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

Completed · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT00884650

Run by

University of Colorado, Denver

People needed

54

Starts

2005-06-01

Expected to finish

2008-04-01

Last updated by the study team

2021-08-27

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Children's Hospital, Denver — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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