Effectiveness of promethazine on preoperative and intraoperative sequelae in cleft palate surgeries

Area of Science:

• Pediatric Surgery
• Anesthesiology
• Pharmacology

Background:

• Cleft palate surgery in children is associated with significant preoperative anxiety and nosocomial infections.
• The use of antihistamines, like promethazine, for managing upper respiratory tract infections in children remains debated.
• Promethazine, a first-generation H1 antagonist, possesses notable sedative properties.

Purpose of the Study:

• To evaluate the effectiveness of promethazine in mitigating preoperative and intraoperative complications in pediatric cleft palate surgeries.
• To assess promethazine's impact on anxiety, sleep quality, and cough rates.
• To monitor intraoperative heart rate stability during cleft palate repair.

Main Methods:

• A single-center, parallel, randomized, double-blinded controlled trial involving 128 children aged 2-4 years undergoing cleft palate surgery.
• Participants received either promethazine syrup (1 mg/kg twice daily for 3 days) or a placebo.
• Outcomes included preoperative anxiety (Children Fear Scale), sleep quality, cough rate, and intraoperative heart rate (ECG monitoring).

Main Results:

• Promethazine administration led to a 70% reduction in preoperative anxiety levels.
• A 64% decrease in cold and cough symptoms and a 70% improvement in sleep scores were observed.
• Intraoperative heart rate remained stable throughout the surgical procedure in the promethazine group.

Conclusions:

• Promethazine is considered safe and effective as a premedication for pediatric cleft palate surgery.
• The benefits of promethazine in managing surgical sequelae outweigh potential adverse effects.
• This study supports the use of promethazine to improve patient outcomes in cleft palate repair.