Patient Controlled Analgesia Pharmacogenetic Study
|ClinicalTrials.gov Identifier: NCT01731873|
Recruitment Status : Enrolling by invitation
First Posted : November 22, 2012
Last Update Posted : August 1, 2017
|Condition or disease|
Opioids are the mainstay for treatment of postoperative pain in children. Experience dictates that opioids have narrow therapeutic indices and large inter-patient variability in response. This leads to serious side effects like respiratory depression in up to 50% of children undergoing invasive surgery, which can be fatal. Moreover, up to two-thirds of the inter-individual variability in response to opioids results from genetic variations both from variability in pain perception as well as response to the pain medicine. Much of the inter-individual variability in response to opioids following surgical procedures can be explained by Single Nucleotide Polymorphisms (SNPs) in a subset of the genes that encode proteins involved in pain perception, opioid transport/metabolism (pharmacokinetics), and opioid receptor signaling (pharmacodynamics). It is evident that there are particular children who are more susceptible to suffering side effects and having inadequate pain relief from opioids. Identifying genetic and non-genetic predictors for this susceptibility is vital for safe and effective analgesia in children. This is a critical knowledge gap in medical literature that significantly impacts pediatric pain management. The investigators' central hypothesis is that specific genetic polymorphisms in genes involved in pain perception, opioid transport, and opioid receptor signaling pathways contribute significantly to pain sensitivity, opioid side-effects, and analgesic efficacy in children.
The choice and dosing of opioids has thus far been largely empirical, with a frequent need to switch opioids and alter doses due to inherent differences in individuals. By this study, the investigators hope to determine the 'right' doses of the 'right' opioids for optimized and safe postoperative analgesia in children. Given the unexplored nature of this complex phenomenon, The investigators propose a comprehensive study to evaluate gene, drug, and surgical interactions, in a large sample of 650 children undergoing different surgeries, requiring patient controlled analgesia with opioids.
The proposed research is a preliminary step towards the investigators' long term goal to develop more effective, safer, and tailored pediatric opioid analgesia, by contributing to better understanding of the underlying genetic basis for variations in the sensitivity to pain, pain relief, and development of adverse effects from the extended use of postoperative intravenous opioids in children.
The data collected will include pain scores, opioid doses, incidence of side-effects of opioids ̶ including respiratory depression, sedation, vomiting, and itching. Data analysis will use advanced logistic regression techniques to uncover the association between the SNP variants and the response to specific opioids following various surgeries.
|Study Type :||Observational|
|Estimated Enrollment :||650 participants|
|Official Title:||Non-Interventional Pharmacogenetic Study of Patient / Proxy Controlled Analgesia in Children Undergoing Surgery|
|Actual Study Start Date :||May 22, 2011|
|Estimated Primary Completion Date :||May 21, 2021|
|Estimated Study Completion Date :||May 21, 2021|
- Number of adverse events [ Time Frame: 48 hours post-operatively ]Postoperative incidence of significant central adverse effects to opioids (respiratory depression, excessive sedation and postoperative nausea and vomiting - PONV)
- Post-operative pain [ Time Frame: 48 hours postoperatively ]Post-surgical pain scores at rest and on mobilization, opioid requirements/48 hours postoperatively.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731873
|United States, Ohio|
|Cincinnati Childrens Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Vidya Chidambaran, MD||Cincinnati Childrens Hospital Medical Center|