The impact of oral melatonin on pain and anxiety reduction during venipuncture in pediatric patients: a double-blind randomized clinical trial
Abstract
Background: Pain resulting from therapeutic procedures and injections is a prevalent source of stress for children. Immediate side effects of pain in infants include syncope, irritability, sleep disturbances, and nutritional issues. This study aimed to investigate the effects of oral melatonin on alleviating pain and anxiety in pediatric patients undergoing venipuncture. Methods: This double-blind, randomized controlled trial was conducted in the pediatric emergency ward. Patients were randomly assigned to one of two groups; the intervention group received 0.5 mg/kg of oral melatonin (maximum 5 mg) 30 min before venipuncture, while the placebo group received an equivalent amount of a placebo 30 min before the procedure. Using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, postcanulation fear, pain severity, compliance, and potential side effects were evaluated. Results: In total, 202 patients (113 male and 89 female) in the intervention and control groups were included in the analysis. The mean pain score during venipuncture was 1.52±3.04 in the intervention group and 2.04±6.57 in the control group (P<0.001). In the intervention group, only 19 (18.8%) patients reported pain during venipuncture, whereas 79 (78.2%) patients in the control group reported pain (P<0.001). Less than half (44.6%) of the patients in the intervention group experienced anxiety during venipuncture, while the majority (94.1%) of the patients in the control group exhibited anxiety (P<0.001).…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 202 participants or records.
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