N/A
N=54
Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT00884650 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. — 0.34; 0.24; 0.39; 0.19 mg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- oral analgesic (Drug); intravenous analgesic per pump (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. |
0.34; 0.24; 0.39; 0.19; 0.29; 0.17 | — |
| PRIMARY The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. |
6.70; 3.79; 5.17; 2.78; 3.43; 1.79 | — |
| SECONDARY Parent and Patient Satisfaction With the Post Operative Pain Management. |
26; 22; 7; 1; 28 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00884650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.