Efficacy and Safety of Different Doses of Midazolam Oral Solution for Cleft lip and Palate Repair in Children: A...

Area of Science:

• Pediatric Anesthesiology
• Oral Sedation Pharmacology

Background:

• Cleft lip and palate repair surgery requires effective preoperative sedation in pediatric patients.
• Optimizing sedation can improve patient cooperation, reduce anxiety, and enhance surgical conditions.

Purpose of the Study:

• To compare the efficacy and safety of two midazolam oral solution doses (0.3 mg/kg and 0.5 mg/kg) versus placebo in children undergoing cleft lip and palate repair.
• To evaluate sedation levels, mask acceptance, and emergence agitation.

Main Methods:

• A randomized controlled trial involving 74 children (4 months to 14 years) assigned to midazolam 0.3 mg/kg, 0.5 mg/kg, or normal saline.
• Assessment using Ramsay Sedation Score (RSS), Mask Acceptance Score (MAS), and Pediatric Anesthesia Emergence Delirium (PAED) scale.
• Monitoring of perioperative hemodynamics and postoperative outcomes.

Main Results:

• Both midazolam doses significantly increased RSS, reduced MAS, and lowered PAED scores compared to placebo (P < 0.05).
• The 0.5 mg/kg dose showed lower PAED scores and longer awakening/PACU times than the 0.3 mg/kg dose (P < 0.05).
• No significant differences in hemodynamic stability, extubation time, or side effects were noted across groups.

Conclusions:

• Midazolam oral solution is effective for preoperative sedation in pediatric cleft repair, enhancing mask acceptance and decreasing emergence agitation.
• The 0.5 mg/kg dose offers superior mask acceptance and sedation but may necessitate a longer recovery period.
• Midazolam oral solution represents a valuable tool for managing pediatric anxiety and cooperation during perioperative care for cleft surgery.