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

NCT01912807 | Completed Results

• 1 other identifier: 13-163
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Vomiting

Keywords

Postoperative vomiting; Children

Outcome Measures

Primary Outcomes (1)

• 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.

  0 to 2 hr after the procedure (in PACU)

Secondary Outcomes (1)

• Number of Participants Receiving Rescue Antiemetic Medications

  2 to 24 hr after procedure

Other Outcomes (2)

• Number of Participants Having Delayed Home Discharge

  Within 24 hours after the procedure

• Blood Glucose Level

  Intraoperatively

Study Arms (2)

Dextrose (D5NS)

EXPERIMENTAL

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.

Drug: Dextrose (D5NS)

Ondansetron (Control)

ACTIVE COMPARATOR

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.

Drug: Ondansetron (Control)

Interventions

Dextrose (D5NS) DRUG

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

Also known as: Dextrose 5% in 0,9% Normal Saline

Dextrose (D5NS)

Ondansetron (Control) DRUG

Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.

Also known as: Zofran

Ondansetron (Control)

Eligibility Criteria

• Age: 3 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Saskatchewan: lead

Study Sites (1)

Prairieview Surgical Centre

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 32696227 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Glucose; Ondansetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

No true placebo arm (unethical to withhold PONV prophylaxis) Inability to record or analyze the incidence of post-operative nausea This study was underpowered - size estimation Lack of a standardized anesthetic protocol minimized by randomization

Results Point of Contact

• Title: Andrea Vasquez Camargo
• Organization: University of Saskatchewan

a.vasquez@usask.ca

306 7660444

Study Officials

• Andrea Vasquez, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

• Jonathan Gamble, MD

  University of Saskatchewan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor - University of Saskatchewan, Department of Academic Family Medicine

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 31, 2013
• Study Start: December 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 29, 2021
• Results First Posted: October 29, 2021

Record last verified: 2021-09

Locations

CA (1)