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.