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:
2025-12-25 @ 4:35 AM
Ignite Modification Date:
2025-12-25 @ 4:35 AM
NCT ID:
NCT01394718
Eligibility Criteria:
Inclusion Criteria:
Subjects 10-18 years who are status post anterior or posterior spine fusion surgery
Exclusion Criteria:
1. All patients requiring mechanical ventilation post-operatively, continuous infusions of sedative, or continuous infusions of alternate opiates (i.e. fentanyl)
2. Patients with hepatic dysfunction
3. Patients with chronic opiate requirements
4. Pregnant or lactating females
5. Patients placed on opiates other than morphine or hydromorphone
6. Patients with opiate or acetaminophen allergies
7. Patients placed on alternate analgesic adjuncts (i.e. ketamine, etc)
8. Patients who receive intrathecal opiates
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT01394718
Study Brief:
Protocol Section:
NCT01394718