Patient Controlled Analgesia Pharmacogenetic Study

NCT01731873 | Completed

• 1 other identifier: 2010-2268
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

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 acute and chronic post-surgical pain as well as develop pharmacometric models for response to opioids, like morphine and hydromorphone. While children undergioing different surgeries will be recruited for acute outcomes, children undergoing spine fusion will be followed for 10-12 months for evaluation of psychological and genomic factors affecting chronic post-surgical pain, with a goal of identifying genetic and epigenetic risk models for prediction of acute and chronic post-surgical pain. Although opioids are used every day, some children have bad reactions from their use, like breathing problems, sedation, etc. The investigators want to study factors that may be associated with pain sensitivity, opioid requirements after surgery, their metabolism, efficacy and their side-effects. The investigators expect that the information obtained in this research study will help to develop effective, safer, and tailored treatment options in the future.

Conditions

Pain

Keywords

postoperative pain; children; pharmacogenetic; opioid adverse effects; respiratory depression; analgesia; genetic polymorphisms; chronic postsurgical pain

Outcome Measures

Primary Outcomes (2)

• Post-operative pain

  Post-surgical pain scores at rest and on mobilization, opioid requirements/48 hours

  48 hours post-operatively

• Chronic post-surgical pain

  Pain scores several months after surgery

  6-12 months after surgery

Secondary Outcomes (2)

• Opioid pharmacometrics

  24-48 hours postoperatively

• Chronic post-surgical disability

  6-12 months after surgery

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children (weighing at least 5 kg, and up to and including 18 year olds) undergoing surgery requiring postoperative Patient Controlled Analgesia (PCA) or PCA by Proxy with opioids (P/NCA), shall be eligible for the study, if inclusion/exclusion criteria are met.

You may qualify if:

• Children up to and including the age of 18 years;
• Children weighing at least 5kg at time of surgery; and
• Children scheduled for surgery requiring opioids PCA or PCA by proxy for postoperative pain relief.

You may not qualify if:

• Children with a history of active liver or renal dysfunction (generally indicated by current abnormal lab results);
• Patients with severe respiratory problems (indicated by an ASA rating \> 4, or oxygen/CPAP/BiPAP dependence);
• Children with recent chronic preoperative pain, especially those requiring opioids or nerve pain medications within the last 6 months prior to surgery;
• Children who are anticipated to receive ketamine (i.e., injection, infusion, IM) or dexmedetomidine/sufentanil/lidocaine infusions perioperatively;
• Children with BMI \> 35;
• Children with certain genetic diseases or chromosomal abnormalities known to affect pain perception and/or breathing; and
• Non-English speaking patients.

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (94)

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• Park MY, Hastie T. Penalized logistic regression for detecting gene interactions. Biostatistics. 2008 Jan;9(1):30-50. doi: 10.1093/biostatistics/kxm010. Epub 2007 Apr 11.

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• Van Slyke DA, Walker LS. Mothers' responses to children's pain. Clin J Pain. 2006 May;22(4):387-91. doi: 10.1097/01.ajp.0000205257.80044.01.

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• Chidambaran V, Zhang X, Pilipenko V, Chen X, Wronowski B, Geisler K, Martin LJ, Barski A, Weirauch MT, Ji H. Methylation quantitative trait locus analysis of chronic postsurgical pain uncovers epigenetic mediators of genetic risk. Epigenomics. 2021 Apr;13(8):613-630. doi: 10.2217/epi-2020-0424. Epub 2021 Apr 6.

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Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Pain; Pain, Postoperative; Respiratory Insufficiency; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Vidya Chidambaran, MD

  Cincinnati Childrens Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2012
• First Posted: November 22, 2012
• Study Start: January 17, 2012
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: September 3, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)