Effect of promethazine in cleft surgeries among Indian children

The use of antihistamine therapy in children for the management of upper respiratory tract infections remains a topic of debate. In this study, we focused on evaluating the effectiveness of promethazine (Phenergan), a first-generation H1 receptor antagonist and sedative, in addressing preoperative and intra-operative sequelae in cleft surgeries. A single-centered, parallel, randomized, double-blinded controlled clinical trial was conducted on 128 children aged 2 to 4 years undergoing cleft palate surgery under general anesthesia. The case group received Phenergan syrup orally twice a day for three days, while the control group received a placebo. Primary outcomes measured preoperative anxiety levels using a children's fear scale, while secondary outcomes assessed preoperative sleep quality and cough rate through objective scales. Intraoperative heart rate was monitored using an ECG connected to a monitor. The results demonstrated that the administration of promethazine resulted in a 34% reduction in anxiety levels, a 46% reduction in cold and cough, a 38% improvement in sleep score, and stable heart rates throughout the surgery compared to the control group. Based on these findings, promethazine is considered a safe premedication option for children undergoing cleft palate surgeries; given its benefits outweigh its adverse effects.