Shimia 2014.
Methods | Double‐blind, randomized, placebo‐controlled. Single dose of intravenous paracetamol within the last 20 min of surgery or placebo. | |
Participants | Type of surgery: lumbar discectomy Paracetamol group Entered/completing: dropouts not reported; presumably 24/24 Age (mean, SD): 46.50 ± 14.07 Sex (male, %): 46.2% for both groups Placebo group Entered/completing: dropouts not reported; presumably 28/28 Age (mean, SD): 52.25 ± 11.46 Sex (male, %): 46.2% for both groups |
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Interventions | Paracetamol: 1 g in 100 ml normal saline. Duration of administration not stated. 100 ml normal saline. Duration of administration not stated. |
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Outcomes | Primary: pain on 0 to 10 VAS at 1, 6, 12, 18, 24 h after surgery Morphine dosage for the first 24 h postop Secondary: Adverse effects |
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Source of funding | Tabriz University of Medical Sciences | |
Were treatment groups comparable at baseline? | Yes: age, sex | |
Details of preoperative pain | Patients with preoperative treatment with narcotics, benzodiazepines, or clonidine were excluded | |
Notes | — | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomization method not described |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | All local anesthetic solutions and adjuvant drugs were prepared by an anesthesiologist who was not involved in the performance of the study agents, patient care, or data collection. No mention that interventions appeared identical. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Unclear if all participants completed the study |
Selective reporting (reporting bias) | Unclear risk | Adverse effects assessment mentioned in methods, but article states there were no side effects related to treatment (without any detail) |
Size | High risk | Fewer than 50 participants per arm of the study (24 paracetamol, 28 placebo) |