NCT01731873

Patient Controlled Analgesia Pharmacogenetic Study

Completed Last updated 3 September 2020

What this trial tests

trial in Pain in 182 participants. Completed in 30 April 2019.

Timeline

17 January 2012

Primary endpoint
30 April 2019

30 April 2019

Quick facts

Lead sponsor	Children's Hospital Medical Center, Cincinnati
Status	Completed
Study type	OBSERVATIONAL
Enrollment	182
Start date	17 January 2012
Primary completion	30 April 2019
Estimated completion	30 April 2019
Sites	1 location across United States

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Children's Hospital Medical Center, Cincinnati

Who can join

Under 18, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Predicting the pain continuum after adolescent idiopathic scoliosis surgery: A prospective cohort study.
   Chidambaran V, Ding L, Moore DL, Spruance K, et al · · 2017 · cited 96× · PMID 28346762 · DOI 10.1002/ejp.1025
2. DNA methylation at the mu-1 opioid receptor gene (<i>OPRM1</i>) promoter predicts preoperative, acute, and chronic postsurgical pain after spine fusion.
   Chidambaran V, Zhang X, Martin LJ, Ding L, et al · · 2017 · cited 56× · PMID 28533693 · DOI 10.2147/pgpm.s132691
3. Enrichment of Genomic Pathways Based on Differential DNA Methylation Associated With Chronic Postsurgical Pain and Anxiety in Children: A Prospective, Pilot Study.
   Chidambaran V, Zhang X, Geisler K, Stubbeman BL, et al · · 2019 · cited 34× · PMID 30639570 · DOI 10.1016/j.jpain.2018.12.008
4. Cost-effectiveness of intravenous acetaminophen and ketorolac in adolescents undergoing idiopathic scoliosis surgery.
   Chidambaran V, Subramanyam R, Ding L, Sadhasivam S, et al · · 2018 · cited 22× · PMID 29377376 · DOI 10.1111/pan.13329
5. The role of cytokines in acute and chronic postsurgical pain after major musculoskeletal surgeries in a quaternary pediatric center.
   Chidambaran V, Duan Q, Pilipenko V, Glynn SM, et al · · 2024 · cited 8× · PMID 39222726 · DOI 10.1016/j.bbi.2024.08.056
6. Systems Biology Guided Gene Enrichment Approaches Improve Prediction of Chronic Post-surgical Pain After Spine Fusion.
   Chidambaran V, Pilipenko V, Jegga AG, Geisler K, et al · · 2021 · cited 8× · PMID 33868360 · DOI 10.3389/fgene.2021.594250
7. Methylation quantitative trait locus analysis of chronic postsurgical pain uncovers epigenetic mediators of genetic risk.
   Chidambaran V, Zhang X, Pilipenko V, Chen X, et al · · 2021 · cited 5× · PMID 33820434 · DOI 10.2217/epi-2020-0424