Daily interruption of sedation in critically ill children.

Daily interruption of sedation + protocolized sedation (DSI+PS) vs. protocolized sedation (PS) in critically ill children.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25319

Enrollment

200

Registered

2009-09-28

Start date

2009-10-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sedation, critically ill children, midazolam, morphine, pharmacokinetics, pharmacodynamics. sedatie, intensive care, midazolam, morfine, kindergeneeskunde, farmacokinetiek, farmacodynamiek.

Interventions

Patients will be randomised in two groups: 1. Daily interruption of sedative infusions and protocolized sedation (intervention group)

2. Protocolized sedation only (control group).

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 0-17 years; 2. At least 37 weeks of post conceptual age; 3. Anticipated duration of mechanical ventilation of > 48 hours; 4. Need for sedative/analgesic drugs; 5. Parental informed consent.

Exclusion criteria

Exclusion criteria: 1. Anticipated death whitin 48 hours; 2. Withdrawal of life support/DNR; 3. Patients in whom level of sedation cannot be scored with COMFORT behavior score due to neurological abnormalities; 4. Neurological, respiratory or cardiac instability that may not tolerate inadequate sedation; 5. Withdrawal of informed consent.

Design outcomes

Primary

Measure	Time frame
The number of ventilator-free days at 28 days, as defined by the number of days a patient breathes without mechanical assistance for at least 48 consecutive hours from day 1 to day 28 after randomization.	—

Secondary

Measure	Time frame
1. Safety (auto-extubation and reintubation, accidental displacement of catheters and feeding tubes, changes in blood pressure, heart rate, respiratory rate or alarms in those parameters that need medication on adjustments in ventilator settings); 2. Dosing requirements for sedative drugs; 3. Adequacy of sedation (based on scores outside of ranges); 4. Incidence of withdrawal symptoms; 5. Length of stay in the inetnsive care unit and in hospital (days); 6. 30-day mortality; 7. Costs at 28 days; 8. Incidence of posttraumatic stress disorder symptoms and quality of life at 3 months.	—

Measure

Time frame

1. Safety (auto-extubation and reintubation, accidental displacement of catheters and feeding tubes, changes in blood pressure, heart rate, respiratory rate or alarms in those parameters that need medication on adjustments in ventilator settings); 2. Dosing requirements for sedative drugs; 3. Adequacy of sedation (based on scores outside of ranges); 4. Incidence of withdrawal symptoms; 5. Length of stay in the inetnsive care unit and in hospital (days); 6. 30-day mortality; 7. Costs at 28 days; 8. Incidence of posttraumatic stress disorder symptoms and quality of life at 3 months.

—

Contacts

Public ContactM. Hoog, de

Sophia Kinderziekenhuis Intensive Care Kinderen Dr. Molewaterplein 60

m.dehoog@erasmusmc.nl+31 (0)10-7036922

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)