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 72.8 ± 8.1, placebo 68.5 ± 7.9 Gender (M/F) in %: melatonin (55/45), placebo (50/50) ASA class: I‐III Type of surgery: cataract surgery Type of anaesthesia: topical Baseline (anxiety, pain) described: yes, no |
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Interventions | Melatonin: 10 mg Placebo Administration route: oral Time of administration: 90 min preoperatively |
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Outcomes | 1. Anxiety assessed by Verbal Anxiety Score (0 to 10) (preoperative) 2. Pain assessed by Verbal Pain Score (0 to 10) 3. Analgesic consumption by fentanyl requirements 4. Intraocular pressure (IOP) measured by Shioetz tonometer 5. Haemodynamcis (heart rate and mean arterial pressure) |
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Notes | Sample size calculation: described | |
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 1147) (Ismail 2009) |
Allocation concealment (selection bias) | Low risk | Quote: "...randomly allocated using an online research randomizer..." (page 1147) |
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 | Low risk | Quote: "an ophthalmologist who was blinded..." and "...the operating surgeon, who was blinded to patient allocation..." and "The attending anaesthesiologist who was unaware of patient group assignment..." (page 1147) |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The attending anaesthesiologist who was unaware of patient group assignment managed the patients and recorded all data" (page 1147) |