| Background:The optimal sedative for children with dental anxiety,which provides the greatest effect with the lowest risk,has not been identified.Midazolam is a commonly used sedative in pediatric dentistry.In addition to oral administration,midazolam can also be administered intramuscularly,nasally or rectally.At present,there are few studies comparing sedative effectiveness of oral or intramuscular midazolam during dental treatment of children with dental anxiety.However intranasal dexmedetomidine is increasingly used in this clinical setting.But the efficacy of combined treatment with dexmedetomidine and midazolam in dental sedation is not yet known.Purpose:The first part:This trial evaluated the sedative effectiveness of oral or intramuscular midazolam during dental treatment of children with dental anxiety.The second part:This trial compared the sedative effectiveness of oral midazolam alone to that of intranasal dexmedetomidine plus oral midazolam during dental treatment of children with dental anxiety.Materials and methods:1.From January 2020 to July 2020,90 children who received midazolam sedation in the Stomatology Department of Shenzhen Children’s Hospital were randomly divided into two groups,45 in each group.Midazolam was given intramuscularly(0.2 mg/kg)in the intramuscular group and orally(0.6 mg/kg,maximum single dose 20.0 mg).Sedation effectiveness was assessed with the Ramsay Scale,treatment compliance with the Frankl Scale,and treatment completion with the Houpt Scale.At the same time,the onset time of drugs,heart rate,blood oxygen saturation,intraoperative and postoperative adverse reactions were recorded.2.From August 2020 to December 2020,in total,83 children(aged 3–12 years)scheduled to undergo dental sedation were randomized into two groups:oral midazolam(M group)and intranasal dexmedetomidine plus oral midazolam(DM group).Sedation status,onset time,treatment acceptance,hemodynamic parameters,and recovery conditions were recorded by an observer.The primary outcomes were the sedation status and the rate of successful sedation for dental treatment.Secondary outcomes were adverse events during and after treatment.Data analyses involved descriptive statistics and nonparametric tests.Results:1.The onset time of the intramuscular group(13.0±2.0min)was significantly shorter than the oral group(15.6±1.8min),and the difference was statistically significant(t=6.489,P<0.05).The median scores of the Ramsay(Z=-1.089,P=0.276),Frankl(Z=-0.0863,P=0.388)and Houpt scales(Z=-1.854,P=0.064)were not statistically significant,and the distribution of scores was similar(P<0.05).There was no significant difference in the sedation success rate(χ~2=0.178,P>0.05)and treatment success rate(χ~2=3.103,P>0.05)between the two groups.And there was no significant difference in the incidence of side effects(χ~2=0.080,P>0.05).2.Patient behavior during sedation was better in the DM group.However,the sedation onset time was significantly longer in the DM group(17.5±2.4 min)than in the M group(15.7±1.8).There was significant difference in the median score of Ramsay scale(Z=-4.176,P=0.000),Frankl scale(Z=-2.646,P=0.008)and Houpt scale(Z=-2.134,P=0.033),and the distribution of scores was not similar.In total,21 of 43 patients(48.8%)were successfully sedated in the M group,compared to 31 of 40(77.5%)children in the DM group.No children required medical intervention or oxygen therapy for hemodynamic disturbances,and the incidences of adverse events were similar between groups.Conclusion:Oral midazolam plus intranasal dexmedetomidine,intramuscular midazolam or oral midazolam alone are safe and effective sedation methods with a low incidence of adverse reactions.Oral or intramuscular midazolam has similar sedative effectiveness,and both of them are safe and effective sedation methods during dental treatment of children with dental anxiety.Combined treatment with oral midazolam and intranasal dexmedetomidine is more effective for managing the behavior of non-cooperative children during dental treatment,compared to oral midazolam alone.Combined treatment involving dexmedetomidine and midazolam produced greater sedation success with a deeper level of sedation and similar adverse event rate,although its onset time was prolonged... |
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