The Comparison of the Efficacy of Early versus Late Administration of Dexmedetomidine on Postoperative Emergence Agitation in Children Undergoing Oral Surgeries: A Randomized Clinical Trial.

Background: Emergence Agitation (EA) is a dissociated state of consciousness characterized by irritability, uncompromising stance, and inconsolability. The etiology of EA is not completely understood. Dexmedetomidine is a highly selective α-adrenoreceptor agonist with sedative and analgesic properties, which has been used to reduce the incidence of EA. We aimed to assess the efficacy of early versus late administration of dexmedetomidine on EA in children undergoing oral surgery.

Methods: A randomized, parallel, double-blind clinical trial was conducted at Mofid Children's Hospital affiliated to Shahid Beheshti University of Medical Sciences (Tehran, Iran) from November 2016 to March 2017. A total of 81 children, who underwent adenotonsillectomy or cleft palate repair surgery were enrolled in the study. Based on simple randomization, the children were assigned to two groups, namely early (group A, n=41) and late (group B, n=40) administration of dexmedetomidine. Intra-operative and postoperative hemodynamic variables, extubation time, post-anesthesia care unit (PACU) length of stay, and the scores on Ramsay sedation scale and FLACC pain scale were measured and compared. The data were analyzed using SPSS software (version 20.0), and P<0.05 were considered statistically significant.

Results: The mean FLACC score was lower in the late group than in the early group (2.0±1.5 vs. 4.2±1.6, P<0.001). The mean Ramsay sedation score was higher in the late group than in the early group (3.5±1.4 vs. 1.8±0.8, P<0.001).

Conclusion: Late administration of dexmedetomidine 1 µg/kg reduced the incidence of EA and PACU length of stay and improved postoperative pain management.

Trial Registration Number: IRCT 2016122031497N1.