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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Analgesic Only | Active Comparator | Group 1 will receive oral analgesic only |
|
| anesthetic continuous-infusion + oral analgesia | Active Comparator | Group 2: anesthetic continuous-infusion device, e.g. intravenous analgesic per pump, with supplemental oral analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral analgesic | Drug | per clinical standard of care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Chang, MD | Children's Hospital Colorado | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital, Denver | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Analgesia Only | Group 1 will receive oral analgesia only |
| FG001 | Anesthetic Continuous-Infusion + Oral Analgesia | Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Group 1 will receive oral analgesia only |
| BG001 | Group 2 | Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | mg/kg | 4 days |
|
4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Analgesia Only | Group 1 will receive oral analgesia only | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Frank Chang | Children's Hospital Colorado | 720-777-6900 | Chang.Frank@tchden.org |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000700 | Analgesics |
| ID | Term |
|---|---|
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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| intravenous analgesic per pump |
| Drug |
per clinical standard of care |
|
| Femoral Stress Fracture |
|
| Pain Pump Complication |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 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). | Posted | Mean | Standard Deviation | score on a scale | 4 days |
|
|
|
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | An Anesthetic Infusion Device With Supplement | Group 2 will have an anesthetic continuous-infusion device with supplemental oral analgesia | 0 | 21 | 0 | 21 | 0 | 21 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D020164 | Chemical Actions and Uses |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
|
| Parent was "Dissatisfied" with child's pain management. |
|
| Parent would want their child's pain managed in the same way after another surgery |
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| Day 2 |
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| Day 3 |
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