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

Alam 2012.

Study characteristics
Methods Randomised, double‐blind, placebo‐controlled trial
Study type: single‐centre study
Location: Bangladesh (Chittagong)
Study design: parallel
Randomisation: computer random numbers series
Allocation concealment: not described
Blinding: double‐blind, patients and observer
Follow‐up period: 48 hours
Participants Randomised: 60 (intervention group: 30; control group: 30)
Excluded (post‐randomisation): not described
Gender (women): 32 (53%)
Age (years); mean (standard deviation ‐ SD): intervention group 30.32 (5.83), control group 32.49 (4.69)
Baseline VAS score: mean (SD): intervention group 9.32 (0.83), control group 9.17 (1.69)
Inclusion criteria:
Adult patients (ASA I and II) who developed PDPH after non‐obstetric surgery
Exclusion criteria:
History of cluster headache, convulsion, cerebrovascular accident, pre‐eclampsia, eclampsia, coagulopathy or previous neurological diseases
Interventions Intervention group: 100 mg hydrocortisone, diluted in 2 ml, intravenous 8‐hourly for 48 hours
Control group: 2 ml of normal saline intravenously (placebo) 8‐hourly for 48 hours
Co‐interventions:
  • Conventionally treatment: recumbent positioning, intravenous or oral hydration analgesics with caffeine, stool softeners and soft diet

Outcomes 1. Change in pain severity VAS score after 6, 24 and 48 hours
2. Number of any possible adverse events
3. Number of participants with EBP performed
Notes Post‐dural puncture headache (PDPH): Quote "The mean of headache intensity was measured in all 60 patients after 1 min in upright position." (page 191)
Visual analogue scale (VAS) 10 cm: 0 to 1, no headache; 2 to 4, mild headache; 5 to 7, moderate headache; and 8 to 10, severe headache
Sample size calculation: not described
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The investigator reported the use of a computer random number generator
Allocation concealment (selection bias) Unclear risk No information provided
Blinding (performance bias and detection bias)
All outcomes Unclear risk Quote: "The patients and the single observer were blinded to this study." (Page 191)
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)