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Protocolized Sedative Weaning vs Usual Care in Pediatric Critically Ill Patients: A Pilot Randomized Controlled Trial
Duangtip Tiacharoen1, Rojjanee Lertbunrian2, Jarin Veawpanich2
1Division of Pediatric Critical Care, Department of Pediatrics, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Division of Pediatric Critical Care, Department of Pediatrics, Faculty of Medicine, Thammasat University Hospital, Pathumthani, Thailand.
Insights
A new sedative-weaning protocol in critically ill children reduced withdrawal days and intensive care unit stay duration. This pilot study suggests protocolized weaning is effective for pediatric patients on sedatives and analgesics.
Area of Science:
- Pediatric Critical Care Medicine
- Pharmacology
- Clinical Trial Research
Background:
- Prolonged use of benzodiazepines and opioids in critically ill children can increase withdrawal syndrome incidence.
- Lack of a standardized sedative-weaning protocol is a known risk factor for withdrawal syndrome.
- This study aimed to address this gap by establishing and evaluating a sedative-weaning protocol.
Purpose of the Study:
- To establish a sedative-weaning protocol for high-risk critically ill children.
- To compare the efficacy of this protocol against usual care in weaning children from sedative and analgesic drugs.
- To determine the prevalence of withdrawal syndrome in both groups.
Main Methods:
- An open-label, randomized controlled trial was conducted in a tertiary-care hospital.
- Children aged 1 month to 18 years, receiving intravenous sedatives/analgesics for at least 5 days, were recruited.
- Patients were randomized into a protocolized (intervention) group or usual care (control) group.
Main Results:
- The prevalence of withdrawal syndrome was high in both groups (84% intervention vs. 81% control).
- The intervention group showed a significantly shorter initial weaning phase duration (p=0.026).
- Cumulative morphine rescue dose was significantly lower in the intervention group (p=0.016).
Conclusions:
- Implementation of the sedative-weaning protocol significantly reduced withdrawal days and intensive care unit length of stay.
- No adverse drug reactions were observed with the protocolized approach.
- External validation is recommended to confirm the protocol's generalizability.
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.
Clinicaltrialsgov 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.
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