Trial Outcomes & Findings for Postoperative Vomiting in Children - Is Dextrose an Effective Prophylactic Anti-emetic? (NCT NCT01912807)
NCT ID: NCT01912807
Last Updated: 2021-10-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
0 to 2 hr after the procedure (in PACU)
Results posted on
2021-10-29
Participant Flow
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
Randomized
|
144
|
146
|
|
Overall Study
COMPLETED
|
108
|
109
|
|
Overall Study
NOT COMPLETED
|
42
|
41
|
Reasons for withdrawal
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
Did not meet elegibility criteria
|
6
|
4
|
|
Overall Study
Lost to Follow-up
|
36
|
37
|
Baseline Characteristics
Postoperative Vomiting in Children - Is Dextrose an Effective Prophylactic Anti-emetic?
Baseline characteristics by cohort
| Measure |
Dextrose (D5NS) - Intervention Group
n=144 Participants
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
|
Ondansetron - Control Group
n=146 Participants
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
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
144 Participants
n=5 Participants
|
146 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
55 Months
n=5 Participants
|
56 Months
n=7 Participants
|
55 Months
n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
55 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Weight (Kg)
|
19.9 Kilograms
STANDARD_DEVIATION 4.9 • n=5 Participants
|
20.0 Kilograms
STANDARD_DEVIATION 5.6 • n=7 Participants
|
20 Kilograms
STANDARD_DEVIATION 5.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Dextrose (D5NS) - Intervention Group
n=144 Participants
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
|
Ondansetron - Control Group
n=146 Participants
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.
|
|---|---|---|
|
Number of Participants With Postoperative Vomiting Between 0 to 2 Hours
|
11 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 2 to 24 hr after procedureParents 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.
Outcome measures
| Measure |
Dextrose (D5NS) - Intervention Group
n=108 Participants
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
|
Ondansetron - Control Group
n=109 Participants
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.
|
|---|---|---|
|
Number of Participants Receiving Rescue Antiemetic Medications
|
15 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Within 24 hours after the procedureData was recorder for number of patients with delays in discharge from PACU due to POV
Outcome measures
| Measure |
Dextrose (D5NS) - Intervention Group
n=144 Participants
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
|
Ondansetron - Control Group
n=146 Participants
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.
|
|---|---|---|
|
Number of Participants Having Delayed Home Discharge
|
2 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: IntraoperativelyMeasuring 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.
Outcome measures
| Measure |
Dextrose (D5NS) - Intervention Group
n=144 Participants
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
|
Ondansetron - Control Group
n=146 Participants
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.
|
|---|---|---|
|
Blood Glucose Level
|
6.3 mmol/L
Interval 5.3 to 7.1
|
5.5 mmol/L
Interval 4.8 to 6.0
|
Adverse Events
Dextrose (D5NS) - Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Ondansetron - Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place