Optimizing Pain Treatment in Children On Mechanical Ventilation

Conditions

• Analgesics, Opioid
• Mechanical Ventilation
• Pediatric Acute Respiratory Failure
• Sedation and Analgesia

Eligibility Criteria

Sex

ALL

Age

2 Months - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Acetaminophen — DRUG
  Intravenous (IV) dose, 15 mg/kg\* (maximum 1g) every 6 h for 5 days. \*Note: The dosing of acetaminophen for intravenous infusion will follow the current Acetaminophen for injection labeling based on the participant's age and weight.
• Ketorolac — DRUG
  IV dose; 0.5mg/kg (maximum 15 mg) every 6 h for 5 days. \*Note: Ketorolac for intravenous bolus administration is currently labeled for multiple-dose treatment in adults. For patients under 65 years of age, the recommended dose is 30 mg every 6 hours, with a maximum daily dose of 120 mg. For patients 65 years or older, renally impaired patients, and those weighting less than 50 kg, the recommended dose is 15 mg every 6 hours, with a maximum daily dose of 60 mg. In this study, we will be limiting ketorolac to ≤15 mg per dose, with a maximum of 60 mg per day.
• Placebo — DRUG
  Placebos will be normal saline solution, i.e., 0.9% NaCl. In order to maintain blinding, the investigational pharmacy will dispense placebo in a volume to match the corresponding study drug.

Study Details

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.

Key Dates

Start date

Dec 29, 2025

Status verified

Feb 2026

Primary completion

Jul 31, 2029

Completion

Aug 31, 2029

Study Design

Enrollment

644 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Arms

• Experimental: Intravenous Acetaminophen (IV-A) + Intravenous Placebo
  Participants receive intravenous acetaminophen and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
• Experimental: Intravenous Ketorolac (IV-K) + Intravenous Placebo
  Participants receive intravenous ketorolac and intravenous placebo every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
• Experimental: Intravenous Acetaminophen (IV-A) + Intravenous Ketorolac (IV-K)
  Participants receive intravenous acetaminophen and intravenous ketorolac every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.
• Placebo Comparator: Intravenous Placebo + Intravenous Placebo
  Participants receive intravenous placebo infusions every 6 hours, alongside open-label opioids per standard of care, for up to 5 days.

Primary Outcome Measure

Acute Pain Episodes [ Time Frame: First 5 days of mechanical ventilation or until extubation, whichever comes first ]

Central Contacts

• Chani Traube, MD
  212-746-3056
  [email protected]
• Kammy Jacobsen
  [email protected]

Locations (15)

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