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This purpose of this study is to determine the efficacy of nonopioid versus opioid analgesic regimens following surgical fixation of Gartland Type III Supracondylar Humoral Fractures (SCHFs) to assist in the development of a standard outpatient pain management regimen in the treatment of these injuries.
Pain is variably managed in pediatric populations, particularly in the postoperative outpatient setting. The lack of data describing and supporting the safety and efficacy of the use of analgesic drugs in children is a major contributor to this problem. Postoperative prescription opioids have been associated with high rates of morbidity and mortality in children and identified as a pathway to future opioid abuse. With increasing public awareness regarding these issues surrounding opioid use and no evidence to support superior treatment outcomes in children with the use of opioids, there is a pressing need for data to guide healthcare providers in choosing analgesic drugs to treat postoperative pain in pediatric patients.
Prior studies have evaluated the use of nonopioid versus opioid analgesic drugs in the outpatient setting following pediatric ambulatory surgery. These studies found nonopioid analgesics, such as acetaminophen and ibuprofen, to be as equally effective as opioid analgesics, including morphine, codeine and oxycodone. Further, the use of nonopioid analgesics was associated with significantly fewer side effects. These findings imply that nonopioid analgesics may be a superior initial therapy following ambulatory surgery.
However, no study has evaluated the use of nonopioid versus opioid analgesic regimens in the outpatient setting following surgical fixation of supracondylar humerus fractures (SCHFS). SCHFs are the second most common fracture in children, often requiring urgent surgical intervention. Despite their frequency, there is no standard for postoperative outpatient pain management in the treatment of these injuries.
Almost all SCHFs can be described according to the Gartland classification. The Gartland classification delineates three types of SCHFs. Gartland type I fractures are nondisplaced and do not require surgical intervention, while Gartland type II fractures are angulated, but maintain an intact posterior cortex. These may or may not require surgical intervention. However, Gartland type III fractures are completely displaced with no posterior cortical contact and require surgical intervention with either closed reduction and percutaneous pinning (CRPP) or open reduction with percutaneous pinning (ORPP). This study will look at only Gartland type III SCHFs because they necessitate surgical intervention, most commonly CRPP.
Investigators hypothesize that there is no difference in daily pain levels for nonopioid analgesic regimens compared to opioid analgesic regimens in management of post-operative pain in the outpatient period following surgical fixation of Gartland type III supracondylar humerus fracture in children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (opioid group) | Active Comparator | Hydrocodone/acetaminophen 0.15mg/kg by mouth (PO) every (q) 6 hours as needed (PRN) with ibuprofen 10mg/kg PO q6 hours PRN |
|
| Experimental Group (nonopioid group): | Experimental | Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocodone/acetaminophen | Drug | Hydrocodone/acetaminophen 0.15mg/kg PO q6 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale. | The subject reported pain level using the scale 0-10, with 0 being no pain and 10 being worst pain, will be measured at the time of discharge (i.e., baseline measure) and once daily at the relative same time each day on postoperative days 1-5. Thus, subjects may have up to a total of six pain level measurements. Higher scores mean a worse outcome. | At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures). |
| Measure | Description | Time Frame |
|---|---|---|
| Parent Satisfaction With (Subject) Child's Pain Control | Using the Likert scale 1-5, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators asked families to rate the satisfaction of their child's pain control daily for 5 days. The higher the number, the higher the satisfaction. | Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Mercy Hospital & Clinics | Kansas City | Missouri | 64108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24834350 | Background | Alkhoury F, Knight C, Stylianos S, Zerpa J, Pasaron R, Mora J, Aserlind A, Malvezzi L, Burnweit C. Prospective Comparison of Nonnarcotic versus Narcotic Outpatient Oral Analgesic Use after Laparoscopic Appendectomy and Early Discharge. Minim Invasive Surg. 2014;2014:509632. doi: 10.1155/2014/509632. Epub 2014 Apr 14. | |
| 17566399 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group (Opioid Group) | Hydrocodone/acetaminophen 0.15mg/kg by mouth (PO) every (q) 6 hours as needed (PRN) with ibuprofen 10mg/kg PO q6 hours PRN Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6 Ibuprofen: 10mg/kg PO q6 hours |
| FG001 | Experimental Group (Nonopioid Group): | Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours Acetaminophen: 15mg/kg PO q6 hours Ibuprofen: 10mg/kg PO q6 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group (Opioid Group) | Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6 Ibuprofen: 10mg/kg PO q6 hours |
| BG001 | Experimental Group (Nonopioid Group): |
| 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 | Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale. | The subject reported pain level using the scale 0-10, with 0 being no pain and 10 being worst pain, will be measured at the time of discharge (i.e., baseline measure) and once daily at the relative same time each day on postoperative days 1-5. Thus, subjects may have up to a total of six pain level measurements. Higher scores mean a worse outcome. | Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future. | Posted | Mean | Standard Deviation | units on a scale | At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures). |
|
From enrollment to first follow up visit, which was approximately one week post-op.
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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 | Control Group (Opioid Group) | Hydrocodone/acetaminophen 0.15mg/kg PO q6 hours PRN with ibuprofen 10mg/kg PO q6 hours PRN Hydrocodone/acetaminophen: Hydrocodone/acetaminophen 0.15mg/kg PO q6 Ibuprofen: 10mg/kg PO q6 hours |
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Out of 137 enrolled participants, 51 were removed from study due to ineligibility or consenting errors by study staff. This led to a smaller number of subjects analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Caleb Grote, MD | Children's Mercy Hospital | 8162343693 | csgrote@cmh.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 4, 2025 | Feb 11, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C514822 | oxycodone-acetaminophen |
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Prospective, two-arm, parallel-group, randomized study conducted at a single center
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| Acetaminophen |
| Drug |
15mg/kg PO q6 hours |
|
| Ibuprofen | Drug | 10mg/kg PO q6 hours |
|
| Number of Days of Medication Usage | Participants' parent completed a survey asking the number of days of medication use | First follow up visit, occurring approximately one week postoperatively. |
| Side Effects From Medication | Participant completed a Yes/No survey asking if they experienced any of the following: Nausea, Vomiting, Constipation, Headache, Dizziness, Drowsiness, Rash, Other. | First follow up visit, occurring approximately one week postoperatively. |
| Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain | Participant completed a Yes/No survey asking if use of medication other than those indicated by their physician to control pain occured. | First follow up visit, occurring approximately one week postoperatively. |
| Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue | Participant completed a survey asking for numerical count of phone calls for pain rescue. | First follow up visit, occurring approximately one week postoperatively. |
| Number of Visits to a Healthcare Provider for Breakthrough Pain Rescue | Participant completed survey asking for count of visits for pain rescue. | First follow up visit, occurring approximately one week postoperatively. |
| Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5 | Survey for number of doses taken by participant each postoperative day 1-5 | Postoperative days 1-5 |
| Participant's Overall Pain Control | Participant completed survey using 5 point Likert scale "very poorly", "poorly", "neutral", "well", "very well". Very poorly = 1, Poorly = 2, Neutral = 3, Well = 4, Very well = 5 | First follow up visit, occurring approximately one week postoperatively. |
| Overall Parent Satisfaction | Using the Likert scale, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators ask families to rate overall their satisfaction with their child's pain control in the first five days after surgery. | First follow up visit, occurring approximately one week postoperatively. |
| Tubbs RS, Law C, Davis D, Shoja MM, Acakpo-Satchivi L, Wellons JC 3rd, Blount JP, Oakes WJ. Scheduled oral analgesics and the need for opiates in children following partial dorsal rhizotomy. J Neurosurg. 2007 Jun;106(6 Suppl):439-40. doi: 10.3171/ped.2007.106.6.439. |
| 24977679 | Background | Tobias JD. Acute pain management in infants and children-Part 1: Pain pathways, pain assessment, and outpatient pain management. Pediatr Ann. 2014 Jul;43(7):e163-8. doi: 10.3928/00904481-20140619-10. |
| 24977680 | Background | Tobias JD. Acute pain management in infants and children-Part 2: Intravenous opioids, intravenous nonsteroidal anti-inflammatory drugs, and managing adverse effects. Pediatr Ann. 2014 Jul;43(7):e169-75. doi: 10.3928/00904481-20140619-11. |
| 29018084 | Background | Poonai N, Datoo N, Ali S, Cashin M, Drendel AL, Zhu R, Lepore N, Greff M, Rieder M, Bartley D. Oral morphine versus ibuprofen administered at home for postoperative orthopedic pain in children: a randomized controlled trial. CMAJ. 2017 Oct 10;189(40):E1252-E1258. doi: 10.1503/cmaj.170017. |
| 24330523 | Background | Dorkham MC, Chalkiadis GA, von Ungern Sternberg BS, Davidson AJ. Effective postoperative pain management in children after ambulatory surgery, with a focus on tonsillectomy: barriers and possible solutions. Paediatr Anaesth. 2014 Mar;24(3):239-48. doi: 10.1111/pan.12327. Epub 2013 Dec 11. |
| 28869906 | Background | Austin AE, Shanahan ME, Zvara BJ. Association of childhood abuse and prescription opioid use in early adulthood. Addict Behav. 2018 Jan;76:265-269. doi: 10.1016/j.addbeh.2017.08.033. Epub 2017 Sep 1. |
| 25587948 | Background | Dart RC, Surratt HL, Cicero TJ, Parrino MW, Severtson SG, Bucher-Bartelson B, Green JL. Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med. 2015 Jan 15;372(3):241-8. doi: 10.1056/NEJMsa1406143. |
| 23922249 | Background | Cartabuke RS, Tobias JD, Taghon T, Rice J. Current practices regarding codeine administration among pediatricians and pediatric subspecialists. Clin Pediatr (Phila). 2014 Jan;53(1):26-30. doi: 10.1177/0009922813498151. Epub 2013 Aug 5. |
| Background | Marquis, C.P., Cheung, G., Dwyer, J.S.M., et al. "Supracondylar fractures of the humerus". Current Orthopaedics. 2008;22:62-69. |
| 29628707 | Background | Chaturvedi H, Khanna V, Bhargava R, Vaishya R. Predictive factors determining outcomes in pulseless limb in paediatric supracondylar fractures of humerus. J Clin Orthop Trauma. 2018 Mar;9(Suppl 1):S92-S96. doi: 10.1016/j.jcot.2017.10.009. Epub 2017 Oct 31. |
| Background | Woon, C., Souder, C. and Skaggs, D. "Supracondylar Fracture - Pediatric". Orthobullets. https://www.orthobullets.com/pediatrics/4007/supracondylar-fracture--pediatric. (17 July 2018). |
| 4375679 | Background | Flynn JC, Matthews JG, Benoit RL. Blind pinning of displaced supracondylar fractures of the humerus in children. Sixteen years' experience with long-term follow-up. J Bone Joint Surg Am. 1974 Mar;56(2):263-72. No abstract available. |
| Background | The Wong-Baker FACES Foundation: Faces of Pain Care. c2016. Published 2018. Wong-Baker FACES Foundation. [Accessed 11 Oct. 2018]. http://wongbakerfaces.org. |
Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours Acetaminophen: 15mg/kg PO q6 hours Ibuprofen: 10mg/kg PO q6 hours |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Experimental Group (Nonopioid Group): | Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours Acetaminophen: 15mg/kg PO q6 hours Ibuprofen: 10mg/kg PO q6 hours |
|
|
| Secondary | Parent Satisfaction With (Subject) Child's Pain Control | Using the Likert scale 1-5, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators asked families to rate the satisfaction of their child's pain control daily for 5 days. The higher the number, the higher the satisfaction. | Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future. For each post-operative day, not all of the participants filled out the survey every single day, thus the numbers vary by day. | Posted | Mean | Standard Deviation | units on a scale | Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention |
|
|
|
| Secondary | Number of Days of Medication Usage | Participants' parent completed a survey asking the number of days of medication use | Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future. | Posted | Mean | Standard Deviation | number of days | First follow up visit, occurring approximately one week postoperatively. |
|
|
|
| Secondary | Side Effects From Medication | Participant completed a Yes/No survey asking if they experienced any of the following: Nausea, Vomiting, Constipation, Headache, Dizziness, Drowsiness, Rash, Other. | Number of participants analyzed is lower than enrollment number because not all participants filled out a survey at their 1st follow up visit. Count of participants in the Outcome Measure Data Table is count of how many answered "yes" to side effects. | Posted | Count of Participants | Participants | First follow up visit, occurring approximately one week postoperatively. |
|
|
|
| Secondary | Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain | Participant completed a Yes/No survey asking if use of medication other than those indicated by their physician to control pain occured. | Number of participants analyzed is lower than enrolled participants because not all participants completed a survey at their first follow up visit. The count of participants in the Outcome Measure Data Table indicates how many participants answered "yes". | Posted | Count of Participants | Participants | First follow up visit, occurring approximately one week postoperatively. |
|
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| Secondary | Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue | Participant completed a survey asking for numerical count of phone calls for pain rescue. | Number of participants analyzed is lower than enrolled participants because not all participants completed a survey at their first follow up visit. The count of participants in the Outcome Measure Data Table indicates how many participants called provider for pain rescue. | Posted | Count of Participants | Participants | First follow up visit, occurring approximately one week postoperatively. |
|
|
|
| Secondary | Number of Visits to a Healthcare Provider for Breakthrough Pain Rescue | Participant completed survey asking for count of visits for pain rescue. | Number of participants analyzed is lower than enrolled participants because not all participants completed a survey at their first follow up visit. The count of participants in the Outcome Measure Data Table indicates how many participants answered "yes". | Posted | Number | Number of visits | First follow up visit, occurring approximately one week postoperatively. |
|
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| Secondary | Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5 | Survey for number of doses taken by participant each postoperative day 1-5 | Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future. | Posted | Mean | Standard Deviation | medication doses | Postoperative days 1-5 |
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| Secondary | Participant's Overall Pain Control | Participant completed survey using 5 point Likert scale "very poorly", "poorly", "neutral", "well", "very well". Very poorly = 1, Poorly = 2, Neutral = 3, Well = 4, Very well = 5 | Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future. | Posted | Mean | Standard Deviation | units on a scale | First follow up visit, occurring approximately one week postoperatively. |
|
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| Secondary | Overall Parent Satisfaction | Using the Likert scale, "very dissatisfied (1), dissatisfied (2), neutral (3), satisfied (4), very satisfied (5)" options, the investigators ask families to rate overall their satisfaction with their child's pain control in the first five days after surgery. | Overall number of participants analyzed was lower than enrollment number because some participants did not complete any survey data. We don't have that data and do not have the collect it in the future. | Posted | Mean | Standard Deviation | units on a scale | First follow up visit, occurring approximately one week postoperatively. |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Experimental Group (Nonopioid Group): | Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours Acetaminophen: 15mg/kg PO q6 hours Ibuprofen: 10mg/kg PO q6 hours | 0 | 44 | 0 | 44 | 0 | 44 |
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| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| Post op day 2 satisfaction level |
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| Post op day 3 satisfaction level |
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| Post op day 4 satisfaction level |
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| Post op day 5 satisfaction level |
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| Post op Day 2 Number of medication doses |
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| Post op Day 3 Number of medication doses |
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| Post op Day 4 Number of medication doses |
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| Post op Day 5 Number of medication doses |
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