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NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures

Primary Purpose

Supracondylar Humerus Fracture

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Acetaminophen-Hydrocodone
Acetaminophen and Ibuprofen
Sponsored by
Le Bonheur Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Supracondylar Humerus Fracture focused on measuring Elbow surgery, Pain

Eligibility Criteria

4 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • isolated supracondylar humerus fracture
  • undergoing closed reduction with percutaneous pinning (CRPP)

Exclusion Criteria:

  • Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone
  • Liver or renal disease
  • history of bleeding disorder
  • medical diagnosis of juvenile arthritis
  • on chronic NSAIDs or Opioids PRIOR to the procedure
  • medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma)
  • vascular compromise and/or compartment syndrome upon admission

Sites / Locations

  • Le Bonheur Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Treatment

Arm Description

Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose

Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.

Outcomes

Primary Outcome Measures

Pain scores
Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).

Secondary Outcome Measures

Full Information

First Posted
May 21, 2021
Last Updated
March 7, 2023
Sponsor
Le Bonheur Children's Hospital
Collaborators
The Campbell Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04905563
Brief Title
NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures
Official Title
Post-operative Pain Management in Supracondylar Humerus Fractures: A Randomized, Double-blinded, Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2021 (Actual)
Primary Completion Date
May 21, 2025 (Anticipated)
Study Completion Date
May 21, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Le Bonheur Children's Hospital
Collaborators
The Campbell Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine if using the combination of acetaminophen (also known as Tylenol) and ibuprofen (also known as Motrin or Advil) will provide equal or better pain control as compared to acetaminophen-hydrocodone (also known as Lortab), in children with broken elbows who need surgery. This study will examine whether the combination of acetaminophen and ibuprofen can provide pain control as well as or better than acetaminophen-hydrocodone so that doctors might be able to prescribe less acetaminophen-hydrocodone (which can be addictive) to children in the future. Currently, the standard of care for pain control following this kind of elbow surgery is acetaminophen-hydrocodone.
Detailed Description
For this study, participants will be randomized (randomly assigned) to either receive scheduled acetaminophen-hydrocodone (which is the current standard of care treatment) or acetaminophen and ibuprofen (the experimental treatment) for post operative pain control following surgery for supracondylar humerus fracture. Patients in the experimental treatment group who require 2 doses of breakthrough pain medication in a row in order to control their pain will be switched to the standard of care treatment. Follow up information regarding outcomes post-discharge will be collected via secure email or text 48-72 hours post-discharge.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Supracondylar Humerus Fracture
Keywords
Elbow surgery, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Standard of care- weight based dose of liquid acetaminophen-hydrocodone- 0.15 mg/kg/dose every six hours with a max dose of 10 mg/dose
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Weight based dose of liquid acetaminophen and ibuprofen- acetaminophen 15 mg/kg/dose and ibuprofen 10 mg/kg/dose every six hours with a max dose of 650 mg/dose of acetaminophen and 600 mg/dose of ibuprofen.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen-Hydrocodone
Other Intervention Name(s)
Lortab
Intervention Description
Narcotic
Intervention Type
Drug
Intervention Name(s)
Acetaminophen and Ibuprofen
Other Intervention Name(s)
Tylenol and Advil
Intervention Description
Non-narcotic
Primary Outcome Measure Information:
Title
Pain scores
Description
Pain scores during postoperative hospital stay on a Wong-Baker Faces scale. 0 (No Pain) to 10 (Worst pain).
Time Frame
24 hours (duration of post-operative stay)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: isolated supracondylar humerus fracture undergoing closed reduction with percutaneous pinning (CRPP) Exclusion Criteria: Allergies to acetaminophen, ibuprofen, and/or acetaminophen-HYDROcodone Liver or renal disease history of bleeding disorder medical diagnosis of juvenile arthritis on chronic NSAIDs or Opioids PRIOR to the procedure medical diagnosis of coagulopathies, open fractures, other injuries at time of diagnosis (multi-system trauma) vascular compromise and/or compartment syndrome upon admission
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Rowland, BS, CCRP
Phone
901-287-5413
Email
jonathan.rowland@lebonheur.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Locke, MSN
Organizational Affiliation
Le Bonheur Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Le Bonheur Children's Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Rowland, BS, CCRP
Phone
901-287-5413
Email
jonathan.rowland@lebonheur.org
First Name & Middle Initial & Last Name & Degree
Lindsey Locke, MSN
Phone
901-287-8931
Email
lindsey.locke@lebonheur.org
First Name & Middle Initial & Last Name & Degree
Lindsey Locke, MSN

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No Plan has been made for such data sharing

Learn more about this trial

NSAIDs vs Opioids for Post-op Pain in Supracondylar Humerus Fractures

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