Aims & Objectives:
To compare the efficacy and safety of low dose against standard dose insulin in the treatment of pediatric diabetic ketoacidosis (DKA).
Design and Setting: Randomized, double-blind-controlled superiority clinical trial was-conducted in pediatric critical care division of a tertiary care academic institute from Oct-2014 to June-2017. Subjects: Children aged ≤12-year with DKA as per ISPAD-2014 guideline.Children with septic shock and inborn error of metabolism were excluded. Intervention: Low dose(0.05U/kg per hour) vs.standard dose(0.1 U/kg per hour) insulin infusion. Main outcome measures: Primary: Time to resolution of DKA (pH ≥7.3, bicarbonate ≥15mEq/L, BOHB <1 mmol/L). Secondary: the rate of fall to BG ≤250 mg/dL and complications (hypokalemia, hypoglycemia and cerebral edema).
Sixty patients (mean±SD age of 94.7 ± 41.4 months) were randomized to standard dose(n=30) and low dose(n=30) groups. Intention to treat analysis (n=60) was done. Mean±SD time taken to achieve the resolution of DKA was similar in standard vs. low dose group(23.4 ± 17.8 vs. 24.3 ± 12.2 hours;p=0.822). Mean±SD rate of fall in blood glucose to ≤250 mg/dL (59.5 ± 27.6 vs.48.2 ± 30.5 mg/dL/hour; p=0.148) and time taken to achieve this target was also similar (6.4 ± 4.1 vs.5.1 ± 3.4; p=0.206). Complications were similar in both the groups[(hypokalemia 14 (47%) vs. 16 (53%);p=0.606) and hypoglycemia 5(17%) vs. 2(7%);p=0.424)]. No patient developed cerebral edema during the therapy.
In pediatric DKA management, low dose and standard dose insulin therapy were associated with similar clinical and biochemical improvement with comparable complications.(CTRI/2014/08/004823).