Population Pharmacokinetic-Pharmacodynamic Study of Intravenous Oxycodone in Malaysian Population
Condition: Pain
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Oxycodone (14-hydroxy-7,8 dihydrocodeinone) is a strong, semisynthetic thebaine derivative
      µ-opioid receptor agonist. This drug is an effective alternative to morphine for
      moderate-to-severe pain. Oxycodone has been used parenterally or orally for perioperative
      analgesia or for cancer pain relief. The drug has a longer analgesic action than morphine. In
      terms of analgesic potency, intravenous oxycodone is about 1.6 times

      The adverse effects of oxycodone are mostly similar to those of other opioids. Oxycodone,
      however, does not cause histamine release. The drug induces less nausea and vomiting, less
      sedating, and less central nervous system excitatory effects than morphine.

      A large between-subject variability in pharmacokinetic properties of oxycodone has been
      observed. The variability could be attributed to the different body size and age-related
      difference in drug elimination organ system function. A 2-compartment first-order open model
      describes oxycodone pharmacokinetics in Finnish children (age 5.4±2.1 years) after an
      intravenous bolus dose of 0.1 mg kg-1 for post ophthalmic surgery pain relief. The authors
      reported a mean clearance (CL) and the steady-state volume of distribution (Vss) of oxycodone
      15.2 mL min-1 kg-1 (0.912 L h-1 kg-1) and 2.1 L kg-1 respectively. A greater ventilator
      depression than comparable analgesic doses of other opioids was also observed. A
      pharmacokinetic study carried out in 9 young Finnish adult surgical patients reveals a
      clearance of 0.78 L min-1 (46.8 L h-1) and a volume of distribution (V) of 2.60 L kg-1. The
      mean area under the curve (AUC)( t=0,12) ratio of noroxycodone (main metabolite) to oxycodone
      is 0.33. In a study on 69 Japanese adults (mean age 66 years, mean weight 52.8 kg) receiving
      intravenous oxycodone for cancer pain relief, a one-compartment first-order open model
      describes the pharmacokinetics of oxycodone. The mean CL and volume of distribution (V) are
      24.6 L h-1 and 214 L or 4.053 L kg-1.
    

Intervention name(s): Oxycodone
Intervention type(s): Drug
Intervention description(s): Pain Management
Other intervention name(s): OxyNorm
Intervention MeSH terms: Oxycodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain Management; Pharmacokinetics; Pharmacodynamics