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Effect of promethazine in cleft surgeries among Indian children



A Vedha Vivigdha*, P Senthil Murugan, MP Santhosh Kumar, Murugesan Krishnan & Alladi Sneha



Department of Oral and Maxillofacial Surgery, Saveetha Institute of Medical & Technical Sciences (SIMATS), Saveetha University, Chennai, India; *Corresponding Author



A Vedha Vivigdha – E-mail:  Vedhaaravindan1996@gmail.com

P Senthil Murugan – E-mail: senthilmuruganp.sdc@saveetha.com

MP Santhosh Kumar – E-mail: santhoshkumar@saveetha.com

Murugesan Krishnan– E-mail: dr.mkm70@gmail.com

Alladi Sneha – E-mail: snehaalladi.0695@gmail.com



Article Type

Research Article



Received June 1, 2023; Revised June 30, 2023; Accepted June 30, 2023, Published June 30, 2023



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.



Antihistamine, craniofacial surgery, promethazine, premedication, cleft palate



Vivigdha et al. Bioinformation 19(6): 790-794 (2023)


Edited by

P Kangueane






Biomedical Informatics



This is an Open Access article which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. This is distributed under the terms of the Creative Commons Attribution License.