Clinical trial NCT06187584: SCHF Post-Op Study Between Opioid and Non-Opioid Pain Management
Official title: Nonopioid Versus Opioid Outpatient Pain Management Following Surgical Fixation of Gartland Type III Supracondylar Humerus Fractures in Children: A Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Supracondylar Humerus Fracture
Lead sponsor: Children's Mercy Hospital Kansas City
Sponsor class: OTHER
First posted: 2024-01-02
Enrollment: 160
Sex: ALL
Minimum age (years): 5
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, two-arm, parallel-group, randomized study conducted at a single center
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary outcome will be subject reported pain level using the Wong-Baker Faces Pain Scale.
timeFrame: At the relative same time each day on postoperative days 1-5 (i.e., five follow-up measures).
Secondary outcomes:
measure: Parent satisfaction with (subject) child's pain control
timeFrame: Two hours post intervention and everyday at the same time as the initial response for five consecutive days post intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Children's Mercy Hospital & Clinics
state: Missouri
Study officials:
References:
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