Ondansetron + Lidocaine for Injection Site Reaction

Overseen By Vipin Bansal, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Emory University

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

Trial Summary

What is the purpose of this trial?

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.

Research Team

Vipin Bansal, MD

Principal Investigator

Emory University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+