Trial record 4 of 159 for:    Open Studies | "Vomiting"

Postoperative Vomiting in Children - Is Dextrose Effective for Prevention? (DEXPO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Saskatchewan
Sponsor:
Information provided by (Responsible Party):
Grant Miller, University of Saskatchewan
ClinicalTrials.gov Identifier:
NCT01912807
First received: July 18, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

The aim of this study is to test the efficacy of intravenous dextrose in preventing POV in pediatric population undergoing dental day surgery at the Prairieview Surgery Centre in Saskatoon.

In previous studies IV dextrose has demonstrated to reduce postoperative nausea and vomiting. It is a commonly used and safe intervention that could potentially reduce the amount of rescue antiemetic medications, improve recovery in same-day surgery pediatric patients as well as the impact on patient and parents satisfaction after the procedure.


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 Effective for Prevention? A 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)will be recorded at immediate postoperative period, at 2 hours after the procedure and prior to discharge.

    Parents will be informed during the consent process that postoperative 24 hour follow up will 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)will be recorded at immediate postoperative period, at 2 hours after the procedure and prior to discharge.

    Parents will be informed during the consent process that postoperative 24 hour follow up will be done over the phone by 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 will also be recorder for Type and number of rescue pain medicines in the PACU Unplanned hospital admission due to Post Operative Vomit (POV) Delays in discharge from PACU due to POV 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, will not cause hyperglycemia in the participants. This measurement will be done while the patients still under general anesthetic during the procedure.


Estimated Enrollment: 300
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dextrose (D5NS)
The participants will receive Dexamethasone (dose 0,015 mg/Kg) as standard antiemetic prophylaxis and Dextrose 5% in Normal Saline (D5NS) will be 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)
Other Name: Dextrose 5% in 0,9% Normal Saline
Active Comparator: Ondansetron (Control)
The control group will receive Dexamethasone (dose 0,015 mg/Kg)as standard antiemetic prophylaxis. Ondansetron (dose 0,05 mg/Kg) will be used as a second prophylactic antiemetic.
Drug: Ondansetron (Control)
Other Name: Zofran

Detailed Description:

Healthy pediatric patients (ages 3 - 9) with Physical Status Classification System American Society of Anesthesiology (ASA) I and II scheduled for ambulatory dental surgery will be enrolled to determine the rates of postoperative vomit (POV) after intraoperative administration of IV dextrose in Normal Saline (D5NS).

The assignment of the participants will be done randomly. The intervention group will receive D5NS at maintenance intravenous rate. The control group (150 patients) will receive Normal Saline (NS) not containing dextrose at a similarly calculated intravenous rate. Both groups (intervention and control) will receive Dexamethasone as standard antiemetic prophylaxis. As a second antiemetic, the control group will receive Ondansetron and the intervention group will receive D5NS at an intravenous rate calculated based on their weight and determined for the purpose of the study.

Patients will then undergo a general anesthetic maintained with a volatile anesthetic and including endotracheal intubation, crystalloids (RL or NS) for IV fluid replacement therapy as well as narcotics and other medications at the discretion of the anesthetic provider based on the standard of care from the American Society of Anesthesiologists. While the patient is asleep, under general anesthetic, the blood sugar level will be measure using a chemstrip and a glucometer. There is no need to send any sample to the laboratory for results.

The researchers will be in the Post Anesthesia Care Unit (PACU) in order to document the measured outcomes at different times; immediate postoperative period and 2 hours postoperatively / discharge time; as this is the length of stay in the PACU before discharge.

The researchers will also follow up with the participants/parents 24 hours after discharge via telephone and record the same outcome variables, including any medical attention sought after discharge due to POV.

  Eligibility

Ages Eligible for Study:   3 Years to 9 Years
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 Recruiting
Saskatoon, Saskatchewan, Canada
Contact: Andrea Vasquez, MD       anv465@mail.usask.ca   
Contact: Kelly Fedoruk, MD       kef706@mail.usask.ca   
Sub-Investigator: Andrea Vasquez, MD         
Sub-Investigator: Kelly Fedoruk, MD         
Principal Investigator: Grant Miller, MD         
Sub-Investigator: Jonathan Gamble, MD         
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

No publications provided

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: January 15, 2014
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
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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 September 15, 2014