Tehran University Medical Journal

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Anxiolysis and sedation with oral midazolam are common practice in pediatric anesthesia. Good or excellent results are seen in only 50% to 80% of cases, so we decided to investigate if addition of a low dose of oral ketamine to midazolam (ketamine2.5 mg /kg ^midazolam 0.25 mg/kg )resulted in better premedication compared with oral midazolam 0.5 mg/kg or ketamine 6 mg/kg alone.
Methods and Materials: in a prospective, randomized ,double -blind study we study 105 children (mean age 6 ,range 2-10 yr. ) undergoing non thoracic and non cardiac surgery of more than 30 min duration. The patients were in ASA 1, 2. After oral premedication the child's condition was evaluated by assigning 1-4 point to the quality of anxiolysis, sedation, and separation from parents in the induction room .The groups were similar in sex, age, weight, intervention and duration of anaesthesia.
Results: The score of sedation before transfer to the operation room was significantly better in the ketamine, midazolam combination group than in the ketamine or midazolam group. Success rates for anxiolysis and behavior at separation were grater than 90%with the combination, approximately 80% with midazolam and 70% with ketamine alone .The incidence of salivation, excitation, nausea and vomiting was grater in the ketamine group but were very low in other groups. During recovery there were no difference in sedation or time of possible discharge.
Conclusion: In summery, significantly better anxiolysis and separation were observed with a combination of ketamine and midazolam, even in awake children than with midazolam or ketamine alone. Duration of action and side effects of the combination was similar to those of midazolam.

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Background: Premedication is widely used in pediatric anesthesia to reduce emotional trauma and ensure smooth induction. The rectal route is one of the most commonly accepted means of drug administration. The aim of our study was to investigate and compare the efficacy of rectally administered midazolam versus that of ketamine as a premedication in pediatric patients.

Methods: We performed a prospective randomized double-blinded clinical trial in 64 children, 1 to 10 years of age, randomly allocated into two groups. The midazolam group received 0.5 mg/kg rectal midazolam and the ketamine group received 5 mg/kg rectal ketamine. The preoperative sedation scores were evaluated on a three-point scale. The anxiolysis and mask acceptance scores were evaluated separately on a four-point scale, with ease of parental separation, based on the presence or lack of crying, evaluated on a two-point scale.

Results: Neither medication showed acceptable sedation (>75%), with no significant difference in sedation score between the two groups (P=0.725). Anxiolysis and mask acceptance using either midazolam or ketamine were acceptable, with  midazolam performing significantly better than ketamine (P=0.00 and P=0.042, respectively). Ease of parental separation was seen in both groups without significant difference (P=0.288) and no major adverse effects, such as apnea, occurred in either group.

Conclusions: Rectal midazolam is more effective than ketamine in anxiolysis and mask acceptance. Although they both can ease separation anxiety in children before surgery, we found neither drug to be acceptable for sedation.