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Population Pharmacokinetic-Pharmacodynamic Study of Intravenous Oxycodone in Children

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ClinicalTrials.gov Identifier: NCT02728648
Recruitment Status : Suspended (Difficult to recruit patients)
First Posted : April 5, 2016
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Chaw Sook Hui, University of Malaya

Brief 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.

Condition or disease Intervention/treatment Phase
Pain Drug: Oxycodone Phase 4

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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Population Pharmacokinetic-Pharmacodynamic Study of Intravenous Oxycodone in Children
Actual Study Start Date : April 2016
Actual Primary Completion Date : April 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active
Open label IV Oxycodone 0.1 mg/kg Bolus Pharmacokinetic-Pharmacodynamic Study
Drug: Oxycodone
Pain Management
Other Name: OxyNorm




Primary Outcome Measures :
  1. Clearance (CL) [ Time Frame: 18 months ]
    Clearance: volume of plasma from which oxycodone is completely removed per unit time;


Secondary Outcome Measures :
  1. Volume of distribution of IV oxycodone [ Time Frame: 18 months ]
    Volume of distribution: theoretical volume that would be necessary to contain the total amount of oxycodone at the same concentration that it is observed in the blood plasma.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728648


Locations
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Malaysia
Faculty of Medicine, University of Malaya
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603
Sponsors and Collaborators
University of Malaya
Investigators
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Principal Investigator: Sook Hui Chaw, M.Med University of Malaya

Publications:
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Responsible Party: Chaw Sook Hui, Dr, University of Malaya
ClinicalTrials.gov Identifier: NCT02728648     History of Changes
Other Study ID Numbers: 20162-2143
First Posted: April 5, 2016    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Chaw Sook Hui, University of Malaya:
Pain Management
Pharmacokinetics
Pharmacodynamics

Additional relevant MeSH terms:
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Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents