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Local Anesthetic

Ondansetron + Lidocaine for Injection Site Reaction

Phase 2

Recruiting

Led By Vipin Bansal, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients 2 years old through 17 years of age

Patients with an American Society of Anesthesiologists (ASA) physical status category score of 1, 2 or 3

Must not have

Patient weighing >40kg

Pain on injection of pre-operative normal saline flush

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, during propofol injection (30 seconds)

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare whether Zofran or lidocaine reduces pain better when injected before propofol in pediatric patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects may include discomfort at the injection site or allergic reactions. Since Ondansetron and Lidocaine are commonly used drugs, significant side effects are rare but will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 2 and 17 years old.

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

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I have a catheter or IV line placed in my arm below the elbow.

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I do not have a chronic pain condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I weigh more than 40kg.

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I feel pain when given a saline shot before surgery.

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I was given an opioid before anesthesia was started.

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I have a long-term pain condition.

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I have been diagnosed with long QT syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, during propofol injection (30 seconds)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, during propofol injection (30 seconds)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, during propofol injection (30 seconds) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Motor score scale from baseline

Change in verbal rating scale (VRS) form baseline

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915

Deep Vein Thrombosis

Cerebrospinal fluid leak

Fever

100%

80%

60%

40%

20%

Study treatment Arm

Ondansetron

Aprepitant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Ondansetron premedication GroupExperimental Treatment1 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 GroupActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ondansetron

2011

Completed Phase 4

~4010

0 / 9Eligibility criteria met