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

Conditions

• Acute Pain

Eligibility Criteria

Sex

ALL

Age

2 Years - 16 Years

Healthy Volunteers

Not accepted

Interventions

• Combogesic® IV (fixed-dose combination containing acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion) — DRUG
  Acetaminophen 1000 mg and Ibuprofen 300 mg per 100 mL solution for intravenous infusion administered as a 15-minute infusion, every 6 hours, as necessary.

Study Details

Combogesic® IV is an intravenous medicine (given by vein) containing a combination of two pain relief (analgesic) medicines called ibuprofen and acetaminophen. The goal of this clinical trial is to study the way that the body processes and clears the intravenous infusion of Combogesic® IV and that it is safe to be used in children and adolescents between the ages of 2 and \<17 years. What will the study involve for participants? * Combogesic® IV will be administered every 6 hours as necessary with a maximum of 4 doses within a 24-hour period as an intravenous infusion for about 15 minutes. * Participants will receive Combogesic® IV for a minimum of 12 hours (2 doses) up to a maximum of 5 days (20 doses). Dosing will be dependent on body weight. * If pain is not sufficiently controlled by Combogesic® IV, opioids may be used as supplementary pain relief at the discretion of the study doctor. * Have their blood samples collected before dosing and at specific times after dosing. The amount of study drug in the blood will be measured, and safety assessments (including blood and urine samples) will be done. * Rate the study drug at the end of the treatment. It is expected that Combogesic® IV will be well tolerated in children and adolescents and that the pharmacokinetics findings will be similar as compared with adults.

Key Dates

Start date

Feb 28, 2026

Status verified

Nov 2025

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Combogesic® IV
  Combogesic® IV (acetaminophen 10 mg/ml + ibuprofen 3 mg/ml in 100 ml solution for infusion), will be administered by injection into a dedicated indwelling venous cannula, infused over 15 minutes every 6 hours

Primary Outcome Measure

The incidence of treatment-emergent adverse events (TEAEs) associated with exposure to Combogesic® IV in pediatric patients [ Time Frame: From start of exposure to Combogesic® IV up to 7 days after last dose ]

Central Contacts

• Laura Boddington
  +64 9 488 0232 ext 735
  [email protected]

Locations (1)

Find similar trials in Orlando, FL

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