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

Dilmen 2016.

Methods Study design: randomized controlled trial (4 arms)
Study duration: June 2013 to January 2015
Study setting: hospital, single centre, Turkey
Participants Adults undergoing elective supratentorial craniotomy (n = 83)
Inclusion criteria
  1. ASA I to III participants


Exclusion criteria
  1. Neurological disorders compromising communication

  2. Aphasia

  3. Drug or alcohol addiction

  4. Chronic pain

  5. Raised intracranial pressure

  6. Allergy to any study drug

  7. Liver or kidney dysfunction

  8. Dementia

  9. Peptic ulcer disease

  10. Glasgow coma score < 15


Mean age, range (years)
  1. 44 (18 to 70)


Numbers allocated to each arm
  1. Group 1: dexketoprofen: 18

  2. Group 2: paracetamol :20

  3. Group 3: metamizole: 19

  4. Group 4: saline control: 18


Male gender
  1. Group 1: 9/18

  2. Group 2: 11/20

  3. Group 3: 8/19

  4. Group 4: 11/18

Interventions Technique and timing
  1. Bolus intravenous injections of dexketoprofen, paracetamol, metamizole or 0.9% saline were given at skin closure and repeated every 8 hours in the dexketoprofen and every 6 hours in the paracetamol, metamizole and control groups.


Dosage
  1. Group 1: dexketoprofen 50 mg

  2. Group 2: paracetamol 1 gram

  3. Group 3: metamizole 1 gram

  4. Group 4: saline control: not reported

Outcomes Primary
  1. Pain in the first 24 hours postoperatively as measured by the visual analogue score (measured at 1, 2, 6, 12 and 24 hours)


Secondary
  1. Postoperative morphine consumption

  2. Adverse events: nausea and vomiting, pruritis, rash

Notes Funding
None
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: ''patients were randomised to one of four groups using opaque envelopes.'' However, it was not clear how the envelopes were selected to ensure random allocation.
Allocation concealment (selection bias) High risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: ''the study drugs that were dissolved in 100 mL 0.9% saline solution were prepared by a nurse and administered by another nurse whereas postoperative data were collected by a blinded anaesthesiologist''.
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Postoperative data was collected by a blinded anaesthesiologist.
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk 8 participants were excluded from the analysis.
1 participant: could not be extubated at the end of surgery (did not state which group he or she was in)
2 participants: did not regain consciousness at the end of surgery (both in the metamizol group)
3 participants: suffered seizures (1 in the dexketoprofen group and 2 in the paracetamol group)
2 participants: required merperidine for postoperative shivering (both in the saline control group)
Selective reporting (reporting bias) Low risk Outcomes reported as specified
Other bias Unclear risk Small study