Prairieview Surgical Centre
Saskatoon, Saskatchewan, Canada
NCT Number: NCT01912807
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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Notify Me3 year–9 year
All sexes
Interventional
Not applicable
Saskatoon, Saskatchewan, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.
Other names: Zofran
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.
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.
Time frame: Within 24 hours after the procedure
Data was recorder for number of patients with delays in discharge from PACU due to POV
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.
University of Saskatchewan
Other
Intravenous Dextrose Versus Ondansetron for Prevention of Postoperative Vomiting in Children: a Randomized Non-inferiority Trial
Acronym: DEXPO
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