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. 2017 Feb 9;2017(2):CD012129. doi: 10.1002/14651858.CD012129.pub2
Methods RCT
Participants Setting: Cedars‐Sinai Medical Center, Los Angeles, California, USA (assumed from affiliation).
Inclusion criteria: hospitalised women with moderate, severe or very severe pain due to uterine cramps or episiotomy within 48 hours of delivery (94 women in total with episiotomy pain)
Exclusion criteria: breastfeeding; receipt of any analgesic, sedative or psychotropic medication within 6 hours before administration of the study drug
Interventions Aspirin (N = 20 randomised)
650 mg aspirin; single oral dose of 2 x 325 mg identical looking capsules
Placebo (N = 18 randomised)
Placebo; single oral dose of 2 identical looking capsules
Outcomes Adequate pain relief as reported by the woman: 1 nurse observer recorded pain intensity hourly for 8 hours; intensity was rated from 1 to 5 (1 = no pain; 2 = mild pain; 3 = moderate pain; 4 = severe pain; 5 = very severe pain); pain intensity differences were calculated, as were SPID scores at 4, 6, and 8 hours; the time of maximum pain relief; duration of pain relief; the proportion of women with at least 50% pain relief 1 and 2 hours after treatment
Need for additional pain relief in the first 48 hours for perineal pain: proportion requiring additional analgesics
Adverse effects: adverse effects mentioned by women were recorded
No data included in the meta‐analyses as results were not reported separately for women with post‐episiotomy pain
Notes Funding: not reported
Declarations of interests: not reported
Additional arms: this was a 5‐arm trial also assessed fendosal 100 (N = 19), 200 (N = 19) and 400 mg (N = 18); we included only the relevant arms in this review
Note: trial also included women with postpartum uterine cramps pain; not included in review (157/250); no data were able to be included in the meta‐analyses as results were not reported separately for women with post‐episiotomy pain
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Assignment to treatment was randomised"
Allocation concealment (selection bias) Unclear risk No detail provided
Blinding of participants and personnel (performance bias) All outcomes Low risk Quotes: "double‐blind" and "identical looking capsules"
Blinding of outcome assessment (detection bias) All outcomes Low risk As above; 1 nurse observer recorded the pain intensity scores prior and hourly after administration of medication, reasonable to assume that outcome assessment is blinded
Incomplete outcome data (attrition bias) All outcomes High risk A total of 250 eligible women were "admitted to the study"… "The PI scores from patients taking another analgesic were handled as treatment failures by substituting the initial PI score for all hours after the analgesic was taken"
Selective reporting (reporting bias) Unclear risk Results (such as SPID scores) were reported incompletely in text
Other bias Low risk Baseline characteristics (such as initial intensity and type of pain; age and weight) were comparable between groups