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Completed

NCT Number: NCT01912807

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

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.

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Key information

Age range

3 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prairieview Surgical Centre

Saskatoon, Saskatchewan, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Dextrose 5% in 0,9% Normal Saline

Ondansetron (Control)

Drug

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

Other names: Zofran

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Official study title

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

Acronym: DEXPO

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 31, 2013
Registry last updated
Oct 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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