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. 2015 Jul 15;2015(7):CD007887. doi: 10.1002/14651858.CD007887.pub3

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
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:
  • 18 to 40 years

  • ASA I and II

  • Headache after spinal anaesthesia for caesarean section


Exclusion criteria:
Cluster headache, convulsion, cerebrovascular accident, pre‐eclampsia, eclampsia, high intracranial pressure, coagulopathy or previous neurologic disease
Interventions Intervention group: 200 mg hydrocortisone intravenously as a bolus and 100 mg hydrocortisone every 8 hours for 48 hours
Co‐interventions:
  • All patients were treated conventionally: complete bed rest, hydration (serum dextrose saline 3 L/4 hours) and analgesics (acetaminophen 2 325 mg tablets every 6 hours and intravenous pethidine 50 mg every 12 hours)

Outcomes
  1. Number of participants with EBP performed

  2. Change in pain severity VAS score after 6, 24 and 48 hours

  3. Number of any possible adverse events

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
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)