Premedication with Oral Midazolam Suppress Fentanyl- Induced Cough in Children: A Randomized Double-Blind Trial

Abstract

ABSTRACT Background Fentanyl administration is associated with fentanyl-induced cough (FIC), which can be distressing for both the patient and the medical team. Midazolam has a bronchodilator action on the smooth muscle of the airway. Aim This study aims to study the efficacy of different oral midazolam doses in controlling FIC in children. Methods A total of 120 children who underwent elective surgeries with orotracheal intubation (OTI) were involved in this randomized, double-blind, controlled study. Cases were randomized equally into three groups. Group C (control group) – received plain oral solution prepared by a pharmacist who did not participate in the study. Group MID 0.5 mg/kg – received 0.5 mg/kg of oral midazolam solution. Group MID 0.7 mg/kg – received 0.7 mg/kg of oral midazolam solution. Results Incidence of cough was 39 (97.5%) in control group, 36 (90%) in MID 0.5 mg/kg group, and 15 (6%) in MID 0.7 mg/kg group with statistically significant differences among the three groups (p < 0.001). The onset of cough was insignificantly different between the three groups (p > 0.05). Severity of cough was significantly different among the groups, with severe cases more predominant in control group followed by Group MID 0.5 while no cases suffered severe cough in Group MID 0.7 (p < 0.001). Conclusions Premedication with 0.7 mg/kg oral midazolam was superior to 0.5 mg/kg oral midazolam and placebo in suppressing FIC as evidenced by lower incidence and severity of FIC in children who underwent elective surgeries with OTI.