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 |
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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:
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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) |