Premedication with melatonin vs midazolam in anxious children.

AIM: Failure of dental treatment caused by anxiety is a common problem in children. Oral midazolam has been the most commonly used premedication for pediatric patient but the use of midazolam may be associated with paradoxical reactions in children. Melatonin may induce a natural sleepiness and improve sedation. We have investigated premedication with melatonin compared with midazolam in children under nitrous oxide/oxygen (N(2)O/O(2)) sedation for dental treatment. METHODS: In a randomized study, 60 children received either 3 mg of melatonin [Melatonina (3 mg(R)) 60 min before the procedure (n = 15); group I], 0.5 mg.kg(-1) melatonin 60 min before the procedure (n = 15; group II), 0.75 mg.kg(-1) midazolam [Dormicum (15 mg/3 ml (R)) 15 min before the procedure (n = 15); group III] or 3 ml of 0.09 NaCl 15 min (n = 7) or 60 min before the procedure (n = 8; group IV) orally. The children were sedated with 40/60% N(2)O/O(2) inhalation. The heart rate and O(2) saturation were monitored during the treatment period. The level of sedation was assessed according to the Ramsay Sedation Scale. The children's sedation success during dental treatment was classified. The sedation success and other sedation-related events recorded. Comparisons among the four groups were made using one-way anova or Kruskal-Wallis test, and if any significant differences were noted, the Tukey's HSD or Mann-Whitney U-test were used for intergroup comparisons. All differences were considered significant at P < 0.05. RESULTS: The evaluation of sedation success was as follows: group I: satisfactory (n = 1), average satisfactory (n = 4), and unsatisfactory (n = 10); group II: satisfactory (n = 2), average satisfactory (n = 3), and unsatisfactory (n = 10); group III: satisfactory (n = 9), average satisfactory (n = 6); and group IV: satisfactory (n = 1), average satisfactory (n = 3), and unsatisfactory (n = 11). CONCLUSION: In these doses and clinical conditions, melatonin was similar to that of placebo and did not contribute to N(2)O/O(2) sedation of anxious children.