Injection Site IrritationPhase 2NCT05378113
Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
A Phase 2 study testing Ondansetron and Lidocaine in people with Injection Site Irritation, run by Emory University at 1 site in United States.
Trial summary
This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. The investigators want to see if in pediatric patients, giving Zofran prior to propofol, reduces the pain that patients often experience when propofol is injected through an IV. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Injection Site Irritation
- What is being tested?
- Ondansetron and Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 May 2023to 3 Aug 2023
- Phase
- Phase 2
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients 2 years old through 17 years of age
- Children undergoing surgery at Children's Healthcare of Atlanta Egleston location
- Patient with existing peripheral vascular access in the arm below the antecubital fossa
- Patients with an American Society of Anesthesiologists (ASA) physical status category score of 1, 2 or 3
- Parent or legal guardian willing to participate, and able to understand and sign the provided informed consent
- No known chronic pain syndrome
Who cannot join
- Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent
- Known chronic pain syndrome
- Patient diagnosed with long QT syndrome
- Patient weighing >40kg
- Documented allergy to study medications
- Pain on injection of pre-operative normal saline flush
- Patient has received an opioid within 30 minutes prior to anesthesia induction
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. The investigators want to see if in pediatric patients, giving Zofran prior to propofol, reduces the pain that patients often experience when propofol is injected through an IV. Subjects will be randomized to 1 of 2 groups: lidocaine (common standard of care), or Zofran. The investigators hope to show a means of improving pain control in their patients undergoing anesthesia.
Read the detailed description
Propofol is a drug commonly used at the beginning of anesthesia (induction). Patients often experience discomfort when propofol is injected through an IV. Ondansetron (Zofran) is a drug that is commonly used to treat nausea after anesthesia. In adult studies, it has been shown that there is significantly less pain when Zofran is given just before propofol is given. The investigators want to see if giving Zofran prior to propofol reduces the pain and discomfort experienced by pediatric patients.
This study is a randomized, single-site clinical trial that will take place at Children's Healthcare of Atlanta at Egleston. Subjects will be randomized to 1 of 2 groups: lidocaine (common standard of care), or Zofran. During induction the treating anesthesiologist will be blinded to the study arm, however they will be unblinded at the end of induction. All subjects will receive Zofran at some point during the surgery - for patients not in the Zofran arm, they will receive it at the end of the case as usual. A blinded observer will score the subject's pain during propofol injection and vital signs will be recorded.
Subjects will be identified by the study team from the surgery schedule. Patients ages 2-17 undergoing surgery with peripheral vascular access (an IV) will be approached. Consent and assent (when appropriate) will be obtained. Subjects will not be compensated. Participation will consist only of the single duration of the surgery.
In this study the investigators hope to show a means of improving pain control in their patients undergoing anesthesia.
- Conditions
- Injection Site Irritation
- Being tested
- Ondansetron, Lidocaine
- Keywords
- Injection site pain, Propofol, Ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran, Ondansetron hydrochloride
Ondansetron (Zofran) is a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist commonly used to treat postoperative nausea and vomiting.
LidocaineDrug
Also called Xylocaine, lidocaine hydrochloride (HCl) Injection
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.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron premedication Group | Experimental | 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. Receives: Drug: Ondansetron |
| Lidocaine premedication Group | Active comparator | 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. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal Rating Scale (VRS)
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.
Measured: Baseline, during propofol injection (30 seconds)
Motor Score Scale
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.
Measured: Baseline, during propofol injection (30 seconds)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start18 May 2023
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Why it stopped: Study was terminated due to enrollment challenges following the relocation of orthopedic procedures to a different hospital.
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.
- Other trials for Injection Site IrritationStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vipin Bansal, Emory University
- Investigators
- Vipin Bansal, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378113
- Sponsor's protocol ID
- STUDY00001599
- Status last verified
- Apr 2026
- First submitted
- 12 May 2022
- Last updated
- 24 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No