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The goal of this study is to compare different ways of treating pain after surgery. This research study involves subjects who have a supracondylar elbow fracture and need surgery. This type of fracture occurs when the humerus (upper arm bone) is broken just above the elbow. Like any other surgery, you can expect that you will feel pain in the hours or days after the operation. Currently, despite the common occurrence of this surgery, there is not a standard way to treat and or prevent any of the pain afterwards.
At this hospital, oral (take by mouth) pain medicine is commonly used to treat pain after this surgery.
In this study, pain will be treated in one of the following ways:
The correct dosages of all drugs will be safely prescribed by the doctor on an individual basis and all drugs will be used under the careful watch of your attending physician. All the drugs used this study are approved by the FDA for use in adults but they are not specifically approved for use in children. However, nearly 7 out of every 10 drugs approved for adults are not specifically approved by the FDA for use in children. All drugs used in this study will be used in a way that is considered to be safe and reasonable by the Children's Hospital.
Purpose: In recent years, despite the lack of consistent evidence, the use of intraarticular (into the joint)injections during ambulatory, orthopaedic surgery has become a popular strategy for reducing post-operative pain. In this randomized, single center, prospective study the investigators will evaluate the analgesic effectiveness of intraarticular injections of local anesthesia during the closed reduction and percutaneous pinning (CRPP) of supracondylar type elbow fractures (SCEFx) in children. In order to determine the efficacy of intraarticular injections, perceived post-operative pain will be compared among the three study groups receiving either a 0.25 % intraarticular injection of bupivacaine (Group 1 ), a 0.20% intraarticular injection of ropivacaine (Group 2) or no intraarticular injection (Control). All groups will receive the same post-operative oral pain medication of oxycodone (0.1 to 0.15 mg/kg) with acetaminophen.
Primary Aim(s) : Compare the primary and secondary pain outcomes variables in each of the three study groups.
The primary pain outcome variables are defined as the following:
The secondary pain outcome variables are defined as the following:
Hypotheses for Primary Aims:
Secondary Aim I: Evaluate the overall effect gender, ethnicity, age, American Society of Anesthesiologists (ASA) classification, fracture type and anesthesia time have on the pain outcome variables in this study population:
Hypotheses for Secondary Aim I: The investigators expect that age, gender, ASA classification, fracture type and anesthesia time will have a significant effect of on the primary and secondary pain outcome variables in this study population as a whole.
Secondary Aim II: Evaluate the overall effect that gender, ethnicity, age, ASA classification (I, II or III),fracture type and anesthesia time have on the pain outcome variables in each of the study groups (Compare 1, 2 and Control to study population as a whole).
Hypotheses for Secondary Aim II: The investigators anticipate that there will be no group difference in the effects that age, gender, ASA classification, fracture type or anesthesia time have on the primary and secondary pain outcome variables.
Secondary Aim III: Compare Group 1 and Group 2 for a potential dose dependent relationship between reported pain outcome variables and total dose of intraarticular injection.
Hypotheses for Secondary Aim III: In both groups, the investigators anticipate there will be a non-significant association between an increased dose of local anesthetic and decreased post-operative FSP-R scores. There will not be any difference in the significance of this dose dependent relationship between Group I and Group 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The group receiving oral pain medicine | Active Comparator | This group will receive Oxycodone with Acetaminophen orally |
|
| The group receiving bupivacaine and oral pain medicine | Active Comparator | This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed. |
|
| The group receiving ropivacaine and oral pain medicine | Active Comparator | This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone with Acetaminophen | Drug | 0.1- 0.15 mg/kg (oxycodone) every 4-6 hours as needed. Pills: 325 mg acetaminophen: 5 mg oxycodone per tablet. Liquid: 325 mg acetaminophen:5 mg oxycodone per 5 mL. |
| Measure | Description | Time Frame |
|---|---|---|
| The Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10). | The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. | Will be obtained 30 - 60 minutes after arrival to the recovery room |
| Measure | Description | Time Frame |
|---|---|---|
| Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting | Total quality pain management survey is validated survey used to assess parents' perceptions of their child's pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital | Aurora | Colorado | 80045 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Narcotic Group | This group will receive Oxycodone with Acetaminophen orally |
| FG001 | Bupivacaine Group | This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed. |
| FG002 | Ropivacaine Group | This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Narcotic Group | This group will receive Oxycodone with Acetaminophen orally |
| BG001 | Bupivacaine Group | This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed. |
| 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 Faces Pain Scale-Revised (FSP-R) Scores (Scored 0-10). | The Faces Pain Scale Revised is a dimensionless 10 point likert scale used to assess self-reported pain intensity on a scale from 0 (no pain) to 10 (most pain you can imagine). Greater pain scores are indicative of more severe pain. | Based on the number of participants that self-reported their pain score. | Posted | Mean | Standard Deviation | Scores on a scale | Will be obtained 30 - 60 minutes after arrival to the recovery room |
|
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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 Narcotic Group | This group will receive Oxycodone with Acetaminophen orally |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gaia Georgopoulos, MD | Children's Hospital Colorado | 720-777-2588 | Gaia.Georgopoulos@childrenscolorado.org |
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| ID | Term |
|---|---|
| D000092482 | Elbow Fractures |
| D050723 | Fractures, Bone |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D000092464 | Elbow Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D010468 | Perceptual Disorders |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D000082 | Acetaminophen |
| C514822 | oxycodone-acetaminophen |
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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|
| Bupivacaine 0.25% | Drug |
|
|
|
| Ropivacaine 0.20% | Drug |
|
|
|
| Will be obtained from parent(s) 120 minutes after arrival to the recovery room |
| Time (in Minutes) to First Narcotic Administration | first 72 hours after surgery close time |
| Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge | Analgesic data collected during first four hours following the end of surgery (surgery close) |
| Need for IV Morphine of Fentanyl | Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl. | First 120 minutes after the end of surgery (surgery close time) |
| BG002 | Ropivacaine Group | This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed. |
| BG003 | 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 |
|
| OG002 | Ropivacaine Group | This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed. |
|
|
|
| Secondary | Total Quality Pain Management Survey (TQPM) Scores for Questions # 16: Child's Current Level of Pain, Question # 17: Child's Worst Level of Pain When Moving Around After Surgery and Question # 18: Child's Worst Level of Pain While Resting | Total quality pain management survey is validated survey used to assess parents' perceptions of their child's pain. Pain is assessed on a dimensionless 10 pt likert scale from 0 (no pain) to 10 (severe pain). Greater pain scores are indicative or more severe pain. | Based on number of participants and their parents/legal guardians that completed the survey. | Posted | Mean | Standard Deviation | Scores on a scale | Will be obtained from parent(s) 120 minutes after arrival to the recovery room |
|
|
|
|
| Secondary | Time (in Minutes) to First Narcotic Administration | All subjects were included in the analysis. | Posted | Median | Inter-Quartile Range | Minutes | first 72 hours after surgery close time |
|
|
|
|
| Secondary | Total Dosage in Morphine Equivalents (mg/kg) of All Analgesics Received in Prior to Discharge | All subjects were included in the analysis. | Posted | Mean | Standard Deviation | Morphine (po) equivalents [mg*kg-1] | Analgesic data collected during first four hours following the end of surgery (surgery close) |
|
|
|
|
| Secondary | Need for IV Morphine of Fentanyl | Indicates that number of subjects that were in severe pain and thus required IV morphine and/or fentanyl. | All subjects were included in the analysis. | Posted | Number | participants | First 120 minutes after the end of surgery (surgery close time) |
|
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | Bupivacaine Group | This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed. | 0 | 42 | 0 | 42 |
| EG002 | Ropivacaine Group | This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed. | 0 | 39 | 0 | 39 |
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| D019954 |
| Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| Mean Difference (Net) |
| 0.16 |
| 95 |
| -1.30 |
| 1.61 |
| No |
| Superiority or Other |
| ANOVA | 0.027 | Mean Difference (Final Values) | 1.66 | 95 | 0.20 | 3.12 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Log Rank | 0.039 | 95 | No | Superiority or Other |
| Mean Difference (Final Values) |
| 0.031 |
| 95 |
| -0.004 |
| 0.066 |
| No |
| Superiority or Other |
| ANOVA | 0.5321 | Mean Difference (Final Values) | 0.011 | 95 | -0.024 | 0.045 | No | Superiority or Other |
| 95 |
| No |
| Superiority or Other |
| Chi-squared | 0.499 | 95 | No | Superiority or Other |