Methods | RCT | |
Participants |
Setting: Sinai Hospital of Baltimore, MD, USA (assumed from affiliation) Inclusion criteria: women with no systemic medical illness, experiencing moderate to severe episiotomy pain within 48 hours following an otherwise uncomplicated vaginal birth Exclusion criteria: "those used by Hermann et al" |
|
Interventions |
Aspirin (N randomised was unclear; N = 40 analysed) 650 mg aspirin; single dose in identical capsules Placebo (N randomised was unclear; N = 40 analysed) Placebo; single dose in identical capsules |
|
Outcomes |
Adequate pain relief as reported by the woman: one investigator assessed pain intensity and relief hourly for 6 hours;
Need for additional pain relief in the first 48 hours for perineal pain: frequency of re‐medication Maternal adverse effects: women were observed hourly for adverse reactions |
|
Notes |
Funding: "We would like to acknowledge the support of Sandoz, Inc. in this study" Declarations of interests: not reported Additional arms: this was a 4‐arm trial also assessed fluproquazone 100 mg (N = 41 analysed) and 200 mg (N = 39 analysed); we included only the relevant arms in this review |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned" |
Allocation concealment (selection bias) | Unclear risk | No detail provided |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quotes: "double‐blind"… "All medication was supplied in identical capsules… packaged in individually sealed envelopes" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Considered reasonable to assume blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | In the whole trial, there were 166 who entered, and 160 provided "valid data for analyses"; other losses/exclusions not clearly reported |
Selective reporting (reporting bias) | Unclear risk | No access to trial protocol to further assess; scales used to assess pain intensity and relief (needed to use SPID and TOTPAR scores to calculate adequate pain relief) were not reported |
Other bias | Unclear risk | Baseline characteristics not reported |