Trial Outcomes & Findings for Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump (NCT NCT00884650)
NCT ID: NCT00884650
Last Updated: 2021-08-27
Results Overview
Results of Mean and total Medication administered between the 2 groups over a 4 day period (Mean Medication Administered in mg/kg; SD)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
4 days
Results posted on
2021-08-27
Participant Flow
Participant milestones
| Measure |
Oral Analgesia Only
Group 1 will receive oral analgesia only
|
Anesthetic Continuous-Infusion + Oral Analgesia
Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
29
|
|
Overall Study
COMPLETED
|
16
|
21
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Oral Analgesia Only
Group 1 will receive oral analgesia only
|
Anesthetic Continuous-Infusion + Oral Analgesia
Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
|
|---|---|---|
|
Overall Study
Did not return complete pain diaries
|
7
|
7
|
|
Overall Study
Admitted Post-Op
|
1
|
0
|
|
Overall Study
Femoral Stress Fracture
|
1
|
0
|
|
Overall Study
Pain Pump Complication
|
0
|
1
|
Baseline Characteristics
Managing Post-operative Pain in Children With Cerebral Palsy Using a Pain Pump
Baseline characteristics by cohort
| Measure |
Group 1
n=16 Participants
Group 1 will receive oral analgesia only
|
Group 2
n=21 Participants
Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.1 years
STANDARD_DEVIATION 2.59 • n=5 Participants
|
8.7 years
STANDARD_DEVIATION 3.27 • n=7 Participants
|
7.89 years
STANDARD_DEVIATION 3.08 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
21 participants
n=7 Participants
|
37 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 daysResults of Mean and total Medication administered between the 2 groups over a 4 day period (Mean Medication Administered in mg/kg; SD)
Outcome measures
| Measure |
Oral Analgesia Only
n=16 Participants
Group 1 will receive oral analgesia only
|
Anesthetic Continuous-Infusion + Oral Analgesia
n=21 Participants
Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
|
|---|---|---|
|
The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.
Day 0
|
0.34 mg/kg
Standard Deviation 0.26
|
0.24 mg/kg
Standard Deviation 0.2
|
|
The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.
Day 1
|
0.39 mg/kg
Standard Deviation 0.36
|
0.19 mg/kg
Standard Deviation 0.2
|
|
The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.
Day 2
|
0.29 mg/kg
Standard Deviation 0.33
|
0.17 mg/kg
Standard Deviation 0.19
|
|
The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.
Day 3
|
0.20 mg/kg
Standard Deviation 0.27
|
0.09 mg/kg
Standard Deviation 0.16
|
|
The Amount of Oral Analgesic Each Subject Consumed Over the 4-day Study Period.
Total
|
1.22 mg/kg
Standard Deviation 1.10
|
0.68 mg/kg
Standard Deviation 0.66
|
PRIMARY outcome
Timeframe: 4 daysPain scores were assessed using a Visual Analog Scale. Possible scores range from 0 (no pain) to 10 (Worst possible pain).
Outcome measures
| Measure |
Oral Analgesia Only
n=16 Participants
Group 1 will receive oral analgesia only
|
Anesthetic Continuous-Infusion + Oral Analgesia
n=21 Participants
Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
|
|---|---|---|
|
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
|
3.79 score on a scale
Standard Deviation 2.86
|
|
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
|
2.78 score on a scale
Standard Deviation 1.99
|
|
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
|
1.79 score on a scale
Standard Deviation 1.44
|
|
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
|
1.74 score on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: 4 daysPopulation: 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.
Parent responses to questions about pain management traditional paper-based Q method (TPQM) questionnaire.
Outcome measures
| Measure |
Oral Analgesia Only
n=30 Participants
Group 1 will receive oral analgesia only
|
Anesthetic Continuous-Infusion + Oral Analgesia
Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia
|
|---|---|---|
|
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
|
—
|
|
Parent and Patient Satisfaction With the Post Operative Pain Management.
Parent was "Very Satisfied" with child's pain management
|
22 Participants
|
—
|
|
Parent and Patient Satisfaction With the Post Operative Pain Management.
Parent was "Satisfied" with child's pain management.
|
7 Participants
|
—
|
|
Parent and Patient Satisfaction With the Post Operative Pain Management.
Parent was "Dissatisfied" with child's pain management.
|
1 Participants
|
—
|
|
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
|
—
|
Adverse Events
Oral Analgesia Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
An Anesthetic Infusion Device With Supplement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place