Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03018977
• Date of registration: 11/01/2017
• Prospective Registration: No
• Primary sponsor: Ramathibodi Hospital
• Public title: Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT
• Scientific title: Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial
• Date of first enrolment: January 2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03018977
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Thailand

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients aged 1 mo to 18 yrs, at least 37 week of postmenstrual age

- Patient who was admitted in PICU or intermediate ward at Ramathibodi hospital

- use analgesic/sedative drugs (parenteral)= 3 days

Exclusion Criteria:

- Patients in whom level of sedation or withdrawal assessment cannot be scored.

- Patients transferred from other hospitals in which the patients have already presented
of withdrawal symptoms

- patient/parent refuse this study



Age minimum: 1 Month
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Withdrawal Syndrome

Intervention(s)

Other: The sedative weaning protocol group

Other: The usual group

Primary Outcome(s)

incidence of withdrawal symptom [Time Frame: 72 hour]

Secondary Outcome(s)

sedation related adverse events [Time Frame: 7 days]

length of PICU stay [Time Frame: 30 days]

Secondary ID(s)

ID125808

Source(s) of Monetary Support

Please refer to primary and secondary sponsors