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

Rahimi 2010.

Methods Study design: randomized controlled trial (2 arms)
Study duration: not reported
Study setting: hospital, single centre, USA
Participants Adults undergoing elective craniotomy (n = 50)
Inclusion criteria
  1. Adults undergoing above surgery


Exclusion criteria
  1. Pregnant

  2. Age < 18 yrs

  3. Ventilator dependant > 24 hours

  4. Allergy to study medications

  5. Emergency surgery


Mean age, range (years)
  1. 44 (range not reported)


Numbers allocated to each arm
  1. Group intervention (n = 25)

  2. Group control (n = 25)


Male gender
  1. Group intervention: 13/25

  2. Group control: 10/25

Interventions Technique and timing
  1. Oral tramadol 100 mg twice daily plus narcotic medication as required (oxycodone/acetaminophen 5/325 mg every 4 hours as needed and 1 to 2 mg of IV morphine every 2 hours as needed) versus narcotic medication (as above) only


Dosage
As above
Outcomes Primary
  1. Pain as measured by the visual analogue score (VAS)


Secondary
  1. Length of hospital stay

  2. Cost

Notes Funding
None
Other methodologic issues
Lack of details regarding several aspects of study design and methodology including randomization, blinding methods, sample size and timing of outcome measurements
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Reported as randomized but method not reported
Allocation concealment (selection bias) High risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Reported as blinded but authors did not report who was blinded or how they were blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk All participants were followed up and included in the analysis.
Selective reporting (reporting bias) Low risk Outcomes reported as specified
Other bias High risk Lack of details regarding several aspects of study design and methodology including randomization, blinding methods, sample size and timing of outcome measurements