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. 2019 Nov 21;2019(11):CD011931. doi: 10.1002/14651858.CD011931.pub2

Shimony 2016.

Methods Study design: randomized controlled trial (2 arms)
Study duration: not reported
Study setting: hospital, single centre, Israel
Participants Adults undergoing elective craniotomy for tumour resection (n = 100)
Inclusion criteria
  1. ASA I to III adults undergoing above surgery


Exclusion criteria
  1. Allergy to propofol, pregabalin, opioids, NSAIDS, dipyrone

  2. Chronic pain

  3. Psychiatric disorder

  4. Chronic usage of sedatives, antidepressants, antipsychotics or antiepileptic drugs

  5. Receiving anti‐emetic or anticonvulsant drugs

  6. Age < 18 or > 80

  7. In military service

  8. Emergency surgery

  9. Pregnant

  10. Planning to undergo deep brain stimulation

  11. Inability to consent

  12. Severe liver or renal failure

  13. Those expected to require a prolonged hospital stay after surgery


Mean age, range (years)
  1. 39 (18 to 60)


Numbers allocated to each arm
  1. Group intervention (n = 50)

  2. Group control (n = 50)


Male gender
  1. Group intervention: 42% (denominator not clear)

  2. Group control: 55% (denominator not clear)

Interventions Technique and timing
  1. Pregablin, given orally, the evening before surgery, 90 minutes before surgery, 2 hours after surgery and every 12 hours thereafter for a total of 72 hours versus starch placebo given at the same time points


Dosage
150 mg per dose
Outcomes Primary
  1. Pain score day 0 to 3 after surgery as rated by numerical rating scale (NRS) (measured at days 0, 1, 2 and 3)


Secondary
  1. Analgesic consumption day 0 to 3 after surgery

  2. Late pain scores (up to 3 months)

  3. Use of analgesics after hospital discharge

  4. Length of stay

  5. Patient satisfaction

  6. Anxiety levels

  7. Sleep quality

  8. Anti‐emetic usage

Notes Funding
None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomization list
Allocation concealment (selection bias) High risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk It was clear how participants were blinded. Quote: ''patients in the placebo group were given identical capsules containing 500 mg of starch at the same time points''.
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk The trial was reported as 'double‐blinded' but it was not clear how investigations were blinded.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 12 participants were lost to follow‐up, 5 in the intervention group and 7 in the control group. The reasons were not clearly explained in the report with the CONSORT flowchart mentioning these as having (quote): ''dropped out''. However, the authors did perform an intention‐to‐treat analysis.
Selective reporting (reporting bias) Low risk Outcomes reported as specified
Other bias Unclear risk Massive number of comparisons were made with no statistical adjustment for multiple testing.