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

Kokki 1996.

Methods

  • Design: parallel‐group (2 arms)

  • Country: Finland

  • Multisite: no

  • Needle tip used: diamond

  • Needle diameter used: 25 vs 29

  • Number of attempts: 1.2 vs 1.4

  • Procedure: anaesthesia

  • Site of the puncture: L3‐4 or L4‐5

  • Training level of those who administered the puncture: unknown

  • Median or paramedian technique: midline approach

  • Type of anaesthetic: isobaric or hyperbaric bupivacaine 0.5% at a dose of 0.3 mg/kg‐I was used for children under 7 years old. Older children were given hyperbaric lignocaine 5% at a dose of 1 mg/kg‐l.

  • Patient position: lateral position
Participants 1. 60 ASA physical status 1 and 2 children aged one to 13 years, scheduled for day case operations of the lower abdomen, genital area or lower extremities, were enrolled
Patients were randomized to:

  • 25 G Quincke group: 30 (50%)

  • 29 G Quincke group: 30 (50%)


2. No patients were excluded at follow‐up
3. Main characteristics of patients:

  • Age, months (mean, SD): 25 G Quincke group: 86, 48; 29 G Quincke group: 80, 34

  • Height (mean, SD): 25 G Quincke group: 121, 27; 29 G Quincke group: 120, 17

  • Weight (mean, SD): 25 G Quincke group: 27, 14; 29 G Quincke group: 24, 11

  • Gender ‐ male (number): 25 G Quincke group: 21; 29 G Quincke group: 23
Interventions

  1. 25 G Quincke 89 mm long needle (Vygon, France). Needle bevel was parallel to the longitudinal dural fibres.

  2. 29 G Quincke 89 mm long needle (Vygon, France). Needle bevel was parallel to the longitudinal dural fibres.


Co‐intervention: at the end of the operation the children were given ibuprofen 10 mg/kg‐1 as a suppository for pre‐emptive pain therapy
Outcomes Outcomes were not classified as primary or secondary

  1. Spinal puncture time

  2. Time for CSF to appear at the needle hub

  3. Injection time of the local anaesthetic

  4. Postoperative complaints

  5. PDPH

  6. Non‐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: " The children were randomly allocated (…)" (page 116)
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