Pharmacogenetic Morphine Spine Study
Completed
Conditions studied: Pain
In brief
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.
Key facts
- Study ID
- NCT01839461
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 137
- Starts
- 2009-07-01
- Expected to finish
- 2019-04-02
- Last updated by the study team
- 2019-10-07
Who can join
Age: 10 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Children aged 10 to 18, inclusive, years of age
- Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis
- Scheduled for spine fusion
You may not qualify if…
- 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.
Where it is running
- Cincinnati Childrens Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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