Supracondylar Humerus FracturePhase 4NCT06187584

Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management

A Phase 4 study testing Hydrocodone/acetaminophen, Acetaminophen and Ibuprofen in people with Supracondylar Humerus Fracture, run by Children's Mercy Hospital Kansas City at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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. Read more about this study

Who is it for?: Ages 5 to 9 years
Conditions the study is for: Supracondylar Humerus Fracture
What is being tested?: Hydrocodone/acetaminophen, Acetaminophen and Ibuprofen
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 137 participants
Where: 1 siteUnited States
Study dates: 15 Apr 2019to 20 Dec 2023
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 5 to 9 years
All sexes
No healthy volunteers
Child

Who may be able to join

Patients presenting to Children's Mercy Hospital
Patients 48-119 months of age
Closed and completely displaced Gartland type III SCHFs (ICD-10 codes: S42.411A, S42.412A and S42.413A)

Who cannot join

Patients younger than 48 months of age or older than 120 months of age
Nondisplaced SCHFs (ICD-10): S42.414-, S42.415- and S42.416-)
Open and completely displaced Gartland type III SCHFs (ICD-10: S42.411B, S42.412B and S42.413B)
Injury requiring open reduction and/or vascular injury requiring treatment
Patients presenting with additional injuries
Patients with known allergy to medications used in this study

Show all 14Show fewer

Patients receiving regular treatment with opioids or NSAIDs
Patients with underlying medical issues affecting cognitive status
Patients with hepatic, gastrointestinal, renal or hematologic disease/disorders
Children that are wards of the state, prisoners or of CM employees
Non-English speaking families
Patients not admitted before and after surgery
Fractures not surgically treated within 18 hours of injury
Use of local anesthetic at surgical site

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Mercy Hospital & Clinics
Kansas City, Missouri, 64108

Other trials in United States

About this study

Official title: Nonopioid Versus Opioid Outpatient Pain Management Following Surgical Fixation of Gartland Type III Supracondylar Humerus Fractures in Children: A Prospective, Randomized Study

Read the detailed description

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.

Conditions: Supracondylar Humerus Fracture
Being tested: Hydrocodone/acetaminophen, Acetaminophen, Ibuprofen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hydrocodone/acetaminophenDrug
Hydrocodone/acetaminophen 0.15mg/kg PO q6
AcetaminophenDrug
15mg/kg PO q6 hours
IbuprofenDrug
10mg/kg PO q6 hours

Study groups in NCT06187584
Study group	Role	What they receive
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 Receives: Drug: Hydrocodone/acetaminophen; Drug: Ibuprofen
Experimental Group (nonopioid group):	Experimental	Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours Receives: Drug: Acetaminophen; Drug: Ibuprofen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).

Secondary outcomes (9)

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.
Measured: Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention
Number of Days of Medication Usage
Participants' parent completed a survey asking the number of days of medication use
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: First follow up visit, occurring approximately one week postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201920 Dec 2023

First posted2 Jan 2024
Study start15 Apr 2019
Primary completion20 Dec 2023
Study completion20 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (14)Papers the sponsor has linked to this study.
Other trials for Supracondylar Humerus FractureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Prospective, two-arm, parallel-group, randomized study conducted at a single center
Masking: None (open label)
Enrolment: 137 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06187584
Sponsor's protocol ID: STUDY00000286
Status last verified: Mar 2026
First submitted: 27 Nov 2023
Last updated: 31 Mar 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 24834350
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.
PubMed 17566399
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.
PubMed 24977679
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.
PubMed 24977680
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.
PubMed 29018084
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.
PubMed 24330523
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.
PubMed 28869906
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.
PubMed 25587948
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.
PubMed 23922249
Marquis, C.P., Cheung, G., Dwyer, J.S.M., et al. "Supracondylar fractures of the humerus". Current Orthopaedics. 2008;22:62-69.
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.
PubMed 29628707
Woon, C., Souder, C. and Skaggs, D. "Supracondylar Fracture - Pediatric". Orthobullets. https://www.orthobullets.com/pediatrics/4007/supracondylar-fracture--pediatric. (17 July 2018).
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.
PubMed 4375679
The Wong-Baker FACES Foundation: Faces of Pain Care. c2016. Published 2018. Wong-Baker FACES Foundation. [Accessed 11 Oct. 2018]. http://wongbakerfaces.org.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Anxiety Surrounding Supracondylar Pin Removal in Children: A Randomized Controlled Trial
Supracondylar Humerus Fracture, Anxiety
Not yet recruiting
Conservative Versus Surgical Treatment of Gartland Type II Supracondylar Humeral Fractures in Children - Which One ?
Humeral Fractures
RecruitingObservational study
EASY Algorithm Trial (Elbow Trauma Assessment Using Sonography in Children and Youth) Diagnostic Accuracy and Safety of Point-of-care Ultrasound as a Screening Tool for Suspected Elbow Fractures in Children Aged 5 to 15 Years: a Multicenter Prospective Cohort Study
Elbow Fractures, Distal Humerus Fracture
RecruitingPhase 4
Supracondylar Post-Operative Pain Study
Supracondylar Humerus Fracture
Not yet recruiting
Management of Vascular Complications in Pediatric Supracondylar Humerus Fractures
Vascular Complications, Supracondylar Humerus Fracture

All Supracondylar Humerus Fracture trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nonopioid Versus Opioid Outpatient Pain Management Following Surgical Fixation of Gartland Type III Supracondylar Humerus Fractures in Children: A Prospective, Randomized Study
ClinicalTrials.gov ID: NCT06187584
Acronym / sponsor ID: STUDY00000286
Conditions: Supracondylar Humerus Fracture
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 137 participants (actual)
Lead sponsor: Children's Mercy Hospital Kansas CityUniversity, hospital or other
Study start: 15 Apr 2019 (actual)
Primary completion: 20 Dec 2023 (actual)
Study completion: 20 Dec 2023 (actual)
First posted: 2 Jan 2024 (actual)
Results: Posted 31 Mar 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Prospective, two-arm, parallel-group, randomized study conducted at a single center

Arm	Type	Receives
Control Group (opioid group)	Active comparator	Drug: Hydrocodone/acetaminophen, Drug: IbuprofenHydrocodone/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	Drug: Acetaminophen, Drug: IbuprofenAcetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours

Who may qualify

Ages: 5 to 9 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Patients presenting to Children's Mercy Hospital
Patients 48-119 months of age
Closed and completely displaced Gartland type III SCHFs (ICD-10 codes: S42.411A, S42.412A and S42.413A)

Key exclusion criteria (14 listed)

Patients younger than 48 months of age or older than 120 months of age
Nondisplaced SCHFs (ICD-10): S42.414-, S42.415- and S42.416-)
Open and completely displaced Gartland type III SCHFs (ICD-10: S42.411B, S42.412B and S42.413B)
Injury requiring open reduction and/or vascular injury requiring treatment
Patients presenting with additional injuries

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hydrocodone/acetaminophenHydrocodone/acetaminophen 0.15mg/kg PO q6	Drug	Control Group (opioid group)
Acetaminophen15mg/kg PO q6 hours	Drug	Experimental Group (nonopioid group):
Ibuprofen10mg/kg PO q6 hours	Drug	Control Group (opioid group), Experimental Group (nonopioid group):

Primary outcome

Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.
Time frame: At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).
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.

9 secondary outcomes

Parent Satisfaction With (Subject) Child's Pain Control
Time frame: Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention
Number of Days of Medication Usage
Time frame: First follow up visit, occurring approximately one week postoperatively.
Side Effects From Medication
Time frame: First follow up visit, occurring approximately one week postoperatively.
Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain
Time frame: First follow up visit, occurring approximately one week postoperatively.
Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue
Time frame: First follow up visit, occurring approximately one week postoperatively.
Number of Visits to a Healthcare Provider for Breakthrough Pain Rescue
Time frame: First follow up visit, occurring approximately one week postoperatively.
Daily Use of Opioid or Nonopioid Medicine on Postoperative Days 1-5
Time frame: Postoperative days 1-5
Participant's Overall Pain Control
Time frame: First follow up visit, occurring approximately one week postoperatively.
Overall Parent Satisfaction
Time frame: First follow up visit, occurring approximately one week postoperatively.

Results and safety

Results posted to the registry on 31 Mar 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Group (Opioid Group)	41	41
Experimental Group (Nonopioid Group):	45	44

Primary outcome: Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale.

Time frame: At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).. Mean (Standard Deviation). Unit: units on a scale

Measure	Control Group (Opioid Group) n = 41	Experimental Group (Nonopioid Group): n = 44
Discharge pain level (baseline)	4.10 (2.05)	4.46 (2.55)
Post-operative Day 1 Pain Level	3.82 (2.43)	3.4 (2.53)
Post-operative Day 2 Pain Level	2.8 (2.14)	2.85 (2.06)
Post-operative Day 3 Pain Level	2.28 (2.19)	1.44 (1.54)
Post-operative Day 4 Pain Level	1.71 (1.51)	1.59 (1.55)
Post-operative Day 5 Pain Level	1.36 (1.45)	1.29 (1.32)

Population analysed: 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.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment to first follow up visit, which was approximately one week post-op.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Group (Opioid Group)	0 of 41 (0%)	0 of 41 (0%)	0 of 41
Experimental Group (Nonopioid Group):	0 of 44 (0%)	0 of 44 (0%)	0 of 44

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24834350Alkhoury 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.
Background: PubMed 17566399Tubbs 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.
Background: PubMed 24977679Tobias 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.
Background: PubMed 24977680Tobias 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.
Background: PubMed 29018084Poonai 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.
Background: PubMed 24330523Dorkham 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.
Background: PubMed 28869906Austin 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.
Background: PubMed 25587948Dart 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.
Background: PubMed 23922249Cartabuke 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.
BackgroundMarquis, C.P., Cheung, G., Dwyer, J.S.M., et al. "Supracondylar fractures of the humerus". Current Orthopaedics. 2008;22:62-69.
Background: PubMed 29628707Chaturvedi 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.
BackgroundWoon, C., Souder, C. and Skaggs, D. "Supracondylar Fracture - Pediatric". Orthobullets. https://www.orthobullets.com/pediatrics/4007/supracondylar-fracture--pediatric. (17 July 2018).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Hydrocodone/acetaminophen, Acetaminophen and Ibuprofen in people with Supracondylar Humerus Fracture, run by Children's Mercy Hospital Kansas City at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject Reported Pain Level Using the Wong-Baker Faces Pain Scale. (time frame: At the relative same time each day at time of discharge (baseline) and postoperative days 1-5 (i.e., five follow-up measures).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06187584, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.