Cerebral Palsy Clinical Trial
Official title:
Comparing the Effectiveness of an Anesthetic Continuous-infusion Device to Oral Analgesia in Orthopedic Postoperative Pain Control of Children With Cerebral Palsy
NCT number | NCT00884650 |
Other study ID # | 04-0981 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2005 |
Est. completion date | April 2008 |
Verified date | August 2021 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | April 2008 |
Est. primary completion date | April 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 17 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The Children's Hospital, Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | 4 days | |
Primary | 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). | 4 days | |
Secondary | Parent and Patient Satisfaction With the Post Operative Pain Management. | Parent responses to questions about pain management traditional paper-based Q method (TPQM) questionnaire. | 4 days |
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