Jain 1978a.
Study characteristics | ||
Methods | RCT | |
Participants |
Setting: Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana, USA (assumed from author affiliation) Trial dates: not reported (published in 1978) Inclusion criteria: women with moderate to severe episiotomy pain within 48 hours of a normal vaginal birth Exclusion criteria: nursing; systemic diseases; allergic to aspirin |
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Interventions |
Aspirin (N = 30 randomised) 648 mg aspirin; single oral dose Placebo (N = 30 randomised) Placebo; single oral dose All women: the time between the test drug and previous analgesic, tranquillisers, or sedatives was at least 5 hours |
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Outcomes |
Adequate pain relief as reported by the woman: a trained nurse observer rated pain intensity and relief hourly for 4 hours
The results were not reported in a way to enable us to calculate 'Adequate pain relief as reported by the woman.' Figure 2 in manuscript provides patient self‐rating of pain (continuous, analogue scale) Need for additional pain relief in the first 48 hours for perineal pain: need for extra analgesia during the 4‐hour study period Maternal adverse effects: volunteered or observed side effects |
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Notes |
Funding: not reported Declarations of interests: not reported Additional arms: this 4‐arm trial also assessed piroxicam 20 mg (N = 31) and 40 mg (N = 29); we only included the relevant arms in this review |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "By random assignment"; no other details described |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "double blind"; no further details provided |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Did not report on losses to follow‐up or exclusions |
Selective reporting (reporting bias) | High risk | No access to trial protocol; however results reported incompletely in text |
Other bias | Low risk | Baseline characteristics were reported to be comparable across groups; no other obvious sources of bias identified |