Objectives: Does clonidine, as adjuvant to bupivacaine for suprazygomatic maxillary nerve blocks, reduce emergence agitation in patients undergoing cleft lip and cleft palate surgery?
Design: Randomized, controlled, and double-blind study.
Setting: Guwahati Comprehensive Cleft Care Center, Guwahati (Assam, India).
Participants: A total of 124 patients; with a median age of 5 years in the clonidine group (CLG) and 7 years in the control group (CG), who underwent cleft lip or cleft palate surgery were included. Exclusion criteria included lack of consent from patients or their guardians, allergy to local anesthetics, coagulation disorders, local infection at the puncture site before performing the block, and language difficulties or cognitive disorders.
Interventions: Patients were randomized into 2 groups to receive bilateral suprazygomatic maxillary nerve blocks with either a bupivacaine/clonidine mixture for the CLG or bupivacaine alone in the CG.
Main outcome measure: The primary end point was the incidence of emergence agitation.
Results: There was a statistically significant difference in the incidence of emergence agitation (30.2% in the CG compared to 15.2% in the CLG; difference of incidences: 15%, 95% CI: 0.1-30.1). The percentage of patients requiring intraoperative Fentanyl was lower in the CLG (10.6% compared to 26.4%; difference of incidences: 15.8%, 95% CI: 1.8-29). No other differences were observed. Further research in a more typically aged children population undergoing cleft surgery is needed.
Conclusions: The use of clonidine as an adjuvant to bupivacaine in maxillary nerve block reduces the incidence of emergence agitation and intraoperative opioid consumption without hemodynamic or sedative side effects in patients undergoing cleft lip and palate surgery.
Keywords: cleft surgery; clonidine; double-blinded method; emergence agitation; maxillary nerve block.