This study aimed to compare the effectiveness of intranasal Dexmedetomidine sedation at Dose of 2 mcg/kg and 4 mcg/kg in Children Undergoing MRI at Cipto Mangunkusumo Hospital
Ninety-four pediatric subjects who would undergo MRI with sedation were recruited. Subjects aged between 1-10 years old, ASA I-II, weighed between 1-30 kg were included in this study and assigned into two groups randomly. One group received 2 mcg/kg (IND2 group) and the other group received 4 mcg/kg (IND 4 group) of intranasal dexmedetomidine. Randomization was done by the third party, who was not participated in the data collection, by using randomization tool from www.randomizer.org. Dose of intranasal dexmedetomidine for each participant was concealed using closed envelope and was opened preprocedure by the second party who prepared the sedation drugs. The doctor, who gave sedation drug to the patient and recorded the data, was also blinded. All patients were blinded to data collection. Patients were allowed to drink clear fluid until 2 hours and required to fast for 6 hours before the procedure. Baseline heart rate, SpO2 was recorded premedication. Subjects in IND 2 and IND 4 group received 2 mcg/kg and 4 mcg/kg intranasal dexmedetomidine. Intranasal drugs were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe. Patient was maintained in supine position for 1-2 minutes to maximize absorption. After the patient was sedated, peripheral intravenous access was performed. The level of sedation was assessed using RSS. Heart rate, oxygen saturation, and RSS are recorded every 10 minutes until the procedure was done. After the target sedation has been reached, MRI started immediately. If the sedation target was not reached and/or the child moved, 0.5 mg/kg rescue dose of propofol would be given. After completing the MRI procedure, the patient was then transferred to the recovery room to record the recovery time. Outpatients were allowed to go home when they reached Aldrete score of 9-10.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
94
Intranasal dexmedetomidine were given 45 minutes before the MRI procedure through both nostrils using a 1 mL syringe.
Cipto Mangunkusumo General Hospital
Jakarta Pusat, DKI Jakarta, Indonesia
Onset sedation time of Intranasal dexmedetomidine.
This study compared the onset time of IND 2 to IND 4 group. Operational definition: Time taken from drug induction to achieve sedation (Ramsay sedation score 5). Ramsay Sedation Scoring system : 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response
Time frame: 45 minutes before MRI procedure.
Duration of Sedation
This study compared the duration of sedation of IND 2 to IND 4 group. Operational definition: Time taken from "achieving the sedation target" to "Ramsay's sedation score 3" Ramsay Sedation Scoring system : 1. Patient is anxious and agitated or restless, or both 2. Patient is co-operative, oriented, and tranquil 3. Patient responds to commands only 4. Patient exhibits brisk response to light glabellar tap or loud auditory stimulus 5. Patient exhibits a sluggish response to light glabellar tap or loud auditory stimulus 6. Patient exhibits no response
Time frame: During MRI procedure
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