Sen 2014.
| Study characteristics | ||
| Methods | Randomised, treatment‐controlled trial Study type: single‐centre study Location: India (Faridabad) Study design: parallel Randomisation: not described Allocation concealment: not described Blinding: not described Follow‐up period: 24 hours | |
| Participants | Randomised: 40 (intervention group: 20; control group: 20)
Excluded (post‐randomisation): not described
Gender (women): 18 (45%)
Age: text reported that there was no significant difference. Quote "Groups did not differ in age" (Page 115). Table 1 describes age in the intervention and control groups by type of surgery
Baseline VAS score: mean (SD): intervention group 93.5 (5.9), control group 94.6 (4.4)
Inclusion criteria: Patients of ASA I and II suffering from post‐dural puncture headache Exclusion criteria: not described |
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| Interventions | Intervention group: 400 mg theophylline orally Control group: conservative treatment comprising bed rest in a supine position without a head pillow, caffeine‐containing beverages, injectable opioid and/or non‐steroid anti‐inflammatory drug (NSAID) Co‐interventions: not described | |
| Outcomes | 1. Change in pain severity VAS score after 8, 16 and 24 hours 2. Number of participants showing improvements in pain severity 3. Number of any possible adverse events | |
| Notes | Post‐dural puncture headache (PDPH): Quote "Patients under study were asked to mark a 0 to 100 mm VAS in sitting position to facilitate a maximal score at the onset of PDPH." (page 115) Visual analogue scale (VAS) 0 to 100 mm 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 | Unclear risk | No information provided |
| 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 (number of any possible adverse events) that would be expected to have been reported for such a study |
| Size of study | High risk | Total 40 (intervention group: 20; control group: 20) |