Summary of findings for the main comparison. Traumatic needles compared to atraumatic needles for prevention of post‐dural puncture headache (PDPH).
| Traumatic needles compared to atraumatic needles for prevention of PDPH | ||||||
| Patient or population: patients undergoing lumbar punctures Settings: all settings (countries: Argentina, Austria, Brazil, Canada, Denmark, Finland, France, Germany, India, Israel, Italy, Korea, Mexico, Nepal, Netherlands, Nigeria, Norway, Pakistan, Spain, Thailand, UK and USA) Intervention: traumatic needles (Quincke, Greene, Hingson Ferguson, Lutz, Brace, Rovenstine, Lemmon) Comparison: atraumatic needles (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 needles | Traumatic needles | |||||
| Onset of PDPH | 30 per 1000 | 64 per 1000 (52 to 80) | RR 2.14 (1.72 to 2.67) | 9378 (36 studies) | ⊕⊕⊕⊝ moderate1 | — |
| Adverse events: paraesthesia | 52 per 1000 | 50 per 1000 (25 to 102) | RR 0.96 (0.47 to 1.96) | 573 (3 studies) | ⊕⊕⊕⊝ moderate1 | — |
| Adverse events: backache | 155 per 1000 | 147 per 1000 (118 to 183) | RR 0.94 (0.78 to 1.13) | 3027 (12 studies) | ⊕⊕⊕⊝ moderate1 | — |
| Severe PDPH | 0 per 1000 | 10 per 1000 | RD 0 (0.00 to 0.01) | 6420 (24 studies) | ⊕⊕⊝⊝ low1,2 | — |
| Any headache | 221 per 1000 | 290 per 1000 (228 to 367) | RR 1.35 (1.17 to 1.57) | 4104 (18 studies) | ⊕⊕⊕⊝ moderate1 | — |
| *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). 2Inconsistency downgraded by one level due to presence of considerable heterogeneity (I2 = 42%), caused by one study focused on diagnostic lumbar punctures (Muller 1994).