Comparison of Nitrous Oxide-Oxygen as Inhalation Agent, Midazolam, Ketamine alone and in Combination as Oral Sedative Agents for In-office Paediatric Patients- A Randomised Control Trial

Abstract

Introduction: In-office pharmacological sedation techniques are best applied to manage an extremely fearful preschooler, especially during primary dentition or a child’s early mixed dentition period. These should be used when non pharmacological behavioural management techniques fail either due to lack of communication or in children with special care needs. Aim: To compare the efficacy of oral administrations of midazolam, ketamine, combination of midazolam-ketamine (M+K) and nitrous oxide-oxygen (N2O) inhalational sedation in achieving favorable behavioural outcome compared by using the Houpt scale in the treatment of anxious and uncooperative paediatric patients. Materials and Methods: A randomised clinical trial was conducted in the Department of Paediatric and Preventive Dentistry, SGT University, Haryana, India between September 2018 to December 2019. The study included 100 anxious children (Venham’s picture scale) aged three to five years, who required procedures under local anaesthesia administration were divided into four groups using envelop method. Each group was given either oral midazolam (M) (0.3 mg/kg) or oral ketamine (K) (3 mg/kg) or oral combination of midazolam+ketamine (M+K) (0.3 mg/kg and 2 mg/kg) or inhalational nitrous oxide-oxygen (N2O). The behaviour response of the child was recorded using the Houpt scale. The oxygen saturation level and heart rate of each patient were also recorded before, after, and during the procedure. Adverse drug reactions post-treatment was also recorded. Analysis of Variance (ANOVA), Chi-square test and Mann-Whitney U test was used for statistical analysis. Results: The study comprised of 100 anxious children (mean age was 4.1±0.5 years) requiring administration of local anaesthesia with intent to complete in-office treatment. Statistically, a significant difference was found among behaviour outcomes of four groups (p-value=0.047). Acceptable behaviour was seen best in K+M group (88%), followed by oral ketamine (K) (68%), N2O (59%), and oral midazolam (M) (52%). Adverse reactions were most commonly seen in the oral ketamine group. Conclusion: Oral M+K combination group is significantly better than oral ketamine (K), oral midazolam (M) or N2O inhalation sedation to achieve the required behaviour for dental treatment in three to five years old patients.