Personalizing Perioperative Analgesia in Children
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|ClinicalTrials.gov Identifier: NCT01140724|
Recruitment Status : Recruiting
First Posted : June 9, 2010
Last Update Posted : July 28, 2020
|Condition or disease|
Measures and Procedures: Participants will receive standard care, standard anesthetic and an intraoperative dose of morphine per the clinical team.
Research procedures will include:
- Blood draws for genotyping candidate genes and exploratory genes
- Standardized PACU (post anesthesia care unit) Protocol: Subjective pain assessments: Numerical Rating Scale (NRS) 0 to 10. Objective assessment with FLACC (facial expression; leg movement; activity; cry; and consolability) scale, 0-10.
- Significant postoperative pain will be managed in the PACU with rescue doses of morphine and opioids by the clinical team. Analgesic interventions and morphine requirements are collected
- Effects of opioids on pupil measures
- Respiratory response to 5% carbon dioxide preoperatively and postoperatively (first 350 patients only). Another measure of end tidal carbon dioxide will be implemented when the device is clinically available.
- Serial blood draws for morphine pharmacokinetic modeling (through subject #351).
- Opioid adverse effects in PACU and at home.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
- Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a higher susceptibility to pain and morphine requirement. [ Time Frame: After tonsillectomy surgery (duration of post anesthesia care unit stay) ]Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a relationship to more pain and need for a higher morphine requirement.
- Evaluate relationship of pupil reaction and response to 5% carbon dioxide to adverse effects of morphine [ Time Frame: After tonsillectomy surgery (duration of post anesthesia care unit stay) ]
- Evaluate contribution of polymorphisms in genes to variability in codeine response in children with CYP2D6 genotypes predictive of extensive metabolizer or ultra-extensive metabolizer phenotypes [ Time Frame: During tonsilectomies ]Evaluate contribution of polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to variability in codeine response in children with CYP2D6 genotypes predictive of extensive metabolizer or ultra-extensive metabolizer phenotypes
- Evaluate whether machine learning techniques can be used to predict pain response, opioid responses and morphine usage requirements in patients [ Time Frame: After tonsilectomy surgery data collection ]Evaluate whether machine learning techniques can be used to predict pain response, opioid responses and morphine usage requirements in patients solely using information extracted from the medical record as well as in combination with other genetic information
Biospecimen Retention: Samples With DNA
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): NCT01140724
|Contact: Senthilkumar Sadhasivam, MD, MPH||317-948-3845||ssadhasivam@IUHealth.org|
|United States, Indiana|
|Riley Hospital for Children||Recruiting|
|Indianapolis, Indiana, United States, 46202|
|Contact: Senthilkumar Sadhasivam, MD, MPH 317-948-3845 ssadhasivam@IUHealth.org|
|Contact: Mary Heskett, RN 317-944-4042 firstname.lastname@example.org|
|Principal Investigator: Senthilkumar Sadhasivam, MD, MPH|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center||Completed|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Senthilkumar Sadhasivam, MD, MPH||Indiana University|