Related Experiment Videos
Premedication of children with oral midazolam
C O McMillan1, I A Spahr-Schopfer, N Sikich
1Department of Anaesthesia, Hospital for Sick Children, University of Toronto, Ontario, Canada.
Insights
Oral midazolam is a safe and effective premedication for children undergoing ambulatory surgery. The 0.5 mg.kg-1 dose provides optimal sedation and anxiolysis without increased side effects compared to higher doses.
Area of Science:
- Pediatric Anesthesiology
- Pharmacology
- Ambulatory Surgery
Background:
- Premedication in pediatric surgery aims to reduce anxiety and facilitate anesthesia induction.
- Oral midazolam is a commonly used sedative and anxiolytic agent.
- Optimizing dosage for safety and efficacy in young children is crucial.
Purpose of the Study:
- To evaluate the safety, efficacy, and feasibility of oral midazolam premedication in children aged 1-6 years.
- To compare different doses of oral midazolam (0.5, 0.75, 1.0 mg.kg-1) against a placebo.
- To assess the impact of premedication on sedation, anxiolysis, vital signs, and recovery time.
Main Methods:
- Randomized, double-blind, placebo-controlled trial involving 80 children (ASA PS I or II).
- Children received oral midazolam (0.5, 0.75, 1.0 mg.kg-1) or placebo 30 minutes before parental separation.
- Monitoring included heart rate, blood pressure, oxygen saturation, respiratory rate, sedation, and anxiolysis scores.
Main Results:
- Oral midazolam significantly improved sedation and anxiolysis compared to placebo, with 80-90% excellent anxiolysis at separation.
- No significant changes in vital signs or respiratory rate were observed across groups.
- Higher midazolam doses (0.75 and 1.0 mg.kg-1) did not offer additional benefits but increased side effects like loss of balance and dysphoria.
- Hospital discharge times were similar for all groups.
Conclusions:
- Oral midazolam 0.5 mg.kg-1 is a safe and effective premedication for pediatric ambulatory surgery.
- Higher doses of 0.75 and 1.0 mg.kg-1 provide no added benefit and are associated with more adverse effects.
- The 0.5 mg.kg-1 dose is recommended for optimal risk-benefit balance in this population.
Abstract:
In a randomized, double-blind, placebo-controlled study, the safety, efficacy and feasibility of oral midazolam premedication in children were evaluated in an ambulatory surgery unit. Eighty unmedicated children (ASA PS I or II, ages 1-6 yr) were randomly assigned to one of four groups receiving midazolam 0.5, 0.75, or 1.0 mg.kg-1 or a placebo 30 min before separation from parents. Heart rate, systolic blood pressure, arterial oxygen saturation, respiratory rate, sedation and anxiolysis scores were recorded before premedication, every five minutes for 30 min and then during induction of anaesthesia and recovery. We found that heart rate, systolic blood pressure, arterial oxygen saturation and respiratory rate were unchanged during the study. Sedation and anxiolysis scores in the midazolam-treated groups were greater than those in the placebo group and that anxiolysis at the time of separation from the parents was judged excellent in 80-90% of the children who received midazolam. However, sedation and anxiolysis did not differ among the three midazolam groups. Mean times to discharge from hospital were similar for all four groups. The side effects, loss of balance and head control, blurred vision and dysphoric reactions were observed only in the 0.75 and 1.0 mg.kg-1 midazolam groups. We conclude that oral midazolam 0.5 mg.kg-1 is a safe and effective premedication and that 0.75 and 1 mg.kg-1 while offering no additional benefit, may cause more side effects.