Purpose of this Study
We are doing this study to find out if non-opioid means of pain relief are adequate for children who need mechanical ventilation for the treatment of acute respiratory failure. We want to know if acetaminophen and/or ketorolac can help provide enough relief to lower the need for using opioids to treat pain. Opioid pain medications have side effects (e.g., withdrawal symptoms and delirium) that can potentially be lessened if the study drugs are shown to provide an acceptable benefit.
Who Can Participate?
Eligibility
Children ages 17 years and 6 months and younger who:
- Are being treated for acute respiratory failure
- Have received endotracheal intubation to help maintain their breathing
- Are being treated with opioid pain medications or are a candidate for treatment with opioids
Age Range
0-17
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you and your child choose to join this study, they will get a random assignment (by chance) to 1 of 4 groups:
- Group 1: If your child is in this group, they will get doses of acetaminophen through intravenous (IV) infusion.
- Group 2: If your child is in this group, they will get doses of ketorolac through intravenous (IV) infusion.
- Group 3: If your child is in this group, they will get doses of both acetaminophen and ketorolac through intravenous (IV) infusion.
- Group 4: If your child is in this group, they will get doses of a placebo (normal saline) through intravenous (IV) infusion.
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
Yes
Study Details
Full Title
OPTICOM: Optimizing Pain Treatment In Children On Mechanical Ventilation
Principal Investigator
Christoph
Hornik
Protocol Number
PRO00117564
Phase
IV
Enrollment Status
Pending Open to Enrollment