Skovlund 1991a.
Study characteristics | ||
Methods | Randomised controlled trial with a sequential trial design | |
Participants | Location: country Norway but site not clearly identified (maybe Akershus Central hospital, Oslo, Norway) and time of study not stated Included: postpartum women with uterine cramps and possible concomitant episiotomy pain after vaginal birth requesting analgesia Excluded: women allergic to paracetamol |
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Interventions | Postpartum women with uterine pain and possible concomitant episiotomy pain after vaginal birth and who were asking for analgesic and consented to participate were randomly allocated to 1 of 2 groups:
The medications were identical in appearance |
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Outcomes |
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Notes | Dates of study: not stated Funding sources: 1st author supported by a grant from the Norwegian Research Council for Science and the Humanities Declarations of interest: declared as none |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study simply described as randomised, but no further details provided |
Allocation concealment (selection bias) | Unclear risk | No information related to allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double‐blind. "Identical appearing tablets." |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 woman (placebo group) excluded as she had received analgesia 1 hour prior to inclusion. There were 39 women allocated to the paracetamol group and 36 women to the placebo group. Results included for 1 woman in placebo group who was under study when trial stopped. 2 women withdrew after 2 hours observation, no 4‐hour data included. Appropriately‐imputed data were used for women who withdrew before 2 hours |
Selective reporting (reporting bias) | Unclear risk | No published protocol or trial registration available |
Other bias | Low risk | Similar numbers of women in both groups (10 of the 39 women in the paracetamol group and 11 of the 38 women in the control group) had pain medication before enrolling in the study; inclusion criteria stated that women had pain and were requesting analgesia. Graphs presenting results appear to be mislabelled |