Pilot Study for Sedation Interruption in Children

Davinia Withington

Status: Unknown

Conditions: Daily Sedative Interruption; Sedation Protocols; Sedation Strategies; Sedation; Mechanical Ventilation

Treatments: Other: Sedation Interruption Protocol; Other: Standard Sedation Protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02426320

14-011-PED

Details and patient eligibility

About

The purpose of this study is to estimate the hypothesized benefit of sedation interruption protocol on mechanical ventilation duration and PICU length of stay. The study will evaluate recruitment rates, and adherence rates of such protocol.

Full description

This is a prospective single-center, superiority, open randomized controlled trial comparing sedation interruption protocol and routine continuous sedation in mechanically ventilation (MV) children.

The study will be conducted in the twelve beds Pediatric Intensive Care Unit (PICU) at the Montreal Children's Hospital, a pediatric tertiary care and teaching hospital.

Patients will be enrolled prospectively within 24 hours of intubation and MV. After obtaining written consent patients will then be randomized to interrupted sedation or standard sedation protocol. The investigators will randomize using a computer-generated sequence of random numbers.

A Sedation protocol will be used for both groups to adjust continuous infusions of sedatives/analgesics to a targeted Comfort-Behavior scale. In the intervention group, sedation infusions will be interrupted daily at 8:00 AM, this interruption will be continued until the patient is under-sedated according to the Comfort Behavior scale goals or in the presence of symptoms of hemodynamic instability or respiratory distress. Then the patient will receive a bolus of sedation and the infusion will be restarted at a dose 50% less than the previous dose to return to the Comfort Score goal.

Enrollment: 30 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intubated and mechanically ventilated patients due to respiratory failure of multiple etiologies or after major surgical procedures for more than 24 hours.
• Sedation managed by benzodiazepines and opioids infusions

Exclusion criteria

• If sedation is required as part of medical management (Pulmonary hypertension, Increase intracranial pressure, Seizures
• Trauma & burn admissions
• Patients resuscitated from cardiac arrest
• Allergy to sedation (midazolam)
• Allergy to analgesia (fentanyl, morphine)
• Difficult airway including post-operative airway surgeries. (As deemed by ICU physician in charge)
• High frequency oscillator
• Special gas as inhaled nitric oxide, or isoflurane.
• Chronic ventilatory support
• Neuromuscular diseases
• Corrected Gestational age less than 37 weeks.
• Patients not expected to survive to discharge as per attending physician.
• Palliative care patients.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Sedation Interruption Protocol + standard sedation protocol

Active Comparator group

Description:

Nurse directed protocols for administering sedation and/or analgesia, with daily interruption of sedation/analgesia

Treatment:

Other: Sedation Interruption Protocol

Standard sedation protocol

Active Comparator group

Description:

Nurse directed protocol for administering sedation and/or analgesia.

Treatment:

Other: Standard Sedation Protocol