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. 2015 Apr 9;2015(4):CD009861. doi: 10.1002/14651858.CD009861.pub2
Methods Randomized, double‐blind, placebo‐controlled study
Location: Saudi Arabia
Study design: parallel, 2‐armed
Participants A total of 40 patients randomized
40 patients completed: 20 in melatonin group, 20 in placebo group
Age: melatonin 44.6 ± 11.4, placebo 42.8 ± 12.1
Gender (M/F) in %: melatonin (60/40), placebo (50/50)
ASA class: I‐II
Type of surgery: hand surgery
Type of anaesthesia: regional
Baseline (anxiety, pain) described: yes, yes
Interventions Melatonin: 10 mg
Placebo
Administration route: oral
Time of administration: 90 min preoperatively
Outcomes 1. Tourniquet‐related pain by Verbal Pain Score (0 to 10)
2. Analgesic consumption by fentanyl requirements and diclofenac consumption
3. Anxiety assessed by Verbal Anxiety Score (0 to 10) (preoperative)
4. Haemodynamics by mean arterial pressure and heart rate
5. Onset and recovery of sensory and motor blockade (minutes)
Notes Sample size calculation: described
Author contacted by e‐mail on 9 August 2013 to clarify unspecified issues: no answer
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Patients were randomly allocated using an online research randomizer..." (page 1422) (Mowafi 2008)
Allocation concealment (selection bias) Low risk Quote:"Patients were randomly allocated using an online research randomizer..." (page 1422)
Incomplete outcome data (attrition bias) All outcomes Low risk No reported dropouts or missing data
Selective reporting (reporting bias) Unclear risk Study protocol not available
Blinding of participants and personnel (performance bias) All outcomes Unclear risk Blinding of patients, surgeons or personnel not described
Blinding of outcome assessment (detection bias) All outcomes Low risk Quote: "All the evaluations were performed by a blinded observer" (page 1423)