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

Postoperative Vomiting Clinical Trial

— DEXPO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912807
• Other study ID #: 13-163
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: September 2014

Study information

• Verified date: September 2021
• Source: University of Saskatchewan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Postoperative Nausea and Vomiting
• Postoperative Vomiting
• Vomiting

Intervention

Drug:
• Dextrose (D5NS)
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
• Ondansetron (Control)
Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.

Locations

Country	Name	City	State
Canada	Prairieview Surgical Centre	Saskatoon	Saskatchewan

Sponsors (1)

Lead Sponsor	Collaborator
University of Saskatchewan

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants Having Delayed Home Discharge	Data was recorder for number of patients with delays in discharge from PACU due to POV	Within 24 hours after the procedure
Other	Blood Glucose Level	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
Primary	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	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.	2 to 24 hr after procedure