NCT03018977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 11, 2018

Status Verified

April 1, 2017

Enrollment Period

1.2 years

First QC Date

January 11, 2017

Last Update Submit

April 10, 2018

Conditions

Withdrawal Syndrome

Outcome Measures

Primary Outcomes (1)

  • incidence of withdrawal symptom

    72 hour

Secondary Outcomes (2)

  • length of PICU stay

    30 days

  • sedation related adverse events

    7 days

Study Arms (2)

Sedative weaning protocol

ACTIVE COMPARATOR

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

Other: The sedative weaning protocol group

Usual Care

PLACEBO COMPARATOR

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

Other: The usual group

Interventions

The sedative weaning protocol groupOTHER

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.

Sedative weaning protocol
The usual groupOTHER

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

Usual Care

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric,Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 32863639DERIVED

MeSH Terms

Conditions

Substance Withdrawal Syndrome

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 12, 2017

Study Start

January 1, 2017

Primary Completion

March 1, 2018

Study Completion

April 1, 2018

Last Updated

April 11, 2018

Record last verified: 2017-04

Locations

TH(1)