Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Ondansetron as a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial

Conditions
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Injection Site Irritation

Intervention / Treatment
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* Drug: Ondansetron
* Drug: Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Parent or legal guardian unwilling to participate or unable to understand and sign the provided informed consent Patients presenting for endoscopy procedures 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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron premedication Group<br>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. | Drug: Ondansetron<br>* Ondansetron (Zofran) is a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist commonly used to treat postoperative nausea and vomiting.<br>* Other names: Zofran, Ondansetron hydrochloride;|
| Active Comparator: Lidocaine premedication Group<br>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. | Drug: Lidocaine<br>* 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.<br>* Other names: Xylocaine, lidocaine hydrochloride (HCl) Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in verbal rating scale (VRS) form baseline | Difference in total VRS between the lidocaine and ondansetron groups. Possible score ranges from 0 to 3 with higher scores correlating with worse pain. | Baseline, during propofol injection (30 seconds) | 
| Change in Motor score scale from baseline | Change in Motor score between the lidocaine and ondansetron groups. Possible score ranges from 0 to 3 with higher scores correlating with worse pain. | Baseline, during propofol injection (30 seconds) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injection site pain, Propofol, Ondansetron