Patient Controlled Analgesia Pharmacogenetic Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier:
NCT01731873
First received: November 19, 2012
Last updated: November 28, 2012
Last verified: November 2012
  Purpose

The purpose of this research study is to identify factors and genes (the nucleic acid material that determines the makeup of the human body) that may be associated with how patients respond to pain medication, like morphine, which are called opioids. Though these pain medicines are used everyday, some patients have bad reactions from their use, like breathing problems, sedation, etc. It is not possible to completely predict which pain medicine is 'right' for a child. The investigators want to study factors that may be associated with pain sensitivity, pain medicine requirements after surgery and their side-effects. The investigators expect that the information obtained in this research study will help us to develop effective, safer, and tailored treatment options in the future.


Condition
Pain

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Non-Interventional Pharmacogenetic Study of Patient / Proxy Controlled Analgesia in Children Undergoing Surgery

Resource links provided by NLM:


Further study details as provided by Children's Hospital Medical Center, Cincinnati:

Primary Outcome Measures:
  • Number of adverse events [ Time Frame: 48 hours post-operatively ] [ Designated as safety issue: Yes ]
    Postoperative incidence of significant central adverse effects to opioids (respiratory depression, excessive sedation and postoperative nausea and vomiting - PONV)


Secondary Outcome Measures:
  • Post-operative pain [ Time Frame: 48 hours postoperatively ] [ Designated as safety issue: No ]
    Post-surgical pain scores at rest and on mobilization, opioid requirements/48 hours postoperatively.


Biospecimen Retention:   Samples With DNA

A database/ repository will be constructed for future research, analysis, and recruitment. De-identified study subjects' genetic information and their responses to pain and pain medications, side-effects will be included in the database. Blood specimens will be included in the repository for exploring potentially important SNPs and biomarkers in future. No patient identifiers will be included in the repository and there will be a confidential (access limited to investigators only) code or link between the repository/database and other information about the participant.


Estimated Enrollment: 650
Study Start Date: May 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

The investigators' long term goal is 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.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All children up to the age of 18 years undergoing surgery and clinically requiring Patient/Nurse/Parent Controlled analgesia with opioids (P/NCA), shall be eligible for the study

Criteria

Inclusion Criteria:

  • Children including and up to the age of 18 years
  • Scheduled for surgery requiring opioids PCA or PCA by proxy for postoperative pain relief

Exclusion Criteria:

  • Children with a history of liver or renal dysfunction
  • Patients with severe respiratory problems
  • Children with preoperative pain requiring opioids
  • Children on additional infusions like ketamine / lidocaine or dexmedetomidine peri - operatively
  • Children with BMI>30
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01731873

Locations
United States, Ohio
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
Principal Investigator: Vidya Chidambaran, MD Cincinnati Childrens Hospital Medical Center
  More Information

Publications:

Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT01731873     History of Changes
Other Study ID Numbers: 2010-2268
Study First Received: November 19, 2012
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital Medical Center, Cincinnati:
postoperative
pediatric
pharmacogenetic
opioid
perioperative
respiratory depression

ClinicalTrials.gov processed this record on October 23, 2014