Preoperative 15 mg of melatonin for reducing anxiety and post-traumatic stress disorder symptoms in mandibular third molar surgery: A randomized double-blind placebo-controlled clinical trial

BACKGROUND This study evaluated the efficacy of a single 15 mg preoperative sublingual dose of melatonin in reducing anxiety as the primary outcome, and its effects on psychomotor performance, postoperative sleep quality, and early post-traumatic stress symptoms as secondary outcomes in patients undergoing mandibular third molar surgery.

MATERIAL AND METHODS Forty-eight patients were randomly allocated to receive either melatonin (n=24) or an identical placebo (n=24) sublingually 45 minutes before surgery. Anxiety was assessed using the State-Trait Anxiety Inventory (STAI) and a Visual Analog Scale for Anxiety (VAS-A) at baseline, 45 minutes post-medication, and post-surgery. Intraoperative anxiety was measured with the surgeon-rated Interval Scale of Anxiety Response (ISAR). Psychomotor performance was evaluated with the Digit Symbol Substitution Test (DSST) at baseline and 45 minutes post-medication. Sleep quality was recorded via a patient diary for three postoperative nights, and post-traumatic stress symptoms were screened one week post-surgery using the Impact of Event Scale-Revised (IES-R).

RESULTS After adjusting for baseline scores using ANCOVA and GLM, no significant effect of melatonin was observed on state anxiety at any time point. Regarding secondary outcomes, no significant differences were observed in psychomotor performance, intraoperative anxiety from the surgeon's perspective (ISAR), postoperative sleep quality across the three nights, or early post-traumatic stress symptoms. The intervention was well tolerated, with no adverse events reported.

CONCLUSIONS A single 15 mg preoperative dose of sublingual melatonin did not demonstrate any significant benefit over placebo in reducing perioperative anxiety, improving psychomotor performance, enhancing postoperative sleep quality, or preventing early post-traumatic stress symptoms in patients undergoing mandibular third molar surgery.