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Combogesic® IV for Acute Pain in Children

This study is testing Combogesic® IV, an intravenous (given through a vein) medicine that combines two pain relievers: ibuprofen and acetaminophen. The main goal is to understand how your child's body processes and clears Combogesic® IV, and to see if it's safe for children and teenagers aged 2 to under 17 years old who are experiencing acute pain (sudden, severe pain). To join, your child must be hospitalized for acute pain and need multiple doses of non-opioid pain medication given through a vein. The study will measure any side effects that happen from the time your child starts receiving Combogesic® IV until 7 days after their last dose. The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 60 participants. It is not specified if it is randomized, blinded, or what phase it is.
What's involved
Your child will receive Combogesic® IV as an intravenous infusion for about 15 minutes, every 6 hours as needed, up to 4 doses per day. This treatment will last for a minimum of 12 hours (2 doses) and a maximum of 5 days (20 doses).
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for treatment-emergent adverse events (side effects) from the start of Combogesic® IV exposure up to 7 days after their last dose.

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NCT07225634

A Study of Combogesic® IV (Intravenous) in Pediatric Patients With Acute Pain

Not Yet Recruiting
PHASE3Ages 2–16InterventionalTreatment
AFT Pharmaceuticals, Ltd.
~60 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The incidence of treatment-emergent adverse events (TEAEs) associated with exposure to Combogesic® IV in pediatric patients
Measured over From start of exposure to Combogesic® IV up to 7 days after last dose

Conditions

Acute Pain

Explore related trials

Acute Pain

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Laura Boddington
[email protected]
+64 9 488 0232 ext 735
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Acute pain indications may include but are not limited to post-operative pain associated with musculoskeletal or soft tissue surgery, fractures or injury, or medical procedures.

What this trial measures

  • The incidence of treatment-emergent adverse events (TEAEs) associated with exposure to Combogesic® IV in pediatric patientsFrom start of exposure to Combogesic® IV up to 7 days after last dose

    TEAEs occurring at any timepoint during the treatment period will be coded to MedDRA System Organ Class Code and Preferred Term and tabulated as frequencies and percentages.