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

Mahidol University

Status: Completed

Conditions: Withdrawal Syndrome

Treatments: Other: The usual group; Other: The sedative weaning protocol group

Study type: Interventional

Funder types: Other

Identifiers

NCT03018977

ID125808

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups, including a placebo group

Sedative weaning protocol

Active Comparator group

Description:

We create the new sedative weaning protocol and then use the sedative weaning protocol.

Treatment:

Other: The sedative weaning protocol group

Usual Care

Placebo Comparator group

Description:

no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician

Treatment:

Other: The usual group