A randomized controlled trial of sedation in the critically ill
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L Parkinson1, J Hughes, A Gill
1Department of Pharmacy, Alder Hey Children's Hospital, Liverpool, UK.
Insights
Oral chloral hydrate and promethazine effectively maintained sedation in critically ill children more than intravenous midazolam. This study highlights potential improvements in pediatric critical care sedation strategies.
Area of Science:
- Pediatric Critical Care Medicine
- Pharmacology
- Clinical Trials
Background:
- Maintenance sedation is crucial for critically ill children.
- Current sedative agents have limitations in efficacy and safety.
- Optimizing sedation protocols is essential for patient outcomes.
Purpose of the Study:
- To compare the efficacy of oral chloral hydrate and promethazine versus intravenous midazolam for maintenance sedation.
- To evaluate sedation levels using a standardized scale in critically ill pediatric patients.
- To identify more effective sedative regimens for this population.
Main Methods:
- A randomized controlled trial was conducted.
- Participants received either oral chloral hydrate/promethazine or IV midazolam.
- Sedation levels were assessed every four hours using a specialized scale.
Main Results:
- Chloral hydrate/promethazine resulted in significantly more satisfactory sedation assessments (P < 0.01).
- Midazolam group showed a higher incidence of restlessness/distress (P < 0.05).
- Overall satisfactory sedation rates were suboptimal (61% vs. 48%), indicating room for improvement.
Conclusions:
- Oral chloral hydrate and promethazine are more effective for maintenance sedation in critically ill children than midazolam.
- Sedation efficacy in this patient group can be significantly improved.
- Prospective studies on sedative drug efficacy in pediatric critical care are feasible and valuable.
Abstract:
A randomized controlled trial comparing: a) a combination of oral chloral hydrate and promethazine to b) a continuous intravenous midazolam infusion, for maintenance sedation in critically ill children, was carried out. The level of sedation was assessed four hourly using a specifically devized sedation scale. Forty-four children entered the study of whom two were subsequently excluded. The number of satisfactory assessments (desired and actual levels of sedation equal) was significantly greater in the chloral hydrate and promethazine group (Chi-squared P < 0.01; confidence intervals of the difference 0.06 to 0.20). The number of assessments at level 5 on the sedation scale (patient restless/ distressed) was significantly greater in the midazolam group (Chi-squared P < 0.05). The total number of satisfactory assessments in the two groups were only 61 and 48% respectively, suggesting that sedation can be considerably improved. Chloral hydrate and promethazine are more effective than midazolam as maintenance sedation in critically ill children. It is possible to prospectively study the efficacy of sedative drugs in critically ill children.
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