Back to resultsManaging Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
oral analgesic
intravenous analgesic per pump
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy focused on measuring Pain, Pain management, Cerebral Palsy
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.
Sites / Locations
- The Children's Hospital, Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oral Analgesic Only
anesthetic continuous-infusion + oral analgesia
Arm Description
Group 1 will receive oral analgesic only
Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia
Outcomes
Primary Outcome Measures
The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.
Results of Mean and total Medication administered between the 2 groups over a 4 day period (Mean Medication Administered in mg/kg; SD)
The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days.
Pain scores were assessed using a Visual Analog Scale. Possible scores range from 0 (no pain) to 10 (Worst possible pain).
Secondary Outcome Measures
Parent and Patient Satisfaction With the Post Operative Pain Management.
Parent responses to questions about pain management traditional paper-based Q method (TPQM) questionnaire.
Full Information
NCT ID
NCT00884650
First Posted
April 16, 2009
Last Updated
August 4, 2021
Sponsor
University of Colorado, Denver
1. Study Identification
Unique Protocol Identification Number
NCT00884650
Brief Title
Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump
Official Title
Comparing the Effectiveness of an Anesthetic Continuous-infusion Device to Oral Analgesia in Orthopedic Postoperative Pain Control of Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Pain, Pain management, Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral Analgesic Only
Arm Type
Active Comparator
Arm Description
Group 1 will receive oral analgesic only
Arm Title
anesthetic continuous-infusion + oral analgesia
Arm Type
Active Comparator
Arm Description
Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia
Intervention Type
Drug
Intervention Name(s)
oral analgesic
Intervention Description
per clinical standard of care
Intervention Type
Drug
Intervention Name(s)
intravenous analgesic per pump
Intervention Description
per clinical standard of care
Primary Outcome Measure Information:
Title
The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.
Description
Results of Mean and total Medication administered between the 2 groups over a 4 day period (Mean Medication Administered in mg/kg; SD)
Time Frame
4 days
Title
The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days.
Description
Pain scores were assessed using a Visual Analog Scale. Possible scores range from 0 (no pain) to 10 (Worst possible pain).
Time Frame
4 days
Secondary Outcome Measure Information:
Title
Parent and Patient Satisfaction With the Post Operative Pain Management.
Description
Parent responses to questions about pain management traditional paper-based Q method (TPQM) questionnaire.
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Chang, MD
Organizational Affiliation
Children's Hospital Colorado
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital, Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
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Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump
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