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 @ 1:09 AM
Ignite Modification Date:
2025-12-25 @ 1:09 AM
NCT ID:
NCT01737593
Eligibility Criteria:
Inclusion Criteria:
* Patients' ≥ 6 months - 6 years
* Patients must meet criteria for American Society of Anesthesiologists (ASA) physical status I, II.
* Patients must not be pre-medicated.
* Parents must give written consent on the surgery day and be able to sign informed consent form on the surgery day.
* Undergoing BMT surgery only.
Exclusion Criteria:
* Patients' \<6 months and \>6 years.
* Patients with known allergies to any of the medications used in this study.
* Patients with ASA status III \& IV.
* Patients taking prescription pain medications prior to surgery.
* Patients taking medication that can cause drowsiness or alter mental status (eg. benzodiazepines, cough suppressants, diphenhydramine)
* Patients with significant history of psychiatric illness, neurologic disease (seizure disorder requiring medication therapy), and developmental delay.
* Patients have been pre-medicated.
* Patients undergoing other procedures that would prolong anesthetic exposure or confound post-operative pain.
* Intra-op complication that would require prolonged anesthetic exposure.
* If patient took acetaminophen prior to surgery and was not supposed to do so
* Patients that received ketorolac or additional analgesia during surgery.
* Patients that have liver disease.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Months
Maximum Age:
6 Years
Study:
NCT01737593
Study Brief:
Protocol Section:
NCT01737593