Pharmacogenetic Morphine Spine Study
CompletedNCT01839461
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 DNA material that determines the makeup of the human body) that may be associated with how children cope with pain and respond to pain medication. Morphine is a pain medication commonly prescribed after this surgery during the hospital stay. The investigators want to study factors that may be associated with morphine requirement after surgery and side-effects from morphine. They will use pharmacometric models to identify dosing guidelines and factors associated with individual variability in metabolism and efficacy/safety of morphine. They will also study psychological, genetic and epigenetic factors associated with acute and chronic post-surgical pain after spine surgery. 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
- Personalizing Perioperative Morphine Analgesia for Adolescents Undergoing Major Spine Surgeries
- Conditions
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Start date
- 2009-07
- Primary completion
- 2019-04-02
- Sex
- All
- Age range
- from 10 Years 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: * Children aged 10 to 18, inclusive, years of age * Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis * Scheduled for spine fusion Exclusion Criteria: * Known hypersensitivity to morphine * Patients on chronic pain medication. * Pregnant or breastfeeding females. * Children with a history of or active renal or liver disease. * Concomitant use of medication known to induce or inhibit CYP2D6 activity including paroxetine, fluoxetine, cimetidine, duloxetine or methadone. * Non-English speaking patients. * Developmental delay. * Children who have problems with pupil or pupillary reaction due to disease (such as amyloidosis, bilateral Horner's syndrome, familial dysautonomia, other major neurological disorders) or preoperative medications influencing pupillary size (anti-cholinergic, narcotic medications such as codeine in cough syrup) will be recruited but pupillometry will be deferred.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01839461