Babita Ghai1, Radhika Prasad Grandhe, Arun Kumar, Pramila Chari. 1. Department of Anaesthesia and Intensive Care, Post Graduate Institute of Medical Education and Research, (PGIMER), Chandigarh, India. ghaibabita@hotmail.com
Abstract
BACKGROUND: Oral premedication with midazolam and ketamine is widely used in pediatric anesthesia to reduce emotional trauma and ensure smooth induction. However, various dosing regimens when used alone or in combination have variable efficacy and side effect profile. The aim of our study was to investigate and compare the efficacy of oral midazolam alone with a low-dose combination of oral midazolam and ketamine. METHODS: We performed a prospective randomized double-blind study in 100 children who were randomly allocated into two groups. Group M received 0.5 mg.kg(-1) oral midazolam and group MK received 0.25 mg.kg(-1) oral midazolam with 2.5 mg.kg(-1) oral ketamine. The preoperative sedation score, ease of parental separation and ease of mask acceptance were evaluated on a 4-point scale. The time to recovery from anesthesia and to achieve satisfactory Aldrete score was also noted. RESULTS: Uniform and acceptable sedation scores were seen in both the groups (group M 95.9%; group MK 97.96%), without any serious side effects. However, the combination offered significantly more children in an awake, calm and quiet state, who were easily separated from their parents (73.46% in MK vs 41% in group M). The induction scores were comparable between the groups. The recovery room characteristics and time to achieve satisfactory Aldrete score were also comparable between the two groups. CONCLUSIONS:Oral midazolam alone and a combination of midazolam with ketamine provide equally effective anxiolysis and separation characteristics. However, the combination provided more children in an awake, calm and quiet state who could be separated easily from parents.
RCT Entities:
BACKGROUND: Oral premedication with midazolam and ketamine is widely used in pediatric anesthesia to reduce emotional trauma and ensure smooth induction. However, various dosing regimens when used alone or in combination have variable efficacy and side effect profile. The aim of our study was to investigate and compare the efficacy of oral midazolam alone with a low-dose combination of oral midazolam and ketamine. METHODS: We performed a prospective randomized double-blind study in 100 children who were randomly allocated into two groups. Group M received 0.5 mg.kg(-1) oral midazolam and group MK received 0.25 mg.kg(-1) oral midazolam with 2.5 mg.kg(-1) oral ketamine. The preoperative sedation score, ease of parental separation and ease of mask acceptance were evaluated on a 4-point scale. The time to recovery from anesthesia and to achieve satisfactory Aldrete score was also noted. RESULTS: Uniform and acceptable sedation scores were seen in both the groups (group M 95.9%; group MK 97.96%), without any serious side effects. However, the combination offered significantly more children in an awake, calm and quiet state, who were easily separated from their parents (73.46% in MK vs 41% in group M). The induction scores were comparable between the groups. The recovery room characteristics and time to achieve satisfactory Aldrete score were also comparable between the two groups. CONCLUSIONS: Oral midazolam alone and a combination of midazolam with ketamine provide equally effective anxiolysis and separation characteristics. However, the combination provided more children in an awake, calm and quiet state who could be separated easily from parents.