Postoperative VomitingDEXPONCT01912807
Postoperative Vomiting in Children - Is Dextrose an Effective Prophylactic Anti-emetic?
A study testing Dextrose (D5NS) in people with Postoperative Vomiting, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 9 years
- Conditions the study is for
- Postoperative Vomiting
- What is being tested?
- Dextrose (D5NS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Dextrose Versus Ondansetron for Prevention of Postoperative Vomiting in Children: a Randomized Non-inferiority Trial
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.
Read the 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.
- Conditions
- Postoperative Vomiting
- Being tested
- Dextrose (D5NS), Ondansetron (Control)
- Keywords
- Postoperative vomiting, Children
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose (D5NS)Drug
Also called Dextrose 5% in 0,9% Normal Saline
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
Ondansetron (Control)Drug
Also called Zofran
Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dextrose (D5NS) |
| 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. Receives: Drug: Ondansetron (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0 to 2 hr after the procedure (in PACU)
Secondary outcomes (1)
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.
Measured: 2 to 24 hr after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative VomitingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Vasquez, University of Saskatchewan
- Investigators
- Andrea Vasquez, MD, Principal investigator, University of SaskatchewanJonathan Gamble, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912807
- Sponsor's protocol ID
- 13-163
- Acronym
- DEXPO
- Status last verified
- Sep 2021
- First submitted
- 18 Jul 2013
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 32696227
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dextrose Versus Ondansetron for Prevention of Postoperative Vomiting in Children: a Randomized Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT01912807
- Acronym / sponsor ID
- DEXPO / 13-163
- Conditions
- Postoperative Vomiting
- Keywords
- Postoperative vomiting, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Posted 29 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose (D5NS) | Experimental | Drug: 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. |
| Ondansetron (Control) | Active comparator | Drug: 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. |
Who may qualify
- Ages
- 3 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose (D5NS)Also: Dextrose 5% in 0,9% Normal SalineSolution 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 | Drug | Dextrose (D5NS) |
| Ondansetron (Control)Also: ZofranOndansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight. | Drug | Ondansetron (Control) |
Primary outcome
Number of Participants With Postoperative Vomiting Between 0 to 2 Hours
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.
1 secondary outcome
Number of Participants Receiving Rescue Antiemetic Medications
Time frame: 2 to 24 hr after procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32696227Vasquez-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.
Related trials for Postoperative Vomiting
Not yet recruitingObservational study
Preoperative Gastric Volume and PONV in Pediatric Appendectomy Cases
Postoperative Nausea and Vomiting
Not yet recruiting
Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Vasquez, MD principal investigator
University of Saskatchewan
Jonathan Gamble, MD principal investigator
University of Saskatchewan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose (D5NS) in people with Postoperative Vomiting, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Postoperative Vomiting Between 0 to 2 Hours (time frame: 0 to 2 hr after the procedure (in PACU)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01912807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2021.