Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-24 @ 12:44 PM
NCT ID:
NCT01839461
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT01839461
Study Brief:
Protocol Section:
NCT01839461