The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, and Pain

The Effects of IV vs Oral Dexamethasone on Postoperative Nausea, Vomiting, Pain, and Drug Cost in Children Undergoing Tonsillectomy: A Randomized Controlled Prospective Non-inferiority Study

The hypothesis being tested in this study is that perioperative oral administration of dexamethasone, when compared to intravenous (IV) administration, offers a similar reduction in postoperative nausea and vomiting (PONV), and reduction in postoperative pain in pediatric patients undergoing tonsillectomy with or without adenoidectomy and/or tympanostomy tube placement. The specific aim of this study is to demonstrate non-inferiority of oral dexamethasone when compared to IV dexamethasone, given that there is currently a severe, sudden, and world-wide shortage of IV dexamethasone given its recent use in treating patients with covid19 disease.

Study Overview

• Status: Completed
• Conditions: Nausea and Vomiting, Postoperative
• Intervention / Treatment: Drug: dexamethasone

Detailed Description

written consent, patients will be randomized at the time of arrival to the preoperative care center on the day of surgery. One hundred twenty-six patients, 3 to 7 years of age undergoing tonsillectomy with or without adenoidectomy and tympanostomy tube placement, will be included in this study. Children who received antiemetics, steroids, anti-histaminic, or psychoactive drugs during the week before surgery will be excluded. Patients will be prospectively randomized to receive oral or IV dexamethasone 0.5 mg/kg (maximum dose 8 mg). Patients in the IV group will receive the dose once an IV is placed in the operating room. They will receive an oral placebo once consent is obtained on arrival to the preoperative center on the day of surgery. Patients in the oral group will receive their dose once consent is obtained on arrival to the preoperative center on the day of surgery. They will receive a placebo once the IV is placed in the operating room. Randomization will be via a computer-generated table of numbers. Study drugs will be marked only with a coded number label. The anesthesiologist, surgeon, patient, and family will be unaware of drug identity. All medication preparation and handling will be done by CHCO Investigational Drug Service.

Patients will be fasted for solid foods for eight hours before surgery; clear liquids will be permitted until two hours before surgery. A standard anesthetic technique will be used. Premedication with oral acetaminophen 12.5-15 mg/kg will be given on arrival to the preoperative center. After obtaining consent study drug or placebo will be given at least 20 minutes before surgery. General anesthesia will be induced with sevoflurane and 60% nitrous oxide in oxygen via mask followed by insertion of an intravenous (IV) cannula. Dexamethasone or placebo will be given immediately following IV placement. Propofol 2 mg/kg and fentanyl 1 µg/kg will be given to facilitate intubation. Anesthesia will be maintained with a mixture of sevoflurane and air (FiO2 < 0.3All children will receive fentanyl 1-3 µg/kg (titrated to pain response in the operating room) and dexmedetomidine 0.5 µg/kg once surgery starts. All children will receive ondansetron 0.1 mg/kg (maximum dose 4 mg).All children will receive 20 mL/kg lactated Ringer's solution during surgery (maximum IV fluid 750 mL given short time of surgical procedure). Routine monitoring including heart rate (ECG), arterial oxygen saturation (SpO2), blood pressure, temperature and end-tidal CO2 will be used throughout surgery. Surgical technique will be standardized, and all patients will have their stomachs suctioned at the completion of surgery.

Each subject will be assessed by nursing staff utilizing standard of care practices in the PACU and patients will stay in the PACU (phase one and two) for 4 hours after surgery. Postoperative nausea and vomiting (PONV) will be defined as vomiting and/or retching without expulsion of gastric content and will be treated with IV phenergan (0.25 mg/kg, maximum 25 mg) followed, if necessary, by IV diphenhydramine (1 mg/kg maximum 50 mg). Pain will be assessed using the numeric pain scale 0-10, Faces, Legs, Arms, Crying, Consolability Scale (FLACC Scale), or Revised Faces Scale.12,13 Pain scores > 5 will be treated with IV fentanyl 0.5 µg/kg that can be repeated every 5 minutes for pain when necessary.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital of Colorado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 7 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 3-7 years of age
• tonsillectomy with or without adenoidectomy and tympanostomy tube placement

Exclusion Criteria:

• Subjects receiving one week before surgery:

  •-antiemetics

• steroids
• anti-histaminic
• psychoactive drugs

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IV Dexmethsone and oral placebo	Drug: dexamethasone; Prevention of post op nausea and vomiting
Active Comparator: Oral dexamethasone and IV placebo	Drug: dexamethasone; Prevention of post op nausea and vomiting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of post op nausea and vomiting	post-op nausea and vomiting as evidenced by vomiting and/or retching without expulsion of gastric content	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain scores and surgical re-exploration for bleeding	Pain as evidenced by a numeric pain scale 0-10, Faces, Legs, Arms, Crying, Consolability Scale (FLACC Scale), or Revised Faces Scale.12,13 . surgical re-exploration as evidenced by the return to O.R. for bleeding	4 hours

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Melissa Brooks Peterson, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2020
• Primary Completion (Actual): May 24, 2023
• Study Completion (Actual): May 24, 2023

Study Registration Dates

• First Submitted: September 18, 2020
• First Submitted That Met QC Criteria: September 23, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: 20-1742

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No