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 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT00884650
Eligibility Criteria:
Inclusion Criteria:
* Children with cerebral palsy between 3 and 17 years old.
* American Society of Anesthesiologists (ASA) intubation grade I, II or III.
* Ability of subject or primary caregivers to give informed consent, to understand what the study entails and to be able to complete the patient Pain Diary during the post-operative period. Subjects should be available for daily telephone follow-up until the data is completed and they should be able to return the completed Pain Diary to the Primary Investigator.
* Willingness and understanding of parent or guardian to have their child randomized to receive either the continuous infusion pain pump device or oral analgesics for their child's pain management.
* English or Spanish-speaking care parent or guardians who are able to complete the Pain Diary.
Exclusion Criteria:
* ASA IV or V,
* Known allergy or sensitivity to bupivacaine,
* Subjects who will have more than the above mentioned procedure performed during their surgical visit,
* Subjects with significant kidney or liver disease,
* Parents/guardians who are assessed by the PI or co-investigators to be unable or unwilling to complete the study's Pain Diary or behavioral tools, and
* Parents/guardians who are unwilling to allow their child to be randomly assigned to receive either the pain pump with oral analgesics or oral medications alone.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
17 Years
Study:
NCT00884650
Study Brief:
Protocol Section:
NCT00884650