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

Primary Purpose

Withdrawal Syndrome

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
The sedative weaning protocol group
The usual group
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Withdrawal Syndrome

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Pediatric,Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Sedative weaning protocol

Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

incidence of withdrawal symptom

Secondary Outcome Measures

length of PICU stay
sedation related adverse events

Full Information

First Posted
January 11, 2017
Last Updated
April 10, 2018
Sponsor
Ramathibodi Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03018977
Brief Title
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

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2017 (undefined)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
April 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Withdrawal Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sedative weaning protocol
Arm Type
Active Comparator
Arm Description
We create the new sedative weaning protocol and then use the sedative weaning protocol.
Arm Title
Usual Care
Arm Type
Placebo Comparator
Arm Description
no use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician
Intervention Type
Other
Intervention Name(s)
The sedative weaning protocol group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
The usual group
Intervention Description
After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician
Primary Outcome Measure Information:
Title
incidence of withdrawal symptom
Time Frame
72 hour
Secondary Outcome Measure Information:
Title
length of PICU stay
Time Frame
30 days
Title
sedation related adverse events
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Pediatric,Ramathibodi Hospital
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
32863639
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.
Results Reference
derived

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

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