PG and PK of Oxycodone to Personalize Post-op Pain Management Following Surgery in Children
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain, Psychiatric |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 8 - 18 |
| Updated: | 10/26/2018 |
| Start Date: | April 1, 2018 |
| End Date: | March 2022 |
| Contact: | Senthilkumar Sadhasivam, MD, MPH |
| Email: | ssadhasivam@IUHealth.org |
| Phone: | (317) 948-3845 |
Pharmacogenetics and Pharmacokinetics of Oxycodone to Personalize Postoperative Pain Management Following Major Inpatient 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 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.
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.
Research procedures will include:
1. Pre-operative blood draw for genotyping candidate genes and exploratory genes and for
future similar studies will be collected.
2. Standardized pre-, intra-, and post-operative care will be received by all participants.
The study team will record medical history, demographic information, concomitant
medications, vitals, pain scores, post-operative nausea and vomiting, and all
medications given post-surgery for pain management throughout the participants
in-patient stay.
3. Psychological questionnaires to assess pain, risk of developing OD and chronic pain,
anxiety and depression will be administered pre-operatively, and 48-72 hours, 7-14 days,
2 months, 3 months, 6 months and 12 months post-operatively.
4. Quantitative Sensory Testing will be performed on up to 100 participants
pre-operatively, and 48-72 hours,3 months and 12 months post-operatively.
5. Serial blood draws for oxycodone and methadone pharmacokinetic modeling will be
collected from up to 200 participants. QTc measurements will also be recorded from pre-
and post-operative EKGs for those participants in which methadone pharmacokinetic blood
samples are collected.
1. Pre-operative blood draw for genotyping candidate genes and exploratory genes and for
future similar studies will be collected.
2. Standardized pre-, intra-, and post-operative care will be received by all participants.
The study team will record medical history, demographic information, concomitant
medications, vitals, pain scores, post-operative nausea and vomiting, and all
medications given post-surgery for pain management throughout the participants
in-patient stay.
3. Psychological questionnaires to assess pain, risk of developing OD and chronic pain,
anxiety and depression will be administered pre-operatively, and 48-72 hours, 7-14 days,
2 months, 3 months, 6 months and 12 months post-operatively.
4. Quantitative Sensory Testing will be performed on up to 100 participants
pre-operatively, and 48-72 hours,3 months and 12 months post-operatively.
5. Serial blood draws for oxycodone and methadone pharmacokinetic modeling will be
collected from up to 200 participants. QTc measurements will also be recorded from pre-
and post-operative EKGs for those participants in which methadone pharmacokinetic blood
samples are collected.
Inclusion Criteria:
- Boy and girls
- All races
- ASA physical status 1 and 2
- Scheduled for pectus excavatum repair or idiopathic scoliosis spinal fusion
- Children with OSA will be included but stratified as they have more opioid-related
complications.
Exclusion Criteria:
- Allergy to oxycodone or methadone
- Developmental delay
- Neurological disorder
- Renal or liver disease
- Pre-operative pain requiring analgesics
- On inhibitors or inducers of CYP2D6 and CYP3A
- Cannot read, write and speak English fluently
We found this trial at
1
site
705 Riley Hospital Dr
Indianapolis, Indiana 46202
Indianapolis, Indiana 46202
(317) 944-5000
Principal Investigator: Senthilkumar Sadhasivam, MD, MPH
Phone: 317-948-3845
Riley Hospital for Children Riley Hospital for Children at IU Health is a place of...
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