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

Study Overview
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Brief Summary
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Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned. Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital. The objectives in this study are to establish the sedative weaning protocol and to compare the protocol sedative weaning with the usual care weaning.

Detailed Description
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Sedative and analgesic agents, particularly benzodiazepines and opioids, are widely used in PICU. These agents can provide calmness, hypnotic effect, pain alleviation, cooperation, immobilization and synchronizing ventilatory support. Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned. Incidence of withdrawal syndrome is about 50%. Withdrawal syndrome can lead to unnecessary and costly diagnostic tests, prolongation of mechanical ventilation and hospital stay, and increasing of suffering. Prior study showed the longer duration of sedative drugs, cumulative dose of medications and younger age were the risk factors of withdrawal syndrome. Additional, some study showed the sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide standardized sedative weaning protocol including our hospital.

Official Title
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Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial

Conditions
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Withdrawal Syndrome

Intervention / Treatment
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* Other: The sedative weaning protocol group
* Other: The usual group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sedative weaning protocol<br>We create the new sedative weaning protocol and then use the sedative weaning protocol. | Other: The sedative weaning protocol group<br>* After physician decide to wean sedative or analgesic drugs. We divided to 2 groups including high risk group and low risk group. The sedative weaning protocol were used in these patients which rely on the high risk or low risk group.<br>|
| Placebo Comparator: Usual Care<br>no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician | Other: The usual group<br>* After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of withdrawal symptom |  | 72 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of PICU stay |  | 30 days | 
| sedation related adverse events |  | 7 days |