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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03018977
Enrollment
60
Registered
2017-01-12
Start date
2017-01-31
Completion date
2018-04-30
Last updated
2018-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Withdrawal Syndrome

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.

Interventions

OTHERThe 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.

OTHERThe usual group

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

Sponsors

Ramathibodi Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
incidence of withdrawal symptom72 hour

Secondary

MeasureTime frame
length of PICU stay30 days
sedation related adverse events7 days

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026