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

NCT06187584 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00000286
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Supracondylar Humerus Fracture

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (9)

• Parent Satisfaction With (Subject) Child's Pain Control

  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

  First follow up visit, occurring approximately one week postoperatively.

• Side Effects From Medication

  First follow up visit, occurring approximately one week postoperatively.

• Use of Medication(s) Other Than Those Indicated by Their Physician to Control Pain

  First follow up visit, occurring approximately one week postoperatively.

• Number of Calls to a Healthcare Provider for Breakthrough Pain Rescue

  First follow up visit, occurring approximately one week postoperatively.

Study Arms (2)

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

Drug: Hydrocodone/acetaminophen; Drug: Ibuprofen

Experimental Group (nonopioid group):

EXPERIMENTAL

Acetaminophen 15mg/kg PO q6 hours with ibuprofen 10mg/kg PO q6 hours

Drug: Acetaminophen; Drug: Ibuprofen

Interventions

Hydrocodone/acetaminophen DRUG

Hydrocodone/acetaminophen 0.15mg/kg PO q6

Control Group (opioid group)

Acetaminophen DRUG

15mg/kg PO q6 hours

Experimental Group (nonopioid group):

Ibuprofen DRUG

10mg/kg PO q6 hours

Control Group (opioid group); Experimental Group (nonopioid group):

Eligibility Criteria

• Age: 5 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital & Clinics

Kansas City, Missouri, 64108, United States

Location

Related Publications (14)

• 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.

  PMID: 24834350 BACKGROUND

• 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.

  PMID: 17566399 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.

  PMID: 24977679 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.

  PMID: 24977680 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.

  PMID: 29018084 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.

  PMID: 24330523 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.

  PMID: 28869906 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.

  PMID: 25587948 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.

  PMID: 23922249 BACKGROUND

• Marquis, C.P., Cheung, G., Dwyer, J.S.M., et al. "Supracondylar fractures of the humerus". Current Orthopaedics. 2008;22:62-69.

  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.

  PMID: 29628707 BACKGROUND

• Woon, C., Souder, C. and Skaggs, D. "Supracondylar Fracture - Pediatric". Orthobullets. https://www.orthobullets.com/pediatrics/4007/supracondylar-fracture--pediatric. (17 July 2018).

  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.

  PMID: 4375679 BACKGROUND

• The Wong-Baker FACES Foundation: Faces of Pain Care. c2016. Published 2018. Wong-Baker FACES Foundation. [Accessed 11 Oct. 2018]. http://wongbakerfaces.org.

  BACKGROUND

MeSH Terms

Interventions

oxycodone-acetaminophen; Acetaminophen; Ibuprofen

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Limitations and Caveats

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.

Results Point of Contact

• Title: Caleb Grote, MD
• Organization: Children's Mercy Hospital

csgrote@cmh.edu

8162343693

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, MD/PhD

Model Details: Prospective, two-arm, parallel-group, randomized study conducted at a single center

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: January 2, 2024
• Study Start: April 15, 2019
• Primary Completion: December 20, 2023
• Study Completion: December 20, 2023
• Last Updated: March 31, 2026
• Results First Posted: March 31, 2026

Record last verified: 2026-03

Locations

US (1)