Seeking a Viable Alternative: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Study of Oral Versus IV Dexamethasone in Children Undergoing Tonsillectomy.

Introduction: Tonsillectomy is associated with a high rate of postoperative nausea and vomiting (PONV), ranging between 40% and 73%, and dexamethasone has been found to have a prophylactic effect on PONV in children undergoing tonsillectomy. In 2020, there was a sudden, severe shortage of intravenous dexamethasone given its role in treating patients with COVID-19. The primary aim of this study was to investigate the viability of an alternative: non-inferiority of oral versus intravenous dexamethasone for preventing PONV. Secondary objectives included pain and surgical complication outcomes.

Methods: One hundred twenty-six patients aged 3 to 7 years old undergoing tonsillectomy were prospectively randomized to receive 0.5 mg/kg oral or intravenous dexamethasone (maximum dose 8 mg). PONV data were recorded from the post-anesthesia care unit and post-op day 3 to 5 nursing phone calls. Pain was assessed using the numeric pain scale 0 to 10 or the Faces, Legs, Arms, Crying, Consolability (FLACC) Scale.

Results: Seventy-two (57.1%) males and 54 (42.9%) females with a mean age of 5.36 years were included in the analysis. Sixty-three (50.0%) patients received oral dexamethasone, and 63 patients received intravenous dexamethasone. Three patients were noted to have nausea in the post-anesthesia care unit, all of whom received oral dexamethasone (2.4%), an absolute risk difference of 4.8% (95% CI 1.6% to 9.5%). Four patients had vomiting in the post-anesthesia care unit, all of whom received oral dexamethasone (3.2%), an absolute risk difference of 6.3% (95% CI 1.6% to 11.1%). Fifteen patients reported nausea and vomiting after discharge; 6/15 (40%) received oral dexamethasone and 9/15 (60%) received intravenous dexamethasone (absolute risk difference -5.4% (95% CI -15.6% to 4.9%)).

Discussion: Substituting oral dexamethasone in place of intravenous dexamethasone resulted in a non-inferior rate of PONV for pediatric patients undergoing tonsillectomy. Oral dexamethasone is a reasonable substitute for intravenous dexamethasone, particularly during an immediate, unexpected medication shortage.