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

Withdrawal Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03018977
• Other study ID #: ID125808
• Status: Completed
• Phase: N/A
• First received: January 11, 2017
• Last updated: April 10, 2018
• Start date: January 2017
• Est. completion date: April 2018

Study information

• Verified date: April 2017
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Substance Withdrawal Syndrome
• Withdrawal Syndrome

Intervention

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.
• The usual group
After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician

Locations

Country	Name	City	State
Thailand	Department of Pediatric,Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of withdrawal symptom		72 hour
Secondary	length of PICU stay		30 days
Secondary	sedation related adverse events		7 days