Postoperative Vomiting in Children - Is Dextrose an Effective Prophylactic Anti-emetic? (DEXPO)

September 28, 2021 updated by: Andrea Vasquez, University of Saskatchewan

Intravenous Dextrose Versus Ondansetron for Prevention of Postoperative Vomiting in Children: a Randomized Non-inferiority Trial

The aim of this study was to investigate the efficacy of intraoperative intravenous dextrose in preventing POV in pediatric population undergoing dental day surgery.

Post-operative vomiting (POV) in children is a frequent complication. Studies using intravenous (IV) fluids containing dextrose in the perioperative period have shown improvement of POV in adults. Similar studies have not been done in children.

Knowing that Intravenous (IV) fluids containing dextrose are safe and commonly used in the paediatric population, this intervention could potentially reduce the amount of rescue antiemetic medications and improve recovery in same-day surgery paediatric patients.

Study Overview

Status

Completed

Detailed Description

A non-inferiority randomized control trial of healthy children (3-9 years old) undergoing ambulatory dental surgery was conducted to investigate the efficacy of intraoperative IV fluids containing dextrose for antiemetic prophylaxis.

The control group (146 participants) received dexamethasone (0.15 mg/kg IV) and ondansetron (0.05 mg/kg IV); the intervention group (144) received dexamethasone (0.15 mg/kg IV) and intravenous 5% dextrose in 0.9% normal saline (D5NS) as per a weight based maintenance rate.

Patients underwent a general anesthetic maintained with a volatile anesthetic. There was not a standardized protocol for anesthetic induction and maintenance, and all types and doses of anesthetic medications were chosen and administered at the discretion of the anesthesiologist. Intraoperative administration of any other antiemetic medications constituted protocol violation and excluded the patient from analysis. There were no modifications to the planned dental procedure.

Once IV access was established and the patient was intubated, the maintenance study solution was connected and infused throughout the operative period. Additional fluid (Ringer's Lactate) was available to the anesthesiologists to administer as per their preference.

The study drug was administered to the patient by the anesthesiologist at the end of the procedure, when the throat packing was removed and the IV maintenance study solution was stopped. Before emergence from anesthesia, the researcher measured and recorded the patient's blood sugar via a chemstrip (AccuCheck aviva ®). Ringer's Lactate IV fluid, not part of study protocol, was continued in recovery based on the anesthesiologist's preference.

All patients were transferred to the post-anesthetic care unit (PACU) at the end of the procedure. Discharge from the PACU was based on the Post Anesthetic Discharge Scoring System (PADSS) and institutional guidelines. Nursing staff and researchers recorded the presence and incidence of POV in the PACU. Analgesics and antiemetic agents were prescribed by the anesthesiologist during the recovery period and given according to nursing assessment based on institutional guidelines.

Researchers phoned participants 24 hours after discharge to inquire about incidence of emesis and any need to seek medical attention after being discharged from the institution.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Prairieview Surgical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 3 to 9 Years of age
  • Male and Female
  • ASA I and II
  • Paediatric patients undergoing same-day dental procedures at the Prairieview Surgical Centre.

Exclusion Criteria:

  • Age <3 or >9
  • Underlying pro-emetic disease
  • Positive history of POV in the patient, parent or sibling
  • Currently on antiemetic medications
  • Parent refusal to sign consent
  • History of juvenile diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dextrose (D5NS)
The participants received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis and Dextrose 5% in 0.9 % Normal Saline (D5NS) was used as a second antiemetic, at an intravenous rate calculated based on their weight and determined for the purpose of the study.
Solution Dextrose 5% in Normal Saline (D5NS) was used as a second antiemetic, at an intravenous maintenace rate (4 cc per Kg for first 10 Kg, 2 cc per Kg for next 10 Kg and 1 cc per Kg for the next Kg of weight) calculated based on the patient's weight
Other Names:
  • Dextrose 5% in 0,9% Normal Saline
Active Comparator: Ondansetron (Control)
The control group received Dexamethasone (dose 0,15 mg/Kg) as standard antiemetic prophylaxis. Ondansetron (dose 0,05 mg/Kg) was used as a second prophylactic antiemetic.
Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.
Other Names:
  • Zofran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Postoperative Vomiting Between 0 to 2 Hours
Time Frame: 0 to 2 hr after the procedure (in PACU)

In the Post Anesthetic Care Unit (PACU) the proper data (intraoperative and recovery period) was recorded at immediate postoperative period, at 2 hours after the procedure and prior to discharge.

Parents were informed during the consent process that postoperative 24 hour follow up was going to be done over the phone by researcher.

0 to 2 hr after the procedure (in PACU)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Receiving Rescue Antiemetic Medications
Time Frame: 2 to 24 hr after procedure

Parents were informed during the consent process that postoperative 24 hour follow up was going to be done over the phone by the researcher.

The number of participants (parents / caregivers) who answered the call was recorded, and from those the number of patients who presented the secondary outcome.

2 to 24 hr after procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Having Delayed Home Discharge
Time Frame: Within 24 hours after the procedure
Data was recorder for number of patients with delays in discharge from PACU due to POV
Within 24 hours after the procedure
Blood Glucose Level
Time Frame: Intraoperatively
Measuring the blood glucose level is important to ensure that administration of IV Dextrose at the dose to be used in our protocol, did not cause hyperglycemia in the participants. This measurement was done while patients were still under general anesthetic during the procedure.
Intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Andrea Vasquez, MD, University of Saskatchewan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 18, 2013

First Submitted That Met QC Criteria

July 29, 2013

First Posted (Estimate)

July 31, 2013

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

September 28, 2021

Last Verified

September 1, 2021

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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