120 Participants Needed

Ondansetron + Lidocaine for Injection Site Reaction

VB
Overseen ByVipin Bansal, MD
Age: < 18
Sex: Any
Trial Phase: Phase 2
Sponsor: Emory University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

VB

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.
See 3 more

Exclusion Criteria

I weigh more than 40kg.
I feel pain when given a saline shot before surgery.
I am scheduled for an endoscopy procedure.
See 5 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Ondansetron premedication GroupExperimental Treatment1 Intervention
Group II: Lidocaine premedication GroupActive Control1 Intervention

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

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Approved in United States as Lidocaine for:
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Approved in European Union as Lidocaine for:
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Approved in Canada as Lidocaine for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials
1,735
Recruited
2,605,000+
Unbiased ResultsWe believe in providing patients with all the options.
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