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NCT Number: NCT03018977

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

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.

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Key information

Conditions

Withdrawal Syndrome Chemically-Induced Disorders Mental Disorders Substance Withdrawal Syndrome Substance-Related Disorders

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric,Ramathibodi Hospital

Bangkok, 10400, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

The sedative weaning protocol group

Other

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 group

Other

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

Primary outcomes

  1. incidence of withdrawal symptom

    Time frame: 72 hour

Secondary outcomes

  1. length of PICU stay

    Time frame: 30 days

  2. sedation related adverse events

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2017
Registry last updated
Apr 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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