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

Fox 1996.

Methods

  • Design: factorial 2 x 2 (needle x temperature of the contrast agent)

  • Country: Germany

  • Multisite: no

  • Needle tip used: pencil vs diamond

  • Needle diameter used: 21 G vs 22 G

  • Number of attempts: unknown

  • Procedure: myelography

  • Site of the puncture: unknown

  • Training level of those who administered the puncture: experienced neuroradiologists

  • Patient position: sitting
Participants 1. 412 patients undergoing thoracic/cervical or lumbar myelographies were enrolled
Exclusion criteria: unclear
Patients randomized to:

  • 21 G Sprotte group: 206 patients (50%)

  • 22 G Quincke group: 206 patients (50%)


Also patients inside each group were randomized to:

  • 37 °C warm cold contrast agent

  • 21 °C warm cold contrast agent


2. No patients were excluded from analysis
3. Main characteristics of patients:

  • Age (mean, SD): 21 G Sprotte group: 53.4, 7.3; 22 G Quincke group: 54.8, 7.4

  • Gender ‐ male (number): 21 G Sprotte group: 104; 22 G Quincke group: 107

  • Lumbar myelography (number): 21 G Sprotte group: 110; 22 G Quincke group: 120

  • Number of unsuccessful punctures: 21 G Sprotte group: 10; 22 G Quincke group: 9
Interventions

  1. 21 G Sprotte group: Fa.Pajunkâ, Außendurchmesser: 0.8 mm

  2. 22 G Quincke group: Fa. Becton‐Dickinson, Außendurchmesser: 0.7 mm

  3. Co‐intervention: after myelography, all patients were prescribed bed rest for at least 2 hours without special storage recommendation and were recommended additional fluid intake of 2 to ‐3 L
Outcomes Outcomes were not classified as primary or secondary

  1. Headaches, their duration, intensity and character

  2. Nausea, vomiting, tinnitus, dizziness and neck stiffness
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: August 1995 to July 1996

  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: "In a prospective randomized trial the incidence of complaints after lumbar puncture…" (page 922)
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 No 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