male, %): 41 Placebo group Entered/completing: 33/33 Age (mean, SD): 25.2 ± 2.8 Sex (male, %): 55 |
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Interventions | Intervention: IV paracetamol 1 g Control: IV paracetamol 2 g (not included in our analysis) Placebo: 100 ml solution All interventions administered in 100 ml solution for each 1 g of paracetamol (or placebo) over 15 min |
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Outcomes | Pain relief (VAS and VRS) and derived TOTPAR Pain intensity (VAS and VRS) Time to request of rescue medication Global evaluation (categorical) |
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Source of funding | Supported by Bristol‐Myers Squibb Company | |
Were treatment groups comparable at baseline? | Yes: demographics; ASA classification; number of teeth removed; baseline postoperative pain intensity; surgical trauma No: longer duration of surgery in the IV paracetamol 1 g group in comparison with the IV paracetamol 2 g and placebo groups |
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Details of preoperative pain | Participants with other painful physical conditions that might confound pain assessment were excluded | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Block randomization 4:4:1, each block n = 9 |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | A double‐dummy method was used to assure double‐blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | ITT analysis using LOCF. Unclear how many participants had data imputed. |
Selective reporting (reporting bias) | Low risk | All outcomes from Methods section reported in Results section, but SPID was only calculated using categorical pain intensity despite being measured with both categorical and VAS scales |
Size | Unclear risk | 50 to 199 participants per arm of the study (132 paracetamol, 33 placebo) |