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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextrose (D5NS) | Experimental | 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. |
|
| Ondansetron (Control) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Vasquez, MD | University of Saskatchewan | Principal Investigator |
| Jonathan Gamble, MD | University of Saskatchewan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prairieview Surgical Centre | Saskatoon | Saskatchewan | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32696227 | Derived | Vasquez-Camargo A, Gamble J, Fedoruk KA, Lim HJJ, Mondal PK, Martinez J, Miller GG. Intravenous dextrose versus ondansetron for prevention of postoperative vomiting in children: a randomized non-inferiority trial. Can J Anaesth. 2020 Oct;67(10):1333-1340. doi: 10.1007/s12630-020-01757-7. Epub 2020 Jul 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dextrose (D5NS) - Intervention Group | 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. 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 |
| FG001 | Ondansetron - Control Group | 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. Ondansetron (Control): Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dextrose (D5NS) - Intervention Group | 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. 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 0 to 2 hr after the procedure (in PACU) |
|
Within 24 hours of administration of intervention (D5NS) vs Ondansetron.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dextrose (D5NS) - Intervention Group | 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. 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 |
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No true placebo arm (unethical to withhold PONV prophylaxis) Inability to record or analyze the incidence of post-operative nausea This study was underpowered - size estimation Lack of a standardized anesthetic protocol minimized by randomization
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrea Vasquez Camargo | University of Saskatchewan | 306 7660444 | a.vasquez@usask.ca |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D005947 | Glucose |
| D017294 | Ondansetron |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007093 |
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|
| Ondansetron (Control) | Drug | Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight. |
|
|
| Intraoperatively |
| BG001 | Ondansetron - Control Group | 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. Ondansetron (Control): Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Inter-Quartile Range | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight (Kg) | Mean | Standard Deviation | Kilograms |
|
| OG001 | Ondansetron - Control Group | 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. Ondansetron (Control): Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight. |
|
|
| 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. | Posted | Count of Participants | Participants | 2 to 24 hr after procedure |
|
|
|
| Other Pre-specified | Number of Participants Having Delayed Home Discharge | Data was recorder for number of patients with delays in discharge from PACU due to POV | Posted | Count of Participants | Participants | Within 24 hours after the procedure |
|
|
|
| Other Pre-specified | 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. | Posted | Median | Inter-Quartile Range | mmol/L | Intraoperatively |
|
|
|
| 0 |
| 144 |
| 0 |
| 144 |
| 0 |
| 144 |
| EG001 | Ondansetron - Control Group | 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. Ondansetron (Control): Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight. | 0 | 146 | 0 | 146 | 0 | 146 |
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| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |