Status:
COMPLETED
Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump
Lead Sponsor:
University of Colorado, Denver
Conditions:
Cerebral Palsy
Eligibility:
All Genders
3-17 years
Phase:
NA
Brief 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.
Detailed Description
A prospective randomized controlled trial will be performed on up to 150 subjects who will undergo a tendoachilles lengthening, Strayer's procedure, epiphysiodesis of the femur or femoral osteotomy me...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00884650
Start Date
June 1 2005
End Date
April 1 2008
Last Update
August 27 2021
Active Locations (1)
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1
The Children's Hospital, Denver
Aurora, Colorado, United States, 80045