Oral ketamine plus midazolam Vs. Oral chloral hydrate as a sole sedative agent for short diagnostic radiological procedure in pediatric patient : a blinded, randomized (1:1) controlled trial

Abstract

Objective: To examine the efficacy and safety of oral ketamine plus midazolam as a sedative regimen in compare with oral chloral hydrate during non painful, short diagnostic radiological procedure in pediatric patient. Design: Randomized, double blinded, controlled trial. Setting: Department of Radiology, Siriraj Hospital, Faculty of Medicine, Mahidol University. Method: Ninety three pediatric patients, aged 1-3 years, scheduled for short nonpainful diagnostic radiological procedure lasting less than 30 minutes were enrolled and assigned to group I [oral ketamine 10 mg/kg plus midazolam 1 mg/kg (KM), n=47] and group II [oral chloral hydrate 75 mg/kg (C), n=46]. Vital signs, sedation score, acceptance of oral medication, reaction response to stimuli (IV placement, separation from parent), sedation onset, recovery and discharge time, scan picture quality, amount of propofol needed, cardiorespiratory changes, side effects were recorded and compared between the studied groups. Results: There was no statistically significant difference between the success rate of KM in compare with C (71.1% vs 69.9%, P=1.000) while patients in the KM group expressed less reaction to IV placement (P = 0.002) and retaining urine catheter (P = 0.075). Even though KM had a significant faster sedation onset (drowsiness, KM: 10.1+-6.3; C: 13.5+-6.9 minutes, P = 0.021 and sleep, KM:15.9+-7.4; C: 20.4+-8.1 minutes, P = 0.009) but it had a significant longer recovery time (KM: 152.9+-64.8; C: 105.3+-34.2 minutes, P<0.001) and discharge time (KM: 186.5+-72.5; C: 117.8+-35.3 minutes, P<0.001) as well as more cardiorespiratory depression especially when propofol was added. KM also produced more side effects ie., nystagmus, hiccup, nausea, vomiting, ataxia, confusion , mild hypoxemia and less parents' satisfaction. Conclusion: Oral ketamine plus midazolam is a sedative regimen that could not provide more successful sedation than oral chloral hydrate. Even though this regimen had faster onset, and patient appeared to be more tolerable to external stimuli but it had longer recovery and discharge time along with more side effects