BACKGROUND:Melatonin has sedative, analgesic, antiinflammatory, antioxidative, and chronobiotic effects. We determined the impact of oral melatonin premedication on anxiolysis, analgesia, and the potency of the rest/activity circadian rhythm. METHODS: This randomized, double-blind, placebo-controlled study included 33 patients, ASA physical status I-II, undergoing abdominal hysterectomy. Patients were randomly assigned to receive either oral melatonin 5 mg (n = 17) or placebo (n = 16) the night before and 1 h before surgery. The analysis instruments were the Visual Analog Scale, the State-Trait Anxiety Inventory, and the actigraphy. RESULTS: The number of patients that needed to be treated to prevent one additional patient reporting high postoperative anxiety and moderate to intense pain in the first 24 postoperative hours was 2.53 (95% CI, 1.41-12.22) and 2.20 (95% CI, 1.26-8.58), respectively. The number-needed-to-treat was 3 (95% CI, 1.35-5.0) to prevent high postoperative anxiety in patients with moderate to intense pain, when compared with 7.5 (95% CI, 1.36-infinity) in the absence of pain or mild pain. Also, the treated patients required less morphine by patient-controlled analgesia, as assessed by repeated measures ANOVA (F[1,31] = 6.05, P = 0.02). The rest/activity cycle, assessed by actigraphy, showed that the rhythmicity percentual of 24 h was higher in the intervention group in the first week after discharge ([21.16 +/- 8.90] versus placebo [14.00 +/- 7.10]; [t = -2.41, P = 0.02]). CONCLUSIONS: This finding suggested that preoperative melatonin produced clinically relevant anxiolytic and analgesic effects, especially in the first 24 postoperative hours. Also, it improved the recovery of the potency of the rest/activity circadian rhythm.
RCT Entities:
BACKGROUND:Melatonin has sedative, analgesic, antiinflammatory, antioxidative, and chronobiotic effects. We determined the impact of oral melatonin premedication on anxiolysis, analgesia, and the potency of the rest/activity circadian rhythm. METHODS: This randomized, double-blind, placebo-controlled study included 33 patients, ASA physical status I-II, undergoing abdominal hysterectomy. Patients were randomly assigned to receive either oral melatonin 5 mg (n = 17) or placebo (n = 16) the night before and 1 h before surgery. The analysis instruments were the Visual Analog Scale, the State-Trait Anxiety Inventory, and the actigraphy. RESULTS: The number of patients that needed to be treated to prevent one additional patient reporting high postoperative anxiety and moderate to intense pain in the first 24 postoperative hours was 2.53 (95% CI, 1.41-12.22) and 2.20 (95% CI, 1.26-8.58), respectively. The number-needed-to-treat was 3 (95% CI, 1.35-5.0) to prevent high postoperative anxiety in patients with moderate to intense pain, when compared with 7.5 (95% CI, 1.36-infinity) in the absence of pain or mild pain. Also, the treated patients required less morphine by patient-controlled analgesia, as assessed by repeated measures ANOVA (F[1,31] = 6.05, P = 0.02). The rest/activity cycle, assessed by actigraphy, showed that the rhythmicity percentual of 24 h was higher in the intervention group in the first week after discharge ([21.16 +/- 8.90] versus placebo [14.00 +/- 7.10]; [t = -2.41, P = 0.02]). CONCLUSIONS: This finding suggested that preoperative melatonin produced clinically relevant anxiolytic and analgesic effects, especially in the first 24 postoperative hours. Also, it improved the recovery of the potency of the rest/activity circadian rhythm.