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

NCT04905563 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: Post-op SCHF Pain
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Supracondylar Humerus Fracture

Keywords

Elbow surgery; Pain

Outcome Measures

Primary Outcomes (1)

• Pain Scores

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

  24 hours (duration of post-operative stay)

Study Arms (2)

Control

OTHER

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

Drug: Acetaminophen-Hydrocodone

Treatment

EXPERIMENTAL

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.

Drug: Acetaminophen and Ibuprofen

Interventions

Acetaminophen-Hydrocodone DRUG

Narcotic

Also known as: Lortab

Control

Acetaminophen and Ibuprofen DRUG

Non-narcotic

Also known as: Tylenol and Advil

Treatment

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead
• The Campbell Foundation: collaborator

Study Sites (1)

Le Bonheur Children's Hospital

Memphis, Tennessee, 38104, United States

Location

MeSH Terms

Conditions

Pain

Interventions

oxycodone-acetaminophen; Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Lindsey Locke, MSN
• Organization: Le Bonheur Children's Hospital

lindsey.locke@lebonheur.org

(901) 287-8931

Study Officials

• Lindsey Locke, MSN

  Le Bonheur Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Nurse Practitioner

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 27, 2021
• Study Start: June 7, 2021
• Primary Completion: January 5, 2024
• Study Completion: January 5, 2024
• Last Updated: March 8, 2024
• Results First Posted: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)