Does daily interruption of sedation do better than continuous sedation in ventilated children with respect to lengths of mechanical ventilation and intensive care unit stay? Critical appraisal as per the CONSORT 2010 checklist of information of an article Randomized controlled trial of interrupted versus continuous sedative infusions in ventilated children. Gupta K, Gupta VK, Jayashree M, Singhi S. Pediatr Crit

Abstract

QuestionTo compare daily interrupted vs. continuous administration of sedative infusions in mechanically ventilated children with respect to the lengths of mechanical ventilation (MV) and intensive care unit (ICU) stay, number and percentages of day awake on MV, frequency of adverse events and dose and cost of midazolam required. MethodsThis was a prospective randomized controlled trial (RCT), conducted in the pediatric intensive care unit (PICU) of a referral and teaching hospital in North India. Included in the study were 102 patients, mechanically ventilated for >48 h from Jan, 2007 to December, 2007, including 32 patients from a pilot study, in the same unit with exactly the same methodology from June, 2004 to July, 2005. Patients who required peak inspiratory pressure (PIP) >28 mm Hg, were excluded from the study. The Institute's Ethics Committee approval and informed written consent from the parents were obtained. The patients were randomized into two groups, Group I: Continuous infusion of sedative protocol; Continued to same protocol with interruption as per the advice of the treating team. Group II: Daily interruption of sedative infusion protocol at 8.00 AM. Intravenous midazolam was given as 0.1–0.3 mg/kg bolus followed by infusion of 0.1–0.3 mg/kg/h, titrated to achieve Ramsay score of 3–4; in combination with morphine infusion by 0.01–0.03 mg/kg/h. Interruption was continued until the patient become fully awake or become agitated or uncomfortable to restart infusion again. Wakefulness was assessed as respond to verbal commands. A percentage of days out of total no of days on sedative infusion, on which the patient was awake, were recorded. Randomization by stratification was done at 48 h of ventilation, by faculty member not directly involved in the study, using computer generated numbers, to distribute patients with neuromuscular illness into both groups evenly. Participants and those administering the interventions were not blinded. Sample size was calculated assuming a failure rate of 30% in Group I; Failure rate of 10% in Group II; α error of 5%; power of 80%; 47 subjects were recruited in each group. Main resultsOf the 102 patients included in the study, 56 were randomized into the Group I and 46 into the Group II. Both the groups were similar except that the Group II had lower PIP and positive end expiratory pressure (PEEP) requirement at the start of ventilation. The mean length of MV between the Group I and II was 10.3 ± 8.4 vs. 7.0 ± 4.8 days (p = 0.021). The median length of PICU stay between the Group I and II was 14 vs. 10.7 days (p = 0.048). The mean total dose and total calculated cost of midazolam were significantly lesser in Group II compared to Group I (p = 0.002 & 0.020 respectively) (Table 1). ConclusionThe length of MV, ICU stay, total dose and cost of midazolam were significantly lesser in interrupted as compared to continuous group of sedation. This article was critically appraised as per the CONSORT 2010 checklist of information.