A comparison of oral midazolam and ketamine with oral midazolam and promethazine in paediatric sedation

Introduction
Conscious sedation is frequently employed for the management of pre-cooperative or extremely anxious and painful procedures in emergency department paediatric patients. Many medications have been used to sedate children in the emergency department separately and in combination in an attempt to find an ideal sedation regimen. The oral route for conscious sedation is very easy to administer and has good acceptance. However, it seems that there is a need to find a drug with greater effectiveness and fewer complications. Aim of the research: To compare of oral midazolam and ketamine with oral midazolam and promethazine in sedating paediatric patients referred to the emergency department.

Material and methods
This study was a double-blinded clinical trial involving 102 children aged between 2 and 10 years, who were referred to Sari Imam Khomeini Hospital. These children did not have any contraindication for receiving sedation and were divided randomly into 2 groups. We gave oral midazolam (0.5 mg/kg) to all patients. Afterward, oral promethazine (1 mg/kg) was given to one group and oral ketamine (5 mg/kg) to the other group, both of which were mixed with fruit juice by a pharmacologist. The level of sedation, the child’s reaction during separation from his/her parents and while giving the treatment, and the intensity of the child’s crying while taking the drug and during treatment were evaluated using the Ramsay and Houpt scale. Furthermore, pain intensity measured by VAS scale, recovery duration, and possible side effects were documented by the research assistant, who was unaware of the given drugs. The data were analysed with SPSS.v19 software using the t-test, 2 test, Mann-Whitney test, and repeated measures methods.

Results
The mean and standard deviation was 5.73 ±2.73 years (in 2–10-year-old patients) in the midazolam-ketamine group and 5.59 ±2.51 years (in 2–10-year-old patients) in the midazolam-promethazine group. All of the physiological parameters in both treatment regimens were within the normal range during the sedation and treatment periods. In general, no statically significant differences were found in the physiological changes of the 2 groups. The Ramsey level of sedation was significantly higher in the midazolam-ketamine group compared to the other group (p < 0.05). Drug-induced sedation the irritability of children due to separation from their parents (p = 0.01), general reaction of children during surgery and treatment (p = 0.03), quality of analgesia measured by VAS (p < 0.001), and recovery time (p = 0.023) were all significantly better in the midazolam-ketamine group than in the midazolam-promethazine group.

Conclusions
Oral midazolam-ketamine will lead to safe and effective sedation in children, in order to perform medical procedures. Using this mixture in comparison with oral promethazine-midazolam can result in less consciousness, crying, and moving during the treatment; therefore, this will lead to less psychosomatic trauma in children and provides a quieter emergency room situation. The low price and availability of the drug as well as children’s and parents’ satisfaction because of not using a painful injection are other advantages of using these medications and this application method. Moreover, medical emergency specialists can use this desirable method to provide a less anxious and stressful situation for the patient without making long-term complications for them.