OPTICOM (Pain Treatment for Children on Mechanical Ventilation)

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
For more information, contact the study team at bethany.kistler@duke.edu.

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.
No matter the treatment group to which your child is assigned, their pain management will continue to be monitored by their doctor, who will use opioids as necessary to treat your child's pain according to their medical judgment.

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