Clinical trial NCT03018977: Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT
Official title: Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Withdrawal Syndrome
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2017-01-12
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: incidence of withdrawal symptom
timeFrame: 72 hour
Secondary outcomes:
measure: length of PICU stay
timeFrame: 30 days
measure: sedation related adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatric,Ramathibodi Hospital
Study officials:
References:
citation: 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.