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

• Sponsor: University of Saskatchewan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01912807
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 33.3

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Postoperative Vomiting	Drug: Dextrose (D5NS); Drug: Ondansetron (Control)	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Intravenous Dextrose Versus Ondansetron for Prevention of Postoperative Vomiting in Children: a Randomized Non-inferiority Trial
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Zofran

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Postoperative Vomiting Between 0 to 2 Hours [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 Outcome Measures

1. Number of Participants Receiving Rescue Antiemetic Medications [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 Outcome Measures

1. Number of Participants Having Delayed Home Discharge [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 9 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Prairieview Surgical Centre	Saskatoon	Saskatchewan	Canada

Sponsors and Collaborators

• University of Saskatchewan

Investigators

• Principal Investigator: Andrea Vasquez, MD, University of Saskatchewan
• Principal Investigator: Jonathan Gamble, MD, University of Saskatchewan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Andrea Vasquez, Clinical Assistant Professor - University of Saskatchewan, Department of Academic Family Medicine, University of Saskatchewan
• ClinicalTrials.gov Identifier: NCT01912807
• Other Study ID Numbers: 13-163
• First Posted: Jul 31, 2013
• Last Update Posted: Oct 29, 2021
• Last Verified: Sep 1, 2021

• Keywords provided by Andrea Vasquez, Clinical Assistant Professor - University of Saskatchewan, Department of Academic Family Medicine, University of Saskatchewan: Postoperative vomiting; Children
• Additional relevant MeSH terms: Vomiting; Postoperative Nausea and Vomiting; Ondansetron

Study Results

Participant Flow

Arm/Group Title	Dextrose (D5NS) - Intervention Group	Ondansetron - Control Group
Arm/Group Description	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	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.
Period Title: Overall Study
STARTED	150	150
Randomized	144	146
COMPLETED	108	109
NOT COMPLETED	42	41

Baseline Characteristics

Arm/Group Title	Dextrose (D5NS) - Intervention Group	Ondansetron - Control Group	Total
Arm/Group Description	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	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.	Total of all reporting groups
Overall Participants	144	146	290
Age (Count of Participants)
<=18 years	144 100%	146 100%	290 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (Months) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [Months]	55	56	55
Sex: Female, Male (Count of Participants)
Female	70 48.6%	74 50.7%	144 49.7%
Male	74 51.4%	72 49.3%	146 50.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	46 31.9%	42 28.8%	88 30.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	38 26.4%	37 25.3%	75 25.9%
More than one race	5 3.5%	11 7.5%	16 5.5%
Unknown or Not Reported	55 38.2%	56 38.4%	111 38.3%
Weight (Kg) (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]	19.9 (4.9)	20.0 (5.6)	20 (5.3)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Postoperative Vomiting Between 0 to 2 Hours
Description	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	0 to 2 hr after the procedure (in PACU)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dextrose (D5NS) - Intervention Group	Ondansetron - Control Group
Arm/Group Description	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	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.
Measure Participants	144	146
Count of Participants [Participants]	11 7.6%	5 3.4%

2. Secondary Outcome

Title	Number of Participants Receiving Rescue Antiemetic Medications
Description	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	2 to 24 hr after procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dextrose (D5NS) - Intervention Group	Ondansetron - Control Group
Arm/Group Description	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	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.
Measure Participants	108	109
Count of Participants [Participants]	15 10.4%	9 6.2%

3. Other Pre-specified Outcome

Title	Number of Participants Having Delayed Home Discharge
Description	Data was recorder for number of patients with delays in discharge from PACU due to POV
Time Frame	Within 24 hours after the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dextrose (D5NS) - Intervention Group	Ondansetron - Control Group
Arm/Group Description	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	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.
Measure Participants	144	146
Count of Participants [Participants]	2 1.4%	0 0%

4. Other Pre-specified Outcome

Title	Blood Glucose Level
Description	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.
Time Frame	Intraoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dextrose (D5NS) - Intervention Group	Ondansetron - Control Group
Arm/Group Description	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	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.
Measure Participants	144	146
Median (Inter-Quartile Range) [mmol/L]	6.3	5.5

Adverse Events

Time Frame	Within 24 hours of administration of intervention (D5NS) vs Ondansetron.
Arm/Group Title	Dextrose (D5NS) - Intervention Group		Ondansetron - Control Group
Arm/Group Description	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		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.
All Cause Mortality
	Dextrose (D5NS) - Intervention Group		Ondansetron - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/144 (0%)		0/146 (0%)
Serious Adverse Events
	Dextrose (D5NS) - Intervention Group		Ondansetron - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/144 (0%)		0/146 (0%)
Other (Not Including Serious) Adverse Events
	Dextrose (D5NS) - Intervention Group		Ondansetron - Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/144 (0%)		0/146 (0%)

Limitations/Caveats

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

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.