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



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:3 - 17
Updated:10/14/2017
Start Date:June 2005
End Date:April 2008

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Comparing the Effectiveness of an Anesthetic Continuous-infusion Device to Oral Analgesia in Orthopedic Postoperative Pain Control of Children With Cerebral Palsy

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.

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 metal work removal.

Subjects will be randomized into two groups: the first group will have an anesthetic pain
pump device supplemented with oral analgesia and the second group will only receive oral
analgesia. The anesthetic continuous device will be used continuously for 48 hours and with a
flow rate of 2ml/hour of 0.25% bupivacaine diluted in accordance to patient weight. Subjects
in both groups will receive oral analgesia according to their pain requirements. The amount
of oral analgesia used will be documented over 12-hour intervals in a patient diary over a 4
day period. Subjects will have their pain score assessed daily with the use of the
Non-Communicating Children's Pain Checklist-Postoperative Version. Their overall satisfaction
with post-operative pain management will be assessed at the end of the study with the use of
the Parent Total Quality Pain Management questionnaire.

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.
We found this trial at
1
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Aurora, Colorado 80045
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Aurora, CO
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