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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Grant Miller, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01912807
First received: July 18, 2013
Last updated: March 22, 2016
Last verified: March 2016
  Purpose

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.


Condition Intervention
Postoperative Vomiting
Drug: Dextrose (D5NS)
Drug: Ondansetron (Control)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Postoperative Vomiting in Children - Is Dextrose an Effective Prophylactic Anti-emetic? A Non-Inferiority, Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by University of Saskatchewan:

Primary Outcome Measures:
  • Incidence of Postoperative Vomiting [ Time Frame: Within 24 hours after the procedure ] [ Designated as safety issue: No ]

    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:
  • Type and number of rescue antiemetic medications [ Time Frame: within 24 hours after the procedure ] [ Designated as safety issue: No ]

    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 the researcher.



Other Outcome Measures:
  • Rescue pain medications, unplanned hospital admission, delay in discharge. [ Time Frame: within the 24 hours after the procedure ] [ Designated as safety issue: No ]
    Data was recorder for type and number of rescue pain medications in the PACU, unplanned hospital admission due to Post Operative Vomit (POV), delays in discharge from PACU due to POV and return to hospital/MD assessment due to POV

  • Blood glucose level [ Time Frame: Intraoperatively ] [ Designated as safety issue: No ]
    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.


Enrollment: 300
Study Start Date: December 2013
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Other Name: 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.
Drug: Ondansetron (Control)
Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.
Other Name: Zofran

Detailed Description:

A 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.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01912807

Locations
Canada, Saskatchewan
Prairieview Surgical Centre
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
University of Saskatchewan
Investigators
Principal Investigator: Grant Miller, MD University of Saskatchewan
Principal Investigator: Jonathan Gamble, MD University of Saskatchewan
  More Information

Responsible Party: Grant Miller, Medical Doctor, Chair, UGME Curriculum Committee - University of Saskatchewan, Department of Surgery, Division of Pediatric Surgery, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT01912807     History of Changes
Other Study ID Numbers: 13-163 
Study First Received: July 18, 2013
Last Updated: March 22, 2016
Health Authority: Canada: Canadian Institutes of Health Research
Canada: Ethics Review Committee
Canada: Health Canada
Canada: Public Health Agency of Canada

Keywords provided by University of Saskatchewan:
Postoperative vomiting
Children

Additional relevant MeSH terms:
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Nausea
Ondansetron
Antiemetics
Emetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on August 25, 2016