Trial Outcomes & Findings for Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial (NCT NCT05378113)
NCT ID: NCT05378113
Last Updated: 2026-04-24
Results Overview
Motor score scale will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no movement, 1 refers to slight hand withdrawal, 2 refers to marked withdrawal, rubbing, trying to tear off the line and 3 refers to general restlessness. Higher scores indicate a more severe motor withdrawal response and higher perceived pain or distress.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
Baseline, during propofol injection (30 seconds)
Results posted on
2026-04-24
Participant Flow
Participant milestones
| Measure |
Ondansetron Premedication Group
The ondansetron group will receive ondansetron 0.15mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
Ondansetron: Ondansetron (Zofran) is a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist commonly used to treat postoperative nausea and vomiting.
|
Lidocaine Premedication Group
The lidocaine group will receive lidocaine 2% 1mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
Lidocaine: Lidocaine is a local anesthetic agent used intravenously prior to the propofol injection. Currently the standard of care to help decrease the severity of pain in the injection site, a common side effect of propofol.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
Baseline characteristics by cohort
| Measure |
Ondansetron Premedication Group
n=3 Participants
The ondansetron group will receive ondansetron 0.15mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
Ondansetron: Ondansetron (Zofran) is a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist commonly used to treat postoperative nausea and vomiting.
|
Lidocaine Premedication Group
n=3 Participants
The lidocaine group will receive lidocaine 2% 1mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
Lidocaine: Lidocaine is a local anesthetic agent used intravenously prior to the propofol injection. Currently the standard of care to help decrease the severity of pain in the injection site, a common side effect of propofol.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6 years
STANDARD_DEVIATION 4.32 • n=2 Participants
|
8.67 years
STANDARD_DEVIATION 2.05 • n=1 Participants
|
7.34 years
STANDARD_DEVIATION 3.98 • n=3 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=2 Participants
|
3 Participants
n=1 Participants
|
5 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=2 Participants
|
1 Participants
n=1 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=2 Participants
|
2 Participants
n=1 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=2 Participants
|
3 participants
n=1 Participants
|
6 participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Baseline, during propofol injection (30 seconds)VRS will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no verbal indication of pain, 1 refers to purposeless moaning, 2 refers to explicit protest and 3 refers to screaming/crying of pain. Higher scores indicate a higher level of perceived pain/distress.
Outcome measures
| Measure |
Ondansetron Premedication Group
n=3 Participants
The ondansetron group will receive ondansetron 0.15mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
Ondansetron: Ondansetron (Zofran) is a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist commonly used to treat postoperative nausea and vomiting.
|
Lidocaine Premedication Group
n=3 Participants
The lidocaine group will receive lidocaine 2% 1mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
Lidocaine: Lidocaine is a local anesthetic agent used intravenously prior to the propofol injection. Currently the standard of care to help decrease the severity of pain in the injection site, a common side effect of propofol.
|
|---|---|---|
|
Verbal Rating Scale (VRS)
Baseline VRS score
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Verbal Rating Scale (VRS)
VRS score during propofol injection (30 seconds)
|
0.67 score on a scale
Standard Deviation 0.58
|
0.33 score on a scale
Standard Deviation 0.58
|
PRIMARY outcome
Timeframe: Baseline, during propofol injection (30 seconds)Motor score scale will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no movement, 1 refers to slight hand withdrawal, 2 refers to marked withdrawal, rubbing, trying to tear off the line and 3 refers to general restlessness. Higher scores indicate a more severe motor withdrawal response and higher perceived pain or distress.
Outcome measures
| Measure |
Ondansetron Premedication Group
n=3 Participants
The ondansetron group will receive ondansetron 0.15mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
Ondansetron: Ondansetron (Zofran) is a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist commonly used to treat postoperative nausea and vomiting.
|
Lidocaine Premedication Group
n=3 Participants
The lidocaine group will receive lidocaine 2% 1mg/kg IV push followed immediately by propofol 2mg/kg IV for induction. A 10cc normal saline flush will follow injection of propofol.
Lidocaine: Lidocaine is a local anesthetic agent used intravenously prior to the propofol injection. Currently the standard of care to help decrease the severity of pain in the injection site, a common side effect of propofol.
|
|---|---|---|
|
Motor Score Scale
Motor score scale during propofol injection (30 seconds)
|
0.67 score on a scale
Standard Deviation 1.15
|
1 score on a scale
Standard Deviation 1
|
|
Motor Score Scale
Motor score scale at baseline
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
Adverse Events
Ondansetron Premedication Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lidocaine Premedication 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