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PG and PK of Oxycodone to Personalize Post-op Pain Management Following Surgery in Children
NCT03495388 · View on ClinicalTrials.gov ↗
Study Summary
Each year, in the U.S. alone, \>6 million children undergo painful surgery; up to 50% of them experience significant and serious side effects with opioids and inadequate pain relief. Though 60% of this inter-individual variability in responses results from genetic variations, there is an almost complete lack of understanding of how specific genetic variability affects pain and of the adverse effects of opioids, especially in children. In this project the investigators will focus on oxycodone, a standard and preferred post-surgical oral analgesic in children The purpose of this research is to study serious immediate and long-term clinical problems from both surgical pain and oxycodone use in children and adolescents to improve the safety and effectiveness of surgical pain relief. The long-term goals are to improve the safety and effectiveness of surgical pain relief with opioids (a class of drugs/pain relievers) and to minimize the societal burden of disabling Chronic Persistent Surgical Pain (CPSP, which is pain that persists even after the expected healing time from surgery) and Opioid Dependence (OD) by preoperative risk predictions and personalized care with the right dose of the right pain medication for each child. The overall objective is to determine the impact of risk factors on oxycodone's immediate and long-term negative postoperative outcomes and to personalize dosing in children undergoing outpatient and major inpatient surgery.
Conditions Studied
Interventions
- DRUG Oxycodone
Study Locations (2)
Indiana
- Riley Hospital for Children — Indianapolis
Pennsylvania
- UPMC Children's Hospital — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 129 participants |
| Start Date | 2018-04-01 |
| Est. Completion | 2022-06-15 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03495388
The ClinicalTrials.gov registry entry for NCT03495388 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 129 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Senthil Sadhasivam, which has 35 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Postoperative Pain appearing as the primary indexed condition, and to 1 intervention — of which Oxycodone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03495388 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Indiana, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03495388 about?
NCT03495388 is a clinical study titled "PG and PK of Oxycodone to Personalize Post-op Pain Management Following Surgery in Children". Each year, in the U.S. alone, \>6 million children undergo painful surgery; up to 50% of them experience significant and serious side effects with opioids and inadequate pain relief. Though 60% of this inter-individual variability in responses results from genetic variations, there is an almost comp...
What is the current status of trial NCT03495388?
This trial is currently completed. The enrollment target is 129 participants. The study started on 2018-04-01. Estimated completion is 2022-06-15.
What conditions does trial NCT03495388 study?
This clinical trial studies the following conditions: Postoperative Pain, Opioid Dependence. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03495388?
The interventions under investigation include: Oxycodone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03495388?
This trial is sponsored by Senthil Sadhasivam, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03495388 being conducted?
This trial has 2 study locations across Indiana, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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