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Effectiveness of α2agonists for sedation in paediatric critical care: study protocol for a retrospective cohort
John C Hayden1, Ian Dawkins2,3, Cormac Breatnach2
1School of Pharmacy, Royal College of Surgeons in Ireland, Dublin, Ireland.
Insights
This study evaluates alpha2-agonists (clonidine or dexmedetomidine) as adjuncts to opioid-based sedation in mechanically ventilated children. The goal is to determine if they provide adequate sedation without increasing risks, potentially reducing opioid and benzodiazepine use.
Area of Science:
- Pediatric Intensive Care
- Pharmacology
- Clinical Anesthesiology
Background:
- Mechanically ventilated children often receive opioids and benzodiazepines for sedation, but these agents have safety concerns.
- Alpha2-agonists like clonidine and dexmedetomidine are used as alternative sedatives, yet robust evidence for their efficacy is lacking.
- Previous studies on alpha2-agonists have focused on opioid-sparing and ventilation outcomes, not sedation-specific results.
Purpose of the Study:
- To assess if an opioid-based sedation regimen with alpha2-agonist adjuncts (clonidine or dexmedetomidine) achieves non-inferior adequate sedation compared to opioid-only regimens.
- To evaluate potential additional benefits, including reduced opioid administration and decreased exposure to benzodiazepines.
- To provide evidence supporting the use of alpha2-agonists in pediatric intensive care sedation.
Main Methods:
- A retrospective cohort study design will be employed across two Irish pediatric intensive care units.
- Eligible patients are mechanically ventilated children who received an opioid infusion between January 2014 and June 2016.
- Adequate sedation, measured by the COMFORT Behaviour Score, will be compared between groups receiving alpha2-agonists versus those who did not, using propensity score matching for analysis.
Main Results:
- This section is to be filled upon study completion.
Conclusions:
- This section is to be filled upon study completion.
Introduction:
Mechanically ventilated children in paediatric intensive care units are commonly administered analgesics and sedative agents to minimise pain and distress and facilitate cooperation with medical interventions. Opioids and benzodiazepines are the most common analgesic and sedative agents but have safety concerns. The α2 agonists clonidine and dexmedetomidine are alternative sedatives in use despite neither having robust evidence to support their use. Studies evaluating effectiveness of α2 agonists to date have not focused on sedation-based outcomes instead focusing on opioid-sparing properties and ventilation outcomes. The aim of this study is to evaluate if an opioid-based sedation regimen, with an α2 agonist adjunct (clonidine or dexmedetomidine), produces a non-inferior proportion of time adequately sedated compared with a control group without an α2 agonist adjunct, while conferring potential additional benefits such as reduced opioid administration and less exposure to potential additional agents such as benzodiazepines.
Methods And Analysis:
We will conduct a retrospective cohort study in two Irish paediatric intensive care units using clinical information on patient characteristics, sedation scores and drug use. Eligible children admitted between January 2014 and June 2016 who were mechanically ventilated and received an opioid infusion will be included. Patients will be categorised into two exposure categories (received an α2 agonist or did not receive an α2 agonist) and the time adequately sedated (measured using the COMFORT Behaviour Score) will be calculated using interpolation of nursing sedation scores at each recorded time point. At least 150 per group is planned for inclusion to ensure adequate study power. Propensity score matching will be used in analysis to account for potential confounding by indication.
Ethics And Dissemination:
The study has been approved by the ethics committees of both hospitals. Dissemination will occur via local, national and international presentations for academic and healthcare audiences as well as through peer reviewed publications.
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