Oral Midazolam Alone or in Combination with Ketamine as Oral Premedication in Pediatric Ophthalmologic Surgeries

Background: Administrating premedication for children undergoing outpatient ophthalmologic procedures to reduce costs and increase efficiency is very important. The mostly used drugs for premedication are midazolam and ketamine. In this study, we compared the effectiveness of combined oral midazolam and ketamine with oral midazolam alone in outpatient pediatric ophthalmologic surgeries. Methods: In this double-blinded randomized clinical trial study, 136 children aged 6 months to 6 years undergoing outpatient ophthalmologic procedures with class I or II in American Society of Anesthesiologists (ASA) scale and without systemic disease were enrolled. Children were randomly divided in two groups. Thirty minutes before operation, group 1 received oral midazolam 0.5 mg/kg and group 2 received oral midazolam 0.25 mg/kg with ketamine 2.5 mg/kg. Medications were mixed with strawberry-flavored juice with volume of up to 0.5 ml/kg. In both groups, children’s basic behavior, acceptance of premedication, anxiolysis (30 minutes after premedication), sedation at 10, 20, and 30 minutes after premedication, parental separation behavior (30 minutes after premedication), children’s puncture behavior, number of attempts for venipuncture, puncture duration, post-anesthetic arousal stage at the end of anesthesia and recovery duration were be compared. Any complication like nausea and vomiting were also recorded. Findings: There were significant differences between two groups in sedation score and children's puncture behavior score. There were no significant differences between the two groups regarding the children’s behavior type, acceptance, anxiolysis, parental separation, and arousal stage behavior scores. Numbers of attempts for venipuncture, puncture duration and recovery variables were similar in the two groups. Nausea was seen in one child in both groups. 2 children in combination group vomited. Conclusion: Oral premedication with low dose combination of midazolam and ketamine makes earlier and more effective sedation and better puncture behavior than oral midazolam alone.