SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management

Supracondylar Humerus Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06187584
• Other study ID #: STUDY00000286
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: April 15, 2019
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Humeral Fractures
• Supracondylar Humerus Fracture

Intervention

Drug:
• Hydrocodone/acetaminophen
Hydrocodone/acetaminophen 0.15mg/kg PO q6
• Acetaminophen
15mg/kg PO q6 hours
• Ibuprofen
10mg/kg PO q6 hours

Locations

Country	Name	City	State
United States	Children's Mercy Hospital & Clinics	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be subject reported pain level using the Wong-Baker Faces Pain Scale.	The subject reported pain level using the scale 0-10, will be measured at the time of discharge (i.e., baseline measure).	At the relative same time each day on postoperative days 1-5 (i.e., five follow-up measures).
Secondary	Parent satisfaction with (subject) child's pain control	Using the Likert scale, "very dissatisfied, dissatisfied, neutral, satisfied, very satisfied" options, the investigators ask families to rate the satisfaction of their child's pain control daily for 5 days.	Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention