Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial

Abstract

Aims The prolonged use of benzodiazepines and opioids can lead to an increase in the incidence of withdrawal syndrome. One of the known risk factors is the lack of a sedative-weaning protocol. This study established a sedative-weaning protocol and compared this protocol with the usual care of weaning in high-risk critically ill children. Materials and methods This was an open-label, randomized controlled trial in a tertiary-care hospital. We recruited children aged 1 month to 18 years who had received intravenous sedative or analgesic drugs for at least 5 days. The exclusion criteria were patients who had already experienced the withdrawal syndrome. We established a weaning protocol. Eligible patients were randomly divided into the protocolized (intervention) and usual care (control) groups. The primary objective was to determine the prevalence of the withdrawal syndrome compared between two groups. Results Thirty eligible patients were enrolled (19 in the intervention and 11 in the control group). Baseline characteristics were not significantly different between both the groups. The prevalence of the withdrawal syndrome was 84% and 81% of patients in the intervention and control group, respectively. The duration of the initial weaning phase was shorter in the intervention group than in the control group ( p value = 0.026). The cumulative dose of morphine solution for rescue therapy in the intervention group was statistically lower than that in the control group ( p value = 0.016). Conclusion The implementation of the sedative-weaning protocol led to a significant reduction in the percentage of withdrawal days and length of intensive care unit stay without any adverse drug reactions. External validation would be needed to validate this protocol. ClinicalTrials.gov identifier NCT03018977 How to cite this article Tiacharoen D, Lertbunrian R, Veawpanich J, Suppalarkbunlue N, Anantasit N. Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial. Indian J Crit Care Med 2020;24(6):451–458.

Strategies for the management and prevention of withdrawal syndrome in critically ill pediatric patients: a systematic review

“…Of the 12 selected studies, four were RCTs; ( 19 - 22 ) three were NRCTs; ( 8 , 23 , 24 ) and five were observational studies. ( 25 - 29 ) All studies were conducted in pediatric ICUs.…”

“…Seven RCTs ( 19 - 22 ) and NRCTs ( 8 , 23 , 24 ) were observed in the control and intervention groups. Five of them had weaning according to medical/conventional criteria in the control group, and the intervention group had a weaning protocol.…”

“…Five of them had weaning according to medical/conventional criteria in the control group, and the intervention group had a weaning protocol. ( 8 , 19 , 22 - 24 ) One of them ( 20 ) evaluated the control and intervention groups using dexmedetomidine. For the management and prevention of withdrawal syndrome, there was only one patient who presented was administered a placebo versus clonidine.…”

“…Five studies were included in this category ( Table 3 ). Of these, three dealt with the evaluation of protocols by risk stratification in the occurrence of withdrawal syndrome ( 8 , 22 , 24 ) based on the time of exposure to benzodiazepines and opioids, and one of them evaluated sedation and analgesia using scales. ( 23 ) Another analyzed the occurrence of withdrawal syndrome using a medication rotation protocol.…”

“…The Withdrawal Assessment Tool 1 (WAT-1), an instrument intended for the assessment of withdrawal syndrome, was the most used and was present in three of the four studies. ( 8 , 22 , 24 )…”