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

NCT05378113 Phase 2 TERMINATED Results posted

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.

Details

Lead sponsor	Emory University
Phase	Phase 2
Status	TERMINATED
Enrolment	6
Start date	2023-05-18
Completion	2023-08-03

Conditions

• Injection Site Irritation

Interventions

• Ondansetron
• Lidocaine

Primary outcomes

• Verbal Rating Scale (VRS) — Baseline, during propofol injection (30 seconds)
  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.
• Motor Score Scale — Baseline, during propofol injection (30 seconds)
  Motor score scale will be measured in the lidocaine and ondansetron groups. Possible score ranges from 0 to 3, where 0 refers to no movement, 1 refers to slight hand withdrawal, 2 refers to marked withdrawal, rubbing, trying to tear off the line and 3 refers to general restlessness. Higher scores indicate a more severe motor withdrawal response and higher perceived pain or distress.

Countries

United States