Key result
Pediatric patients achieving satisfactory sedation with clonidine lollipops had significantly higher plasma clonidine concentrations (0.45 ng/ml) compared to those with unsatisfactory sedation (0.26 ng/ml).
Why the study?
Does a specific plasma concentration of clonidine lollipop provide satisfactory pre-operative sedation without hemodynamic changes in pediatric patients?
RCT (n=16)
Randomly assigned to 2 or 4 mg/kg
No
Does a specific plasma concentration of clonidine lollipop provide satisfactory pre-operative sedation without hemodynamic changes in pediatric patients?
Absolute Event Rate: 0.45% vs 0.26%
p-value: p=<0.05
A plasma clonidine concentration of 0.3-0.8 ng/ml achieved via lollipop administration provides satisfactory pre-operative sedation in pediatric patients without significant hemodynamic changes.
Supports targeting plasma clonidine 0.3-0.8 ng/ml for effective pediatric pre-op sedation; extends RCT evidence for lollipop formulation.
Clonidine hydrochloride has been used for pre-anesthetic medication to provide a pre-operative sedation in pediatric surgery. The purpose of this study is to determine the plasma clonidine concentration, which gives satisfactory sedation in pediatric surgery. Sixteen pediatric patients (age: 1-11 years, weight: 9-33 kg) received either 2 or 4 microg/kg of clonidine lollipop before entering the operating room. Plasma clonidine concentrations were determined 120 min after administration of clonidine lollipop. Pre-operative sedation was evaluated by 5-point scoring systems at entering the operating room. The changes in systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were also assessed before and after administration of clonidine lollipop. The patients with satisfactory sedation had higher plasma clonidine concentration than that of the patients with unsatisfactory sedation (0.45+/-0.16 ng/ml vs. 0.26+/-0.16 ng/ml, p<0.05). The clonidine concentrations in the satisfactory group ranged from 0.28 to 0.81 ng/ml. There was no significant difference in hemodynamic parameters (SBP, DBP and HR) before and after administration of clonidine lollipop in both satisfactory and unsatisfactory sedation groups. Plasma clonidine concentration of 0.3-0.8 ng/ml would be sufficient to produce satisfactory sedation without changes in hemodynamic parameters in pediatric surgery.
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Sumiya et al. (2003) conducted an RCT in Pre-operative sedation in pediatric surgery (n=16). Clonidine lollipop vs. Unsatisfactory sedation group was evaluated on Plasma clonidine concentration in satisfactory vs unsatisfactory sedation groups (p=<0.05). Pediatric patients achieving satisfactory sedation with clonidine lollipops had significantly higher plasma clonidine concentrations (0.45 ng/ml) compared to those with unsatisfactory sedation (0.26 ng/ml).
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