Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Sedative weaning protocol We create the new sedative weaning protocol and then use the sedative weaning protocol. |
Other: The sedative weaning protocol group
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.
|
| Placebo Comparator: Usual Care no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician |
Other: The usual group
After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician
|
Outcome Measures
Primary Outcome Measures
- incidence of withdrawal symptom [72 hour]
Secondary Outcome Measures
- length of PICU stay [30 days]
- sedation related adverse events [7 days]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients aged 1 mo to 18 yrs, at least 37 week of postmenstrual age
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Patient who was admitted in PICU or intermediate ward at Ramathibodi hospital
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use analgesic/sedative drugs (parenteral)≥ 3 days
Exclusion Criteria:
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Patients in whom level of sedation or withdrawal assessment cannot be scored.
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Patients transferred from other hospitals in which the patients have already presented of withdrawal symptoms
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patient/parent refuse this study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Pediatric,Ramathibodi Hospital | Bangkok | Thailand | 10400 |
Sponsors and Collaborators
- Ramathibodi Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ID125808