Postoperative Vomiting
Conditions
Keywords
Postoperative vomiting, Children
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.
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.
Interventions
DRUGDextrose (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
Ondansetron was used at a prophylactic dose (0,05 mg per Kg) based on patient's weight.
Sponsors
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 9 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 144 |
| 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. | 146 |
| Total | 290 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not meet elegibility criteria | 6 | 4 |
| Overall Study | Lost to Follow-up | 36 | 37 |
Baseline characteristics
| Characteristic | Ondansetron - Control Group | Total | Dextrose (D5NS) - Intervention Group |
|---|---|---|---|
| Age, Categorical <=18 years | 146 Participants | 290 Participants | 144 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 56 Months | 55 Months | 55 Months |
| Race (NIH/OMB) American Indian or Alaska Native | 42 Participants | 88 Participants | 46 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 16 Participants | 5 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 56 Participants | 111 Participants | 55 Participants |
| Race (NIH/OMB) White | 37 Participants | 75 Participants | 38 Participants |
| Sex: Female, Male Female | 74 Participants | 144 Participants | 70 Participants |
| Sex: Female, Male Male | 72 Participants | 146 Participants | 74 Participants |
| Weight (Kg) | 20.0 Kilograms STANDARD_DEVIATION 5.6 | 20 Kilograms STANDARD_DEVIATION 5.3 | 19.9 Kilograms STANDARD_DEVIATION 4.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 144 | 0 / 146 |
| other Total, other adverse events | 0 / 144 | 0 / 146 |
| serious Total, serious adverse events | 0 / 144 | 0 / 146 |
Outcome results
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.
Time frame: 0 to 2 hr after the procedure (in PACU)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dextrose (D5NS) - Intervention Group | Number of Participants With Postoperative Vomiting Between 0 to 2 Hours | 11 Participants |
| Ondansetron - Control Group | Number of Participants With Postoperative Vomiting Between 0 to 2 Hours | 5 Participants |
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.
Time frame: 2 to 24 hr after procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dextrose (D5NS) - Intervention Group | Number of Participants Receiving Rescue Antiemetic Medications | 15 Participants |
| Ondansetron - Control Group | Number of Participants Receiving Rescue Antiemetic Medications | 9 Participants |
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.
Time frame: Intraoperatively
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dextrose (D5NS) - Intervention Group | Blood Glucose Level | 6.3 mmol/L |
| Ondansetron - Control Group | Blood Glucose Level | 5.5 mmol/L |
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
Time frame: Within 24 hours after the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dextrose (D5NS) - Intervention Group | Number of Participants Having Delayed Home Discharge | 2 Participants |
| Ondansetron - Control Group | Number of Participants Having Delayed Home Discharge | 0 Participants |