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. 2017 Apr 7;2017(4):CD010807. doi: 10.1002/14651858.CD010807.pub2

Pedersen 1996.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Norway

  • Multisite: no

  • Needle tip used: 22 G Quincke vs 22 G Whitacre

  • Needle diameter used: 22 G

  • Number of attempts: unknown

  • Procedure: myelography

  • Site of the puncture: L2‐3

  • Training level of those who administered the puncture: unknown

  • Median or paramedian technique: unknown

  • Amount of CSF extracted: unknown

  • Amount of injected volume: Iohexol 15 ml

  • Patient position: unknown
Participants 1. 107 consecutive patients (inpatient and outpatient) referred to the Department of Radiology for lumbar myelography were enrolled
Number of patients randomized per arm: unclear
2. 7 patients (6.5%) were excluded from analysis because they were operated within the first 7 days or they did not returned the questionnaire
146 patients were analysed:

  • 22 G Quincke group: 53 patients

  • 22 G Whitacre group: 47 patients


3. Main characteristics of patients: 58 men, 42 women, age range: 20 to 82 years, mean: 50.5 years)
Interventions

  1. 22 G (0.7 mm) Quincke needle (Spinocan, B Braun Melsungen, Germany)

  2. 22 G Whitacre (Becton‐ Dickinson). Puncture was done first with a 19 G needle through the skin and subcutis
Outcomes Outcomes were not classified as primary or secondary

  1. Headache/PDPH

  2. Low back pain

  3. Nausea, dizziness

  4. Severity of PDPH
Notes

  1. Trial registration: not stated

  2. Funder: not stated

  3. Role of funder: not stated

  4. A priori sample size estimation: no

  5. Conducted: not stated

  6. Declared conflicts of interest: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias. Quote: "were randomized into two groups (..)" (page 184)
Allocation concealment (selection bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of participants (performance bias) Unclear risk Insufficient information to score this item as low or high risk of bias
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to score this item as low or high risk of bias
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 6.5% of patients were lost to follow‐up
Selective reporting (reporting bias) Low risk All patient‐important outcomes were reported
Other bias Low risk No other biases were identified