Patient Controlled Analgesia Pharmacogenetic Study
CompletedNCT01731873
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Non-Interventional Pharmacogenetic Study of Patient / Proxy Controlled Analgesia in Children Undergoing Surgery
- Conditions
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Start date
- 2012-01-17
- Primary completion
- 2019-04-30
- Sex
- All
- Age range
- to 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion criteria include: 1. Children up to and including the age of 18 years; 2. Children weighing at least 5kg at time of surgery; and 3. Children scheduled for surgery requiring opioids PCA or PCA by proxy for postoperative pain relief. Exclusion criteria include: 1. Children with a history of active liver or renal dysfunction (generally indicated by current abnormal lab results); 2. Patients with severe respiratory problems (indicated by an ASA rating \> 4, or oxygen/CPAP/BiPAP dependence); 3. Children with recent chronic preoperative pain, especially those requiring opioids or nerve pain medications within the last 6 months prior to surgery; 4. Children who are anticipated to receive ketamine (i.e., injection, infusion, IM) or dexmedetomidine/sufentanil/lidocaine infusions perioperatively; 5. Children with BMI \> 35; 6. Children with certain genetic diseases or chromosomal abnormalities known to affect pain perception and/or breathing; and 7. Non-English speaking patients.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01731873