Status:
COMPLETED
Pharmacogenetic Morphine Spine Study
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Pain
Eligibility:
All Genders
10-18 years
Brief Summary
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 ...
Detailed Description
Safe and effective analgesia is an important unmet medical need in children. Despite efforts to promote non-pharmacologic interventions, drug treatment remains the standard of care for children experi...
Eligibility Criteria
Inclusion
- Children aged 10 to 18, inclusive, years of age
- Diagnosis of Idiopathic scoliosis, kyphosis and/or kyphoscoliosis
- Scheduled for spine fusion
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 2 2019
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT01839461
Start Date
July 1 2009
End Date
April 2 2019
Last Update
October 7 2019
Active Locations (1)
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1
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States, 45229