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

STUDY00001599

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.

2023-05-18

2024-12-01

2024-12-01

Recruiting

Early phase I

120

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

2024-01-11