Okun 1982.
Study characteristics | ||
Methods | Multi‐arm RCT ‐ 5 groups | |
Participants | Hospitalised women within 48hrs of birth and with moderate, severe or very severe uterine or episiotomy pain Department of Clinical Pharmacology, Cedars‐Sinai Medical Center, Los Angeles, USA Women who were breast feeding, and/or had received any analgesic, sedative or psychotropic medication within 6 hrs of the study were excluded |
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Interventions | Interventions: fendosal 100 mg (N = 19), fendosal 200 mg (N = 19), fendosal 400 mg (N = 18) and aspirin 650 mg (N = 20) Control: placebo (N = 18) |
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Outcomes |
Pain intensity was measured on a 5‐point scale of 1 = no pain, 2 = mild pain, 3 = moderate pain, 4 = severe pain and 5 = very severe pain, just before and then hourly from drug administration up to 8 hours, which was the study period. Participants were questioned at 1 and 2 hours whether their pain relief was 50% or greater |
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Notes | Results are extractable for 8 hours after the intervention only Dates of study: NR Funding sources: NR Declarations of interest: NR |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No clear statement |
Allocation concealment (selection bias) | Unclear risk | States only that the capsules were identical looking; unclear if numbered sequentially or coded |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | 1 nurse observer measured the outcomes, but it is not clear if the observer was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing or incomplete data |
Selective reporting (reporting bias) | Low risk | Outcomes prespecified in the study methods are all reported |
Other bias | Low risk | Mean ages, body weights, and pain intensity and type of pain at baseline were comparable across the 5 groups |