Summary of findings 3. Larger atraumatic needles compared to smaller atraumatic needles for prevention of post‐dural puncture headache (PDPH).
Atraumatic needle (major gauge) compared to atraumatic needle (minor gauge) for prevention of PDPH | ||||||
Patient or population: patients undergoing lumbar punctures with atraumatic needles (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor) Settings: all settings (countries: Canada, France, India, Italy, Spain, UK and USA) Intervention: atraumatic needle ‐ larger gauge (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor) Comparison: atraumatic needle ‐ smaller gauge (Whitacre, Atraucan, Sprotte, Cappe‐Deutsh, Pajunk, Gertie Marx, Durasafe, Cappe, Deutsch and Eldor) | ||||||
Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Assumed risk | Corresponding risk | |||||
Atraumatic needle ‐ smaller gauge | Atraumatic needle ‐ larger gauge | |||||
Onset of PDPH | — | — | RR ranged from 0.38 to 9.3 | 3134 (13 studies) | ⊕⊕⊝⊝ low1,2 | We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other. |
Adverse events: paraesthesia | — | — | RR ranged from 1.03 to 7.61 | 439 (2 studies) | ⊕⊕⊕⊝ moderate1 | We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other. |
Adverse events: backache | — | — | RR ranged from 0.95 to 5.00 | 526 (4 studies) | ⊕⊕⊕⊝ moderate1 | We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other. |
Severe PDPH | — | — | RD ranged from 0 to 0.01 | 1983 (8 studies) | ⊕⊕⊝⊝ low1,2 | We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other. |
Any headache | — | — | RR ranged from 1.13 to 2.17 | 1791 (7 studies) | ⊕⊕⊕⊝ moderate1 | We decided against overall pooling of results because the gauge of a needle could be considered small in one comparison but large in other. |
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; PDPH: post‐dural puncture headache; RD: risk difference; RR: risk ratio | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. |
1Risk of bias downgraded by one level due to unclear reporting (especially related to allocation concealment and random sequence generation issues). 2Imprecision downgraded by one level due unclear clinical decisions indicated by each confidence interval limit.