Cerebral Palsy
Conditions
Keywords
Pain, Pain management, Cerebral Palsy
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.
Interventions
DRUGoral analgesic
per clinical standard of care
DRUGintravenous analgesic per pump
per clinical standard of care
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | 4 days | 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. | 4 days | Pain scores were assessed using a Visual Analog Scale. Possible scores range from 0 (no pain) to 10 (Worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parent and Patient Satisfaction With the Post Operative Pain Management. | 4 days | Parent responses to questions about pain management traditional paper-based Q method (TPQM) questionnaire. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Group 1 will receive oral analgesia only | 16 |
| Group 2 Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia | 21 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Admitted Post-Op | 1 | 0 |
| Overall Study | Did not return complete pain diaries | 7 | 7 |
| Overall Study | Femoral Stress Fracture | 1 | 0 |
| Overall Study | Pain Pump Complication | 0 | 1 |
Baseline characteristics
| Characteristic | Group 2 | Group 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 21 Participants | 16 Participants | 37 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.7 years STANDARD_DEVIATION 3.27 | 7.1 years STANDARD_DEVIATION 2.59 | 7.89 years STANDARD_DEVIATION 3.08 |
| Region of Enrollment United States | 21 participants | 16 participants | 37 participants |
| Sex: Female, Male Female | 11 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Male | 10 Participants | 10 Participants | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 21 |
| other Total, other adverse events | 0 / 16 | 0 / 21 |
| serious Total, serious adverse events | 0 / 16 | 0 / 21 |
Outcome results
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)
Time frame: 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Analgesia Only | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Day 0 | 0.34 mg/kg | Standard Deviation 0.26 |
| Oral Analgesia Only | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Day 3 | 0.20 mg/kg | Standard Deviation 0.27 |
| Oral Analgesia Only | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Day 1 | 0.39 mg/kg | Standard Deviation 0.36 |
| Oral Analgesia Only | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Total | 1.22 mg/kg | Standard Deviation 1.1 |
| Oral Analgesia Only | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Day 2 | 0.29 mg/kg | Standard Deviation 0.33 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Total | 0.68 mg/kg | Standard Deviation 0.66 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Day 0 | 0.24 mg/kg | Standard Deviation 0.2 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Day 2 | 0.17 mg/kg | Standard Deviation 0.19 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Day 3 | 0.09 mg/kg | Standard Deviation 0.16 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period. | Day 1 | 0.19 mg/kg | Standard Deviation 0.2 |
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).
Time frame: 4 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral Analgesia Only | The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. | Day 0 | 6.70 score on a scale | Standard Deviation 3.21 |
| Oral Analgesia Only | The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. | Day 1 | 5.17 score on a scale | Standard Deviation 2.31 |
| Oral Analgesia Only | The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. | Day 3 | 2.10 score on a scale | Standard Deviation 1.68 |
| Oral Analgesia Only | The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. | Day 2 | 3.43 score on a scale | Standard Deviation 2.06 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. | Day 3 | 1.74 score on a scale | Standard Deviation 2.1 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. | Day 0 | 3.79 score on a scale | Standard Deviation 2.86 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. | Day 1 | 2.78 score on a scale | Standard Deviation 1.99 |
| Anesthetic Continuous-Infusion + Oral Analgesia | The Amount of Pain Analyzed From Pain Scores for Each of the 4 Days. | Day 2 | 1.79 score on a scale | Standard Deviation 1.44 |
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.
Time frame: 4 days
Population: Arms are combined because no outcome measure data is available for separate arms. We have made multiple attempts to contact the PI and study team to obtain data for separate arms. However, the PI has retired and could not be reached, and the study team either could not be reached, has left the university, or did not have the data. Data is only available for 30 parents.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Analgesia Only | Parent and Patient Satisfaction With the Post Operative Pain Management. | Parent felt that pain medicine was able to take away most of their child's pain | 26 Participants |
| Oral Analgesia Only | Parent and Patient Satisfaction With the Post Operative Pain Management. | Parent was Very Satisfied with child's pain management | 22 Participants |
| Oral Analgesia Only | Parent and Patient Satisfaction With the Post Operative Pain Management. | Parent was Satisfied with child's pain management. | 7 Participants |
| Oral Analgesia Only | Parent and Patient Satisfaction With the Post Operative Pain Management. | Parent was Dissatisfied with child's pain management. | 1 Participants |
| Oral Analgesia Only | Parent and Patient Satisfaction With the Post Operative Pain Management. | Parent would want their child's pain managed in the same way after another surgery | 28 Participants |