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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT01071057
Eligibility Criteria:
Inclusion Criteria:
* Children 5-18 years of age undergoing surgery at BCCH
* ASA I - II.
* Children receiving PCA morphine.
* Informed consent/assent provided by child/parent/guardian.
Exclusion Criteria
* Children with known abnormal developmental profile.
* Children with known opioid allergy.
* Inability/failure to obtain informed consent/assent from parent/guardian/child.
* Children receiving concurrent opioids.
* Children with pre-existing pruritus from non-opioid related cause.
* Children receiving PCA hydromorphone or fentanyl.
* ASA 3 and above.
* Children who require admission to the Pediatric Intensive Care Unit (PICU). - Children involved in any investigational drug trial within the previous one month.
* Any child in the study that experiences unmanageable pruritus within the protocol time frame and is converted to hydromorphone will continue to be monitored for 48 hours. However, this will be taken into account during statistical analysis of study results. Appropriate conventional rescue medication for pruritus (diphenhydramine 0.5mg/kg IV 4hrly PRN) will be provided for any child who continues to experience pruritus.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
18 Years
Study:
NCT01071057
Study Brief:
Protocol Section:
NCT01071057