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Introduction: The lumbar puncture is one of the most important diagnostic and therapeutic procedures within children which child’s non-cooperativeness and procedural sedation are regarded necessary to conduct it. This study aimed to compare efficacy and safety of melatonin and gabapentin in reducing anxiety and pain of lumbar puncture in children. Methods: In a parallel single-blinded randomized clinical trial, sixty children aged 6 months -7 years, were evaluated in Pediatric Ward of Shahid Sadoughi Hospital, in Yazd (Iran) in 2012. The children were distributedrandomly into two groups (30 children in each group). In group one, they received 0.3 mg/kg/dose of melatonin and theother group received 15 mg/kg/dose of gabapentin. Primary endpoints were success rate in reducing anxiety (anxiety score of≥ four) and reducing pain when the needle was inserted to skin for lumbarpuncture (pain score of less than four). The clinicalside effects were investigated as well. Results: Twenty two girls (36.7%) and 38 boys (63.3%) with mean age of 2.79 ± 1.92 years were evaluated. Anxiety reduction (achieving the anxiety score of ≥ four) was obtained in 43.3% in melatonin and in 36.7% in gabapentin groups, respectively and both drugs were equally effective in anxiety reduction (p.value = 0.598).Pain reduction ( achieving the pain score of less than four) was obtained in 23.3% in melatonin and in 50% in gabapentin groups, respectively and thus, gabapentin wasproved to be more effective in pain reduction (p.value = 0.032).Mild side effects were observed in 10% of melatonin group and in 16.7% of gabapentin group. No statistically significant differences were seen from viewpoint of safety between the two drugs (p.value=0.448). Conclusion: Melatonin and gabapentin were not effective drugs in anxiety reduction for lumbar puncture of children. However, gabapentin is a safe and effective drug in pain reduction in painful diagnostic therapeutic procedures.

Keywords: Anxiety; Children; Gabapentin; Lumbar puncture; Melatonin; Pain

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