Methods | Randomized, double‐blind, placebo‐controlled study Location: Saudi Arabia Study design: parallel, 2‐armed |
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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 |
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Interventions | Melatonin: 10 mg Placebo Administration route: oral Time of administration: 90 min preoperatively |
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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) |
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Notes | Sample size calculation: described Author contacted by e‐mail on 9 August 2013 to clarify unspecified issues: no answer |
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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) |