Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine which pain management strategy continuous analgesic pump or orally-should be used in the management of children with cerebral palsy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital Colorado; University of Colorado, Denver
• Treatments: Analgesics

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.