The Effect of Phenylephrine Nasal Drops on Surgical Bleeding in Children Underwent Cleft Palate Surgery: A Randomized Clinical Trial

Abstract

Background: Cleft lip and palate are birth defects due to a lack of proper formation of the lip or mouth. Controlling bleeding during cleft lip and palate surgeries is very important. Objectives: This study aimed to evaluate the effect of phenylephrine nasal drops on bleeding during and after cleft palate repair surgery in children. Methods: This controlled, randomized, double-blind, clinical trial was performed on 36 children aged 6 months to 2 years with cleft palate who were candidates for repair surgery. Patients were randomly divided into 2 groups of 18 patients. In the intervention group, 0.25% phenylephrine drops were poured into the nostrils, and the same amount of normal saline was poured in the control group. Changes in systolic and diastolic blood pressures, heart rate, bleeding during surgery based on the gauzes used, the volume of blood in the suction canister, and the amount of blood in the field, as well as the surgical field quality and surgeon satisfaction, were evaluated using analysis. Results: No statistically significant difference was observed between the 2 groups in terms of age, sex, weight, heart rate, and systolic and diastolic blood pressures. The mean volume of bleeding based on the total weight of gauzes used and suctioned blood during surgery showed a statistically significant difference between the intervention and control groups (P = 0.0016). The surgeon satisfaction in terms of the surgical field quality using a 5-point Likert scale showed a significant difference between the 2 groups (P = 0.0068), as well as more satisfaction in the intervention group according to the Boezaart scale (P = 0.0043). Conclusions: It seems that the use of nasal phenylephrine drops in pediatric cleft palate surgeries can significantly reduce bleeding and increase the quality of the operation field. Therefore, nasal phenylephrine drops can be used to control bleeding in this type of surgery.