OPTICOMPain Management in Children on Mechanical Ventilation
Acetaminophen
+ Ketorolac
+ Placebo
Agnosia+4
+ Nervous System Diseases
+ Neurologic Manifestations
Treatment Study
Summary
Study start date: August 20, 2025
Actual date on which the first participant was enrolled.This study focuses on improving pain management for children who need mechanical ventilation due to severe breathing problems. Each year, many children in the United States require this kind of support, but the current methods for controlling their pain often rely on opioids. These drugs can lead to problems like addiction, withdrawal symptoms, and longer hospital stays, and they don't always relieve pain effectively. This study is important because it explores the use of intravenous acetaminophen and ketorolac as alternatives to reduce opioid use and improve pain relief for these young patients. Participants in this study are children aged 2 months to 17 years 6 months who need mechanical ventilation and opioids for pain. They are randomly placed into one of four groups to receive either intravenous acetaminophen with a placebo, intravenous ketorolac with a placebo, both medications together, or both placebos. The medications are given for up to five days, while usual care with opioids and benzodiazepines continues as needed. The study will measure how well the alternative medications control pain and reduce opioid use. This involves complex statistical methods to ensure the findings are accurate and meaningful.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.644 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 Months to 17 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.4 intervention groups are designated in this study
25% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ExperimentalGroup IV
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Children's Hospital of Michigan
Detroit, United StatesOpen Children's Hospital of Michigan in Google MapsDuke Children's Hospital & Health Center
Durham, United StatesRainbow Babies and Children's Hospital
Cleveland, United StatesChildren's Hospital of Philadelphia
Philadelphia, United States