Population Pharmacokinetic-Pharmacodynamic Study of Intravenous Oxycodone in Children

• Status: Suspended
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Oxycodone has been in clinical use for decades. It is an effective alternative to morphine for moderate to severe acute or chronic pain and has been found to improve quality of life. The drug has been used parenterally or orally as perioperative analgesia or for cancer pain relief. Despite its long clinical experience, prescribing errors and misuse may lead to addiction and accidental overdose. Currently, little is known about the pharmacokinetic properties of intravenous oxycodone among paediatric patients in this region even though the drug has been used in children in other countries such as Finland. Therefore, a pharmacokinetic-pharmacodynamic study of oxycodone among Malaysian pediatric patients is warranted.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Malaya
• Treatments: Oxycodone

Criteria

Inclusion Criteria:

• Aged between 3 to 17 years

• Generally healthy as documented by medical history (ASA 1-II)

• Opioid-naïve

• Patient is scheduled for a surgical procedure/procedures that is/are expected to require an analgesia with an opiate level medication.

• Patient who will remain hospitalized for at least 24 hours after dosing with the study drug.

• A negative urine pregnancy test at screening for females of childbearing potential

Exclusion Criteria:

• Patient is a lactating or breastfeeding female

• Patient has known allergy to oxycodone or any ingredient in oxycodone dosage form.