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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sedative weaning protocol | Active Comparator | We create the new sedative weaning protocol and then use the sedative weaning protocol. |
|
| Usual Care | Placebo Comparator | no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The sedative weaning protocol group | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of withdrawal symptom | 72 hour |
| Measure | Description | Time Frame |
|---|---|---|
| length of PICU stay | 30 days | |
| sedation related adverse events | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric,Ramathibodi Hospital | Bangkok | 10400 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32863639 | Derived | 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 Jun;24(6):451-458. doi: 10.5005/jp-journals-10071-23465. |
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| ID | Term |
|---|---|
| D013375 | Substance Withdrawal Syndrome |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| The usual group | Other | After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician |
|