Ondansetron + Lidocaine for Injection Site Reaction

Overseen By Vipin Bansal, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

Must not be taking: Opioids

Disqualifiers: Chronic pain, Long QT syndrome, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Single surgery duration

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Zofran, a medication often used to prevent nausea, can reduce the pain children experience when receiving propofol, a common anesthesia medicine, through an IV. It compares Zofran with lidocaine, the usual local anesthetic used to ease this pain. The trial includes children aged 2 to 17 undergoing surgery at Children's Healthcare of Atlanta who already have an IV in their arm. Children with known chronic pain conditions or those who have recently taken opioids are excluded. The goal is to find a better way to keep children comfortable during anesthesia. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to improve pediatric anesthesia care.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have received an opioid within 30 minutes before anesthesia, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ondansetron, also known as Zofran, is generally safe and well-tolerated. Some people might experience pain, redness, or burning at the injection site. Less common side effects include hiccups, low blood pressure, and a rare condition affecting eye movements. Despite these potential issues, ondansetron is widely used to prevent nausea and vomiting and is generally considered safe.

Lidocaine, often used to numb areas and reduce pain, also has a well-established safety record. It is commonly used in many procedures and is usually well-tolerated. The most common side effect is a temporary numbing or tingling sensation around the injection site, with serious side effects being rare.

Both treatments have been widely used, and their safety is well-documented. This trial aims to determine if ondansetron can aid in pain control compared to the already common use of lidocaine. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about testing ondansetron and lidocaine for reducing injection site reactions because these treatments might offer new benefits compared to the usual options. Ondansetron, typically used to prevent nausea, is being explored for its potential to reduce discomfort when combined with propofol, due to its different mechanism of affecting nerve signals at the injection site. Lidocaine, a local anesthetic, is already known to ease pain by numbing the area, but its use in this specific protocol with propofol could enhance patient comfort more effectively than current practices. By comparing these two approaches, researchers hope to find a more efficient way to minimize pain and irritation during medical procedures.

What evidence suggests that this trial's treatments could be effective for reducing injection site pain?

This trial will compare the effectiveness of ondansetron and lidocaine in reducing pain from propofol injections. Research has shown that ondansetron, administered to participants in the ondansetron premedication group, can effectively reduce pain from propofol injections. It works similarly to lidocaine, which participants in the lidocaine premedication group will receive and is already commonly used for this purpose. Some studies suggest that while ondansetron helps, lidocaine might be even more effective at easing pain. Both treatments aim to make IV injections smoother and less painful for patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Vipin Bansal, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for children aged 2-17 undergoing surgery at Children's Healthcare of Atlanta Egleston, with a working IV in their arm and an ASA score of 1-3. They must not have chronic pain syndromes, long QT syndrome, weigh over 40kg, allergies to the study meds, or have taken opioids within 30 minutes before anesthesia.

Inclusion Criteria

My parent or guardian agrees to participate and can sign the consent form.

I am between 2 and 17 years old.

My health is good to moderately impaired according to the ASA score.

Exclusion Criteria

I weigh more than 40kg.

I feel pain when given a saline shot before surgery.

I am scheduled for an endoscopy procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either ondansetron or lidocaine prior to propofol injection during surgery

Single surgery duration

1 visit (in-person)

Follow-up

Participants are monitored for pain and vital signs during and immediately after propofol injection

During surgery

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine
• Ondansetron

Trial Overview The trial is testing if Zofran (Ondansetron) given before propofol can reduce injection pain compared to Lidocaine. It's a randomized study where kids are put into one of these two treatment groups by chance.

How Is the Trial Designed?

Group I: Ondansetron premedication Group Experimental Treatment 1 Intervention

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.

Group II: Lidocaine premedication Group Active Control 1 Intervention

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 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Lidocaine for:

• Local anesthesia for minor surgical procedures
• Surface anesthesia for minor procedures
• Spinal anesthesia
• Epidural anesthesia

Approved in European Union as Lidocaine for:

• Local anesthesia
• Regional anesthesia
• Surface anesthesia

Approved in Canada as Lidocaine for:

• Local anesthesia
• Regional anesthesia

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5328425/

Efficacy of ondansetron for the prevention of propofol ... Conclusion. Ondansetron can effectively prevent propofol injection pain, and the effect is similar to that of magnesium sulfate and lidocaine.

2. journals.lww.com journals.lww.com/md-journal/fulltext/2023/09220/effect_of_ondansetron_compared_to_lidocaine_and.10.aspx

Effect of ondansetron compared to lidocaine and placebo ... Ondansetron is effective in reducing post-operative propofol-induced pain. However, lidocaine is more effective than it.

3. bmcanesthesiol.biomedcentral.com bmcanesthesiol.biomedcentral.com/articles/10.1186/s12871-022-01650-4

A comparison of ondansetron and lidocaine in reducing ... In this study, we compared the efficacy of 8 mg. ondansetron to 40 mg. lidocaine and a placebo for the reduction of propofol injection pain as the primary ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10519458/

Effect of ondansetron compared to lidocaine and placebo for ... Conclusion: Ondansetron is effective in reducing post-operative propofol-induced pain. However, lidocaine is more effective than it. Keywords: ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0753332221005072

The intraperitoneal ondansetron for postoperative pain ... In line with our findings, the results of a meta-analysis of ten RCTs, totaling 782 patients, showed that ondansetron effectively prevented local pain of ...

6. mayoclinic.org mayoclinic.org/drugs-supplements/ondansetron-injection-route/description/drg-20065221

Ondansetron (injection route) - Side effects & uses Chest pain, discomfort, or tightness; pain, redness, or burning at the injection site; skin rash, hives, redness, or itching; trouble breathing ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2014/020007s046lbl.pdf

ZOFRAN Injection - accessdata.fda.gov 189. Local Reactions: Pain, redness, and burning at site of injection. 190. Lower Respiratory: Hiccups. 191. Neurological: Oculogyric crisis, appearing alone ...

8. novartis.com novartis.com/us-en/sites/novartis_us/files/zofran_inj_0.pdf

ZOFRAN® Injection Pain, redness, and burning at site of injection. Lower Respiratory. Hiccups. Neurological. Oculogyric crisis, appearing alone, as well as with other dystonic ...

9. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499839/

Ondansetron - StatPearls - NCBI Bookshelf - NIH Ondansetron is a widely prescribed medication for nausea and vomiting from various causes. The drug is relatively safe, but prescribers, including nurse ...

10. dhpp.hpfb-dgpsa.ca dhpp.hpfb-dgpsa.ca/dhpp/resource/87549/consumer-information

Consumer Information for: ONDANSETRON INJECTION, USP You may also experience pain, redness and burning at the injection site. Although uncommon, low blood pressure and hiccups have also been reported. If your ...