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NCT05378113 · ClinicalTrials.gov registry record · Phase 2
Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled Trial
A Phase 2 study of Injection Site Irritation, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05378113: Recruiting Phase 2 study of Injection Site Irritation, sponsored by Emory University.
NCT05378113 is a Phase 2 study of Injection Site Irritation that is actively recruiting participants, run by Emory University. The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05378113, a Phase 2 study of Injection Site Irritation, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
VRS will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no verbal indication of pain, 1 refers to purposeless moaning, 2 refers to explicit protest and 3 refers to screaming/crying of pain. Higher scores indicate a higher level of perceived pain/distress.
Conditions Studied
Interventions
- DRUG Ondansetron
- DRUG Lidocaine
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-05-18 |
| Est. Completion | 2025-12 |
| Phase | Phase 2 |
What NCT05378113 shows while recruiting
NCT05378113 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 1 condition, with Injection Site Irritation appearing as the primary indexed condition, and to 2 interventions - of which Ondansetron is the first listed.
NCT05378113 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05378113 about?
NCT05378113 is a clinical study titled "Ondansetron As a Strategy for Reducing Propofol Injection Pain in Pediatrics: a Randomized Controlled 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 I...
What is the current status of trial NCT05378113?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2023-05-18. Estimated completion is 2025-12.
What conditions does trial NCT05378113 study?
This clinical trial studies the following conditions: Injection Site Irritation.
What interventions are being tested in trial NCT05378113?
The interventions under investigation include: Ondansetron (DRUG), Lidocaine (DRUG).
Who is sponsoring clinical trial NCT05378113?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05378113 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05378113's enrollment target sits among peer trials
120 569th of 2000 higher than 1,384 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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