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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 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
Interventions Melatonin: 10 mg
Placebo
Administration route: oral
Time of administration: 90 min preoperatively
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)
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)