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Sublingual midazolam premedication in children: a dose response study
S Khalil1, L Philbrook, M Rabb
1Department of Anaesthesiology, University of Texas Medical School, Houston, USA.
Insights
Sublingual midazolam effectively sedates children before surgery. Higher doses (0.5-0.75 mg/kg) significantly improved sedation and mask acceptance compared to placebo.
Area of Science:
- Anesthesiology
- Pediatric Medicine
- Pharmacology
Background:
- Premedication is crucial for managing pediatric anxiety and facilitating anesthesia induction.
- Sublingual administration offers a non-invasive alternative to oral or intravenous routes for pediatric medications.
Purpose of the Study:
- To assess the efficacy of varying sublingual midazolam doses for pediatric premedication.
- To determine the optimal dose for achieving satisfactory sedation and improving mask acceptance in children undergoing day surgery.
Main Methods:
- A prospective, double-blind, placebo-controlled trial involving 102 children (12-129 months).
- Children received placebo or sublingual midazolam at doses of 0.25, 0.5, or 0.75 mg/kg, mixed with grape syrup.
- Sedation levels and mask induction acceptance were evaluated 15 minutes post-administration.
Main Results:
- Satisfactory sedation was observed in 28% (0.25 mg/kg), 52% (0.5 mg/kg), and 64% (0.75 mg/kg) of midazolam recipients, versus 0% for placebo.
- Higher midazolam doses (0.5 and 0.75 mg/kg) led to significantly better mask induction acceptance compared to the placebo and 0.25 mg/kg groups.
Conclusions:
- Sublingual midazolam is an effective premedication strategy in pediatric day surgery.
- Doses of 0.5 mg/kg and 0.75 mg/kg provide optimal sedation and facilitate mask induction in children.
Abstract:
The purpose of this study was to evaluate various doses of sublingual midazolam premedication in children. In our prospective, double-blind, placebo-controlled trial, children (n = 102, age range 12 to 129 months) scheduled for day surgery were randomized to receive either midazolam in one of three doses (0.25, 0.5, or 0.75 mg.kg-1) or placebo. Injectable midazolam was mixed with a thick grape syrup and placed under the tongue; the patient was asked to hold it as long as possible before swallowing. Children readily accepted the mixture. Analysing all patients randomized, none of the children receiving placebo vs 28% receiving 0.25 mg.kg-1 (P = 0.02), 52% receiving 0.5 mg.kg-1 (P < 0.001), and 64% receiving 0.75 mg.kg-1 (P < 0.001) of midazolam showed satisfactory sedation (drowsy) at 15 min after administration. Children receiving the two higher doses of midazolam (0.5 and 0.75 mg.kg-1) accepted mask induction willingly, while the group receiving 0.25 mg.kg-1 resembled the placebo group (P < 0.05).