Recruitment

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