Oral Midazolam-Ketamine versus Midazolam alone for Procedural Sedation of Children Undergoing Computed Tomography; a Randomized Clinical Trial

INTRODUCTION: Motion artifacts are a common problem in pediatric radiographic studies and are a common indication for pediatric procedural sedation. This study aimed to compare the combination of oral midazolam and ketamine (OMK) with oral midazolam alone (OM) as procedural sedatives among children undergoing computed tomography (CT) imaging. METHODS: The study population was comprised of six-month to six-year old patients with medium-risk minor head trauma, who were scheduled to undergo brain CT imaging. Patients were randomly allocated to two groups: one group received 0.5 mg/kg midazolam (OM group; n = 33) orally and the other one received 0.2 mg/kg midazolam and 5 mg/kg ketamine orally (OMK group; n=33). The vital signs were monitored and recorded at regular intervals. The primary outcome measure was the success rate of each drug in achieving adequate sedation. Secondary outcome measures were the time to achieve adequate sedation, time to discharge from radiology department, and the incidence of adverse events. RESULTS: Adequate sedation was achieved in five patients (15.2%) in OM group and 15 patients (45.5%) in OMK group, which showed a statistically significant difference between the groups (p = 0.015). No significant difference was noted between OM and OMK groups with respect to the time of achieving adequate sedation (33.80 ± 7.56 and 32.87 ± 10.18 minutes, respectively; p = 0.854) and the time of discharging from radiology department (89.60 ± 30.22 and 105.27 ± 21.98 minutes, respectively; p=0.223). The complications were minor and similar among patients of both groups. CONCLUSION: This study demonstrated that in comparison with OM, OMK was more effective in producing a satisfactory level of sedation in children undergoing CT examinations without additional complications; however, none of these two regimens fulfilled clinical needs for procedural sedation.