Noyan 2007.
Study characteristics | ||
Methods | Randomised, double‐blind, controlled trial Study type: single‐centre study Location: Iran (Tehran) Study design: parallel Randomisation: not described Allocation concealment: not described Blinding: blinding of participants and key study personnel Follow‐up period: 48 hours |
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Participants | Randomised: 60 (intervention group: 30; control group: 30) Excluded (post‐randomisation): not described Gender (women): 60 (100%) Age (years); mean (SD): 27.1 (3.45) Baseline VAS score: mean (SD): intervention group 9.20 (0.71); control group 9.07 (0.69) Inclusion criteria:
Exclusion criteria: Cluster headache, convulsion, cerebrovascular accident, pre‐eclampsia, eclampsia, high intracranial pressure, coagulopathy or previous neurologic disease |
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Interventions |
Intervention group: 200 mg hydrocortisone intravenously as a bolus and 100 mg hydrocortisone every 8 hours for 48 hours Co‐interventions:
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Outcomes |
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Notes | Post‐dural puncture headache (PDPH): Quote "Headache after spinal anaesthesia". (Page 416) Visual analogue scale (VAS): 0 to 1 no headache; 2 to 4 mild headache, 5 to 7 moderate headache; 8 to 10 severe headache Sample size calculation: not described |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided. Described as randomised |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "Parturient women and observer did not know which patient had received hydrocortisone". (Page 418) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
Selective reporting (reporting bias) | High risk | The study report fails to include results for a key outcome (PDPH persistence of any severity at follow‐up) that would be expected to have been reported for such a study |
Size of study | High risk | Total 60 (intervention group: 30; control group: 30) |