Dilmen 2016.
Methods | Study design: randomized controlled trial (4 arms) Study duration: June 2013 to January 2015 Study setting: hospital, single centre, Turkey |
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Participants | Adults undergoing elective supratentorial craniotomy (n = 83) Inclusion criteria
Exclusion criteria
Mean age, range (years)
Numbers allocated to each arm
Male gender
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Interventions |
Technique and timing
Dosage
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Outcomes |
Primary
Secondary
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Notes |
Funding None |
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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 |