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

Not Applicable

Completed

• Conditions: Withdrawal Syndrome
• Interventions: Other: The usual group; Other: The sedative weaning protocol group

• Registration Number: NCT03018977
• Lead Sponsor: Ramathibodi Hospital

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.

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 Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-11
• Study First Submitted QC: 2017-01-11
• Study First Posted: 2017-01-12
• Status Verified: 2017-04
• Primary Completion: 2018-03
• Study Completion: 2018-04
• Last Update Submitted: 2018-04-10
• Last Update Posted: 2018-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	The usual group	no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician
Sedative weaning protocol	The sedative weaning protocol group	We create the new sedative weaning protocol and then use the sedative weaning protocol.

Primary Outcome Measures

Name	Time	Method
incidence of withdrawal symptom	72 hour

Secondary Outcome Measures

Name	Time	Method
sedation related adverse events	7 days
length of PICU stay	30 days

Trial Locations

Locations (1)

Department of Pediatric,Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand