Withdrawal SyndromeNCT03018977
Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT
A study testing The sedative weaning protocol group and The usual group in people with Withdrawal Syndrome, run by Ramathibodi Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Withdrawal Syndrome
- What is being tested?
- The sedative weaning protocol group and The usual group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2017to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Withdrawal Syndrome
- Being tested
- The sedative weaning protocol group, The usual group
- Medical subject headings
- Substance Withdrawal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
The usual groupOther
After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician
| Study group | Role | What they receive |
|---|---|---|
| Sedative weaning protocol | Active comparator | We create the new sedative weaning protocol and then use the sedative weaning protocol. Receives: 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 Receives: Other: The usual group |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of withdrawal symptom
Measured: 72 hour
Secondary outcomes (2)
length of PICU stay
Measured: 30 days
sedation related adverse events
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMar 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Anantasit, Ramathibodi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03018977
- Sponsor's protocol ID
- ID125808
- Status last verified
- Apr 2017
- First submitted
- 11 Jan 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32863639
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocolized Sedative Weaning Versus Usual Care in Pediatric Critically Ill, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03018977
- Acronym / sponsor ID
- ID125808
- Conditions
- Withdrawal Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedative weaning protocol | Active comparator | Other: The sedative weaning protocol groupWe create the new sedative weaning protocol and then use the sedative weaning protocol. |
| Usual Care | Placebo comparator | Other: The usual groupno use sedative weaning protocol. Sedative or/and analgesic medications are adjusted base on physician |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The sedative weaning protocol groupAfter 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. | Other | Sedative weaning protocol |
| The usual groupAfter physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician | Other | Usual Care |
Primary outcome
incidence of withdrawal symptom
Time frame: 72 hour
2 secondary outcomes
length of PICU stay
Time frame: 30 days
sedation related adverse events
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Derived from this study: PubMed 32863639Tiacharoen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The sedative weaning protocol group and The usual group in people with Withdrawal Syndrome, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of withdrawal symptom (time frame: 72 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03018977, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.