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Seeking a Viable Alternative: A Prospective, Randomized, Controlled, Double-Blind Non-Inferiority Study of Oral
Melissa Brooks Peterson1, Jacob Boyd2, Austin Zhu2
1Independent Scholar.
Insights
Oral dexamethasone is a viable alternative to intravenous dexamethasone for preventing postoperative nausea and vomiting (PONV) in children undergoing tonsillectomy. This study found non-inferiority, supporting its use during medication shortages.
Area of Science:
- Anesthesiology
- Pediatric Surgery
- Pharmacology
Background:
- Postoperative nausea and vomiting (PONV) is common after tonsillectomy in children, affecting 40-73%.
- Dexamethasone effectively prevents PONV in pediatric tonsillectomy patients.
- A 2020 intravenous dexamethasone shortage necessitated exploring alternative administration routes.
Purpose of the Study:
- To determine if oral dexamethasone is non-inferior to intravenous dexamethasone for PONV prevention in pediatric tonsillectomy.
- To evaluate secondary outcomes including pain and surgical complications.
Main Methods:
- 126 pediatric patients (3-7 years) undergoing tonsillectomy were randomized.
- Groups received either 0.5 mg/kg oral or intravenous dexamethasone (max 8 mg).
- PONV data collected from PACU and post-discharge phone calls; pain assessed via standard scales.
Main Results:
- No significant difference in PONV rates between oral and intravenous dexamethasone groups.
- Slightly higher incidence of PONV in the PACU for the oral group (2.4% nausea, 3.2% vomiting).
- Post-discharge nausea and vomiting rates were comparable between groups.
Conclusions:
- Oral dexamethasone is a non-inferior alternative to intravenous dexamethasone for PONV prevention in pediatric tonsillectomy.
- Oral dexamethasone is a practical substitute, especially during intravenous medication shortages.
- This finding supports adapting perioperative protocols based on medication availability.
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.
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It often arises from persistent viral or bacterial infections affecting sinuses and tonsils.
Additional contributing factors include inadequate dental hygiene, mouth breathing, recurring tonsillitis, allergic rhinitis, laryngopharyngeal reflux, and exposure to smoke, chemicals, and other environmental pollutants. Allergic reactions to pollen, mold, and pet dander, chronic cough, excessive voice usage,...