search
Back to results

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

Primary Purpose

Postoperative Vomiting

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Dextrose (D5NS)
Ondansetron (Control)
Sponsored by
University of Saskatchewan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Vomiting focused on measuring Postoperative vomiting, Children

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Prairieview Surgical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dextrose (D5NS)

Ondansetron (Control)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With Postoperative Vomiting Between 0 to 2 Hours
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.

Secondary Outcome Measures

Number of Participants Receiving Rescue Antiemetic Medications
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.

Full Information

First Posted
July 18, 2013
Last Updated
September 28, 2021
Sponsor
University of Saskatchewan
search

1. Study Identification

Unique Protocol Identification Number
NCT01912807
Brief Title
Postoperative Vomiting in Children - Is Dextrose an Effective Prophylactic Anti-emetic?
Acronym
DEXPO
Official Title
Intravenous Dextrose Versus Ondansetron for Prevention of Postoperative Vomiting in Children: a Randomized Non-inferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Saskatchewan

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Vomiting
Keywords
Postoperative vomiting, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dextrose (D5NS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Ondansetron (Control)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dextrose (D5NS)
Other Intervention Name(s)
Dextrose 5% in 0,9% Normal Saline
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Ondansetron (Control)
Other Intervention Name(s)
Zofran
Intervention Description
Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.
Primary Outcome Measure Information:
Title
Number of Participants With Postoperative Vomiting Between 0 to 2 Hours
Description
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.
Time Frame
0 to 2 hr after the procedure (in PACU)
Secondary Outcome Measure Information:
Title
Number of Participants Receiving Rescue Antiemetic Medications
Description
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.
Time Frame
2 to 24 hr after procedure
Other Pre-specified Outcome Measures:
Title
Number of Participants Having Delayed Home Discharge
Description
Data was recorder for number of patients with delays in discharge from PACU due to POV
Time Frame
Within 24 hours after the procedure
Title
Blood Glucose Level
Description
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.
Time Frame
Intraoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Vasquez, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jonathan Gamble, MD
Organizational Affiliation
University of Saskatchewan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prairieview Surgical Centre
City
Saskatoon
State/Province
Saskatchewan
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
32696227
Citation
Vasquez-Camargo A, Gamble J, Fedoruk KA, Lim HJJ, Mondal PK, Martinez J, Miller GG. Intravenous dextrose versus ondansetron for prevention of postoperative vomiting in children: a randomized non-inferiority trial. Can J Anaesth. 2020 Oct;67(10):1333-1340. doi: 10.1007/s12630-020-01757-7. Epub 2020 Jul 21.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs