Optimizing Pain Treatment in Children On Mechanical Ventilation

Study Summary

In this clinical trial, investigators want to learn more about using non-opioid pain medications for children with acute respiratory failure. Right now, doctors give these children opioids to help with pain while they are on the ventilator, but investigators don't know if this is the best way to manage their pain. Even with strong doses of opioids, more than 90% of these children still feel pain. Other pain medicines, like acetaminophen (also called Tylenol) and ketorolac (also called Toradol), are available but aren't commonly used because we don't know if they help. The goal of this clinical trial is to test if acetaminophen and/or ketorolac can improve pain control and reduce the need for stronger pain medications (opioids) in these children. To learn more about this, participants will be randomly placed in one of four study treatment groups. This means that a computer will decide by chance which group each participant is in, not the doctors running the study. Each group will receive a combination of intravenous acetaminophen, ketorolac or a harmless substance called a placebo. In this clinical trial, placebos help investigators see if the actual medications (acetaminophen and ketorolac) work better than something that doesn't contain medicine. By comparing participants who get the real medicine with those who get the placebo, investigators can find out if these medications effectively decrease pain.

Primary Outcome

Pain will be assessed using the Face, Legs, Activity, Cry, Consolability (FLACC) score. Coma will be defined using standardized sedation scales. The number of time periods where the participant is both pain-free (FLACC \<4) and coma-free will be recorded.

Conditions Studied

Interventions

• DRUG Placebo
• DRUG Acetaminophen
• DRUG Ketorolac

Study Locations (15)