Skip to main content
. 2020 Jul 24;2020(7):CD012129. doi: 10.1002/14651858.CD012129.pub3

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
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
Outcomes Adequate pain relief as reported by the woman: a trained nurse observer rated pain intensity and relief hourly for 4 hours
  • Observer rating of pain intensity on 4‐point scale (0 = none; 1 = slight; 2 = moderate; 3 = severe)

  • Observer rating of pain relief on 5‐point scale (0 = none; 1 = slight 2 = moderate; 3 = marked; 4 = complete)

  • Patient self‐rating of pain from 0 to 1 on a continuous scale (no pain to severe pain)


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
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
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