A Study of Combogesic IV (Intravenous) in Pediatric Patients With Acute Pain
Status:
NOT_YET_RECRUITING
Trial end date:
2026-10-01
Target enrollment:
Participant gender:
Summary
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.