PG and PK of Oxycodone to Personalize Post-op Pain Management Following Surgery in Children
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Opioid Dependence
- Postoperative Pain
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Between 8 years and 18 years
- Gender
- Both males and females
Description
Research procedures will include: Pre-operative blood draw for genotyping candidate genes and exploratory genes and for future similar studies will be collected. Standardized pre-, intra-, and post-operative care will be received by all participants. The study team will record medical history, demog...
Research procedures will include: Pre-operative blood draw for genotyping candidate genes and exploratory genes and for future similar studies will be collected. 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. 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. Quantitative Sensory Testing will be performed on up to 100 participants pre-operatively, and 48-72 hours,3 months and 12 months post-operatively. 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.
Tracking Information
- NCT #
- NCT03495388
- Collaborators
- Children's Hospital Medical Center, Cincinnati
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Principal Investigator: Senthilkumar Sadhasivam, MD, MPH Indiana Univeristy